Q & A. FDA. Hair. Scars. Money Back.

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Charles Runels: All right. So we had quite a few interesting questions over the past few weeks so let’s just jump right into it. The first one, Dave Harshfield sent me some guidelines that he keeps up with. He’s the head of an orthopedic groups that does a lot of regenerative medicine and he and others have [inaudible 00:00:22] to me these latest updates that came up by the FDA. So I thought I should show them to you because they should be very reassuring to you about what we do.

So here’s the question. If you haven’t gotten this question [inaudible 00:00:35], you will get it. Like I said, we’re going to cover about the FDA, we will cover a couple of marketing things, and then I’m going to go over a receipt that you can you when you give back to people who may not be happy. Everyone’s not going to love what we do and I have a receipt that makes people happy, it keeps you legally clean that I’ll show you. Then we’ll go over some resource that has to do with Platelet Rich Plasma scaring. Plus a few other questions. So let’s see. There are quite a few of you on the call and hopefully some of you can participate with helping answering some of these questions.

Is the O-Shot® FDA Approved?

But first, let’s talk about the FDA and how to answer this question about “Is the O-Shot FDA approved? Is the Platelet shot FDA approved? Is the Vampire Facelift FDA approved?” So the beginning of the answer to that question is that the FDA does not control your body fluids. Doesn’t control your hair, your [inaudible 00:01:42], your saliva. That belongs to you. Your fingers, your toes. The FDA is the food, drug, and device administration. However, if you [inaudible 00:01:52] enough to the material that it quits being your body and becomes a drug, then the FDA does have jurisdiction and the FDA has jurisdiction over the devices you might use to prepare the blood.

So, the analogy I use and some of you have heard me say this in my classes is that if you have suture material that you’re going to use to suit your surgical wound with, you couldn’t just buy material at the sewing machine store. You’d have to use material that was approved for use in the human body. But once you have that device for suture material in your hand that’s now approved by the FDA for using in the body how the wound is sutured is determined by the surgeon who’s sewing the wound. It’s not the jurisdiction of the FDA. They do not govern medical procedures and they do not govern body parts.

So how the FDA delineated what they will govern is with a phrase called “minimal manipulation.” They just came out with these policies. You see that’s stated for immediate release November the 16th. So just last week, they came out with this and this is important news and it’s, I think should be encouraging news for most of us.

So comprehensive regenerative medicine policy framework. Now this gives a pathway for those of us who do skin cells to move forward. But the thing’s most [inaudible 00:03:32] procedures [inaudible 00:03:34] involve the Platelet Rich Plasma and we want to know what’s the FDA doing about this. Now they put on [inaudible 00:03:45] medicalassociation.org, which is our umbrella organization, and look in the recent post, you’ll see FDA physicians for Platelet Rich Plasma stem cells. So here, I have a video and some papers have already been out for quite a while about the FDA. Some of the research articles are up in [inaudible 00:04:04] journal talking about the difference. But I remember one time, the FDA considered regulating eggs so [inaudible 00:04:14] an egg was [inaudible 00:04:16] to be more than minimal manipulation and thankfully the gynecologist said and [inaudible 00:04:20] specialist said no, that’s not right. You shouldn’t be regulating eggs. So the point I’m making here is there’s a blurry line between what’s minimum manipulation and what isn’t.

Here is where I put a link to the most recent position paper. So when you click on that, you will land on this page and you can read the [inaudible 00:04:41]. But if you slide down to this page and click on this one right in your final guidelines for … Let me make sure I get this right. The same surgery procedure, exception, questions and answers regarding [inaudible 00:04:57], if you click on that, it takes you to this. This is where they talk about Platelet Rich Plasma. If you slide down, the exception I’m talking about is how do you decide what is an exception to the minimal manipulation. What do you have to do to it before it becomes a drug? If you slide down to number 13, they tell here “Platelet Rick Plasma and other blood products are not considered even in the ball game … ” You don’t even have to think about an exception because that’s your blood and so blood products, the FDA should, in my opinion be regulating some things. They should definitely be regulating the devices, in my opinion, that we use.

If you’re going to do something with blood and then put it back into someone’s person, that should be carefully regulated by the FDA. Those who might somehow want to make a homemade version of that without understanding what they’re doing or realize that you can spend a lot of money and have a laboratory that takes it to a higher level that most physicians have. But if just somehow you’re going to modify a laboratory kit and do things with mechanisms that were made to analyze blood and somehow just decide you’re going to do that and use it to put blood back into someone’s body, it’s just not good medicine. But assuming you’re using a FDA approved kit to prepare the Platelet Rich Plasma, here it is in black and white. Okay, the FDA considers that to be blood products and they are all hands off about that. So hopefully that answers that question.

Now a real quick marketing thing that you guys … Some of you’ve done and others have not. I’m going to type it into the chat box. If you go to [inaudible 00:07:03].com/cellmed, this is probably the best marketing tip I can give you. If you click on that link, it takes you here. [inaudible 00:07:17].com/cellmed.

Calendly.com

By the way, this is really, I think, nice software that anybody can set up on their own that allows you to schedule your appointments for your office even if they’re paid in advance. It allows you to schedule appointments before you even get paid and will integrate with your personal calendar so that’s your software tip for the day. If you put something on there, it looks on that before it decides if you’re free and you can set up all sorts of rules like if you’re going to be off on Wednesdays at three or whatever. So we can use this software to schedule with the [inaudible 00:07:55].

And right here, [inaudible 00:07:58] orientation, the people who fall out of our group and tell us that they are not seeing the phone calls, without exception, there are people who have not done this free [inaudible 00:08:12] where we spend an hour on the phone with you and your marketing person or your marketing person alone and we will do this as many times as you need to until you’re seeing results. It’s free. It’s part of being in the group.

Calendly.com/CellMed

No extra charge for it. We want to see you successful and we’ll give you a tour of the website. A lot of times, there’s tools on there. It goes marketing tools, pre-written notes and providers just can’t see it all. They get overwhelmed of all the emails I send them and just get confused.

So we have three full time people with business degrees in our office that have all been with me at least a year and they are not just experts at this business but they’re experts at how our providers are doing those and they’re just waiting and eager to help you because they know [inaudible 00:09:12]. We have more money for research, we have more money for supporting you guys, not just [inaudible 00:09:23] with marketing and supposed to help you educate your patient. So we’ll put in a plug for that.

Does PRP Cause Scarring?

Let’s go to some science real quick. So these are the questions that I’ve received a few times in the past week. Some of these comes in waves and this past week, I had a wave of questions about Platelet Rich Plasma causing scaring. I think sometimes things get out there on the internet and [inaudible 00:09:55] something on the blog or something, I don’t know what happens. I would think you would just to go pub med and search for scarring. I’ve done this multiple times over the years just to make sure that I’m not telling people wrong. I just put the link to that in the chat box. But obviously our first rule is “do no harm.” The truth is that we all hurt people and we don’t mean to but I had two people crash their car just driving to my office. People can’t get out the [inaudible 00:10:31] without getting hurt. They sure can’t go to the doctor’s office and the best of physicians hurt … We hurt people sometimes. But we want to as much as possible, of course, round down at night and know that we have not hurt people.

Platelet Rich Plasma for the Treatment of Scars<–

Research about Platelet Rich Plasma

So part of the beauty of Platelet Rich Plasma is [inaudible 00:10:50] and I’ve tried to keep up with this, if you hurt someone with Platelet Rich Plasma, if you do with Rich Plasma, you actually have an incredible case as the first case in medical history as best I can tell. So when it comes to scars, for some reason, occasionally laypeople worry that somehow the Platelet Rich Plasma’s going to cause scarring. This is a general thing to worry about because it causing tissue growth. So you might wonder as a physician even or weaker physician or a specialist, you might wonder will this cause scarring. I think it’s [inaudible 00:11:32] for you to see here and if you can quickly [inaudible 00:11:36] through, this is 50 papers that have been published. You can scan through these papers and what you’ll find is Platelet Rich Plasma treats scarring. You’ll see that it being used to be keloid and split face studies use to treat scarring from acne scars, pox scars, surgical scars. It remodels the [inaudible 00:11:55] to make it become more normal.

To a layperson, you could describe scarring as basically tissue that’s healed together, but it’s healed the way that the tissue no longer has a configuration. All of these studies, this is the first page. I think it’s three pages. So it goes on for three pages worth. All of these studies are demonstrating an improvement. There’s burn scars, laser treatment, adhesion scars. You can see that there are also improvement. You can’t prove [inaudible 00:12:37]. It’s easy to put the positive and the negative. What it can do is show you 50 papers that show that PRP help scarring. I’ll find one that shows that it causes scarring. So if someone finds it, show it to me.

But how does this relate to what we do? If you do a procedure, let’s say you do a O-Shot and someone says their pain is worse, what do you do with that? For example, one of our providers is actually on the call, and I’m going to unmute her mic later, told me she had a patient who had back pain after an O-Shot. But when she got the asking, the woman had after the O-Shot, she was so excited about it, she and her husband had [inaudible 00:13:25] sex and she had injured her back. So the point I’m making is that if you see a magic trick, if you see a [inaudible 00:13:33] or a magic show [inaudible 00:13:36] appears so what you know is that something you’re not something about that situation.

So when someone tells you that their pain worsened with Platelet Rich Plasma or their erection got worse, it means that there’s something happening that we’re not seeing because Platelet Rich Plasma does not damage tissue. So the case of the erection getting worse, as far as I know, the cases about resolved when the person quit using the pump. So it wasn’t the PRP. I was the overuse of the pump. If you hear that complaint after a [inaudible 00:14:15], have them to stop the pump for a couple of weeks and them maybe start it back every other day or half the pressure.

For the O-Shot, I occasionally hear that people’s orgasms go down. I wish we had more data though so my guess is probably one in 500 something but I do occasionally hear someone’s orgasms seem worse. I only know of one where it never occurred and I don’t have an explanation for that. But you can make an easy case for why it might happen in the beginning because we’re vaguely created artificial hematoma. What happens if you have a hematoma on your arm, the sensation is not as great in the beginning. So why do some people have hypersexuality and more sensation and others have less? I don’t have a good explanation. But that’s my best guess at what’s going on and why it usually revolves [inaudible 00:15:14] it resolves and then they recover, get it back to baseline, or most of the time better than baseline.

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So we have a consent form. We actually recently updated the consent forms. Our consent form’s always been strong but they used to always be more organized, more strengthened, and now we read part of this procedure. So you’ll see things listed that you’ve never seen. A long list of complaints and things that we’ve seen, we’ve added to the long list of complaints and we still include a line that says, “This is not a FDA procedure,” because some people still thinks the FDA approves procedures. So in the consent form, we say that it’s not. I’ll show the consent form list. So if you go into oshot.info and sign in … So when you get there, it’s going to look like this. I’m going to just pull it up really quickly. Then we’ll answer several more questions and then we have a [inaudible 00:16:25] promised to show you.

So you log in. This is the back side but when you log in, you’ll see something that looks like this. This is where I’m really begging you guys. The more the survey data we get, the more we’ll understand, I think, how often some of these things happen and what’s the [inaudible 00:16:44]. Once again here, you’ll see the legal when you go to legal. Our new consent form is there and this is me describing the routine, which I’ll get into now and how to use it. So there’s the consent form and we’ll just finish this out now as far as the scarring goes. As far as I know, saying that you damaged something with Platelet Rich Plasma is similar to saying that you have suffocated from oxygen because logically, it’s hard to understand since Platelet Rich Plasma remodels things back into a normal [inaudible 00:17:22].

But here’s the consent form and I’ll put up … You see it’s pretty straight forward and you can see there’s as long line of things. Basically, it just listed everything we could think of that a person complain of because do we say that PRP doesn’t cause fatigue. We haven’t done 10,000 people with a [inaudible 00:17:45]. But we do have almost 10,000 papers. Let me just pull this up again for you guys to realize. If you got to pub med and put in Platelet Rich Plasma, I think it’s interesting to see the body of knowledge. When I started doing this eight years ago, this used to be 5,000 personnel [inaudible 00:18:08] and just [inaudible 00:18:10] exploding.

So back to the video. There. So you can see we put the pen and we also put that we don’t really know. Something can happen we’re not anticipating. I can conservatively say that if you look at the number of people we have, the number of procedures we’re doing, we’re at 2,000 procedures by now easily, just O-Shots alone. The region company alone says [inaudible 00:18:44] PRP kits for a year so the number of procedures that PRP is phenomenal. Millions of procedures done yearly. Yet when you look at pub med, you cannot side one serious side effect. Not one serious thing that’s happened except recently when they had something bad happen in the eye. I can find the [inaudible 00:19:08] report [inaudible 00:19:09] mixed something weird with PRP [inaudible 00:19:13] and it got an infection. But you can’t blame it on the PRP. It sounds like some sort of home [inaudible 00:19:19] or something.

As far as the PRP procedure, [inaudible 00:19:24]. So when I show people this consent form, of course I sit with them and I tell them that these are things to go wrong and we don’t really know. We’ve done thousands of procedures and so [inaudible 00:19:38] at all. There it is. So that’s the consent form. Now back to this [inaudible 00:19:45]. Let’s say that someone does not get … David just put something here. Let’s see what he says.

Okay, so, here is me at one of our workshops talking about why I’ve given money back. As far as I know, anybody that I’ve ever seen since I went to cash procedures in 2003, I gave … [inaudible 00:20:22] PMD stats, so 15 years ago … You know as far as I know, anyone who was unhappy with a procedure that I did, I returned every penny that they gave me.

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People get nervous when I say that, but, most people are not dishonest. Yeah, people have stolen from me, people steal from me [inaudible 00:20:40] sure. I run my life … Although I don’t make it easy for people to steal from me, if I base my whole life on keeping people from stealing from me, it would not be a pleasant experience, and I would not be able to freely give as much, or offer as much. If people are mostly not … If they were mostly dishonest … If most people were dishonest, Walmart would be out of business in one week, because they have … Since opening, they had that 100% money back guarantee for anything you return.

Why I Give All Money Back ANYTIME ANYONE is not happy with the results…

Even when I did weight loss, and I would have 3 weight loss classes [inaudible 00:21:18] did a lot of weight loss there at one time. I had a guarantee that you could have every penny back you had [inaudible 00:21:28] doctor fees up to 365 days from starting the program. And once or twice a year someone would want all their money back, but, having that made me more careful about who I took care of. I didn’t want to take the reverse side of that equation, I was careful not to take money from people I didn’t think I could get well, but I would take money from some, and still do take money from people occasionally.

Here’s the interesting, other flip side of it, or aspect of it is that if you are ethical, and as far as I know everyone in my group is ethical, or I would have asked them to leave the group … But, I feel like we have a very ethical group, and if you are ethical, then you will sometimes hesitate to take care of people if you’re afraid it won’t work. But, if you have in your heart of hearts that you know you’re not going to keep their money if it doesn’t work, and your cost of goods is relatively small, so that you’re going to make your money back on the next procedure, then what happens is you are actually more willing to take care of the harder cases.

Just make sure you don’t care of all hard cases. Just mix it up so that you mostly take care of the easy cases that you know you can get well, and occasionally take care of people for free, as we all do, or take care of the hard cases when you know your likelihood of getting them well is less than 50%, but you have enough mark up on your cost of goods that you’ll still be profitable in the next procedure.

So, you can hear me talk more about that there if you just log in and go to Legal, and here’s the receipt that we use. And, again you can get your … This is sort of my disclaimer, so you should … My attorney requires me to say to you, I’m not your attorney and you should have your attorney look at this. But this is what we use in our office, and it’s very simple, just two lines.

So, when someone has an outcome that’s not what they wanted, then I tell them come in and Let’s talk about it. And I’m very sincere about that, and I try to see what else might help them. If it’s not something that I have to offer that would help them, then I say “I’m sorry that this didn’t work for you, and there’s no way I want to keep your money if you’re not happy with what happened here. So here, let me write you a cheque.”. And I write them a cheque for a full refund, every penny of it, and then I have them sign this. So it says “I’ve had no adverse consequences from the … Whatever procedure … On this date. Because I’m not realizing the benefit, subjective benefit, I’ve been offered and accepted a full refund of this many dollars on this date.”

They sign it, and my nurse signs it, and we’re done. And then everybody’s happy, they don’t feel like I ripped them off, and I’m not just giving them a receipt, as you can see, I’m making it so that we’re legally also clean from each other. And, I very ethically, put my full brain, and all of my volition into helping them find another alternative, because they would have not given me this money if they didn’t have legitimate [pain 00:24:45] that’s bothering them.

And by doing this, some people have this idea erroneously that if you return money it’s making you subjective to a lawsuit. Not so, again I’m not your attorney, but all the attorneys that specialize in med spas and medical care that I’ve spoken to say not so.

Any time you are doing your best to not harm people, whether it’s medically or monetarily, you are making yourself less likely to have litigation. I get a dirty letter or an email from someone who’s angry about one of our providers, in every case it will be that the provider … Not only did the person not have the outcome they wanted, it’s that they didn’t get their money back, and they feel like they were ripped off.

So make use of the receipt, it sits right here on the Legal page to be downloaded. And make sure that you do mostly a high likelihood of success procedures, which are listed on these recent post on the CMA, and our How To Do web pages.

So that’s the receipt. What else am I needing to cover. I think that’s the main things from [inaudible 00:26:09] the things [inaudible 00:26:11] by email. I have a few more questions, but let me handle some from you guys for a second. Let’s see. Actually, David let me … let me get to that in a second, because I have another question here that I want to cover.

So this one has to do with hair. I’ll just let you look at it. The question that was sent to me. So it says “Hi Charles, I’d like to pose the question for [open mic 00:26:43] discussion.”. By the way, this is a … If you cannot make one of the [open mic 00:26:46] discussions, this is the way … This is a nice way to send it. Just email it, I’ll cover it when we do the webinar, and then it gets recorded and transcribed. So “I’d like to pose a question, what’s the latest on adjuncts for treatment of hair loss with PRP?”

Treatment of Hair Loss

A couple years ago we were using [ACell 00:27:03], vitamin D, and vitamin B, and still this is the recommendation. So, the .. Of course, [Dr. Harrison 00:27:12] reads the research, you guys read the research. The question is am I hearing anything from the grapevine because I’m in the nice of position of being able to get email from all you guys, that are brilliant and out there working, and so it makes me switchboard, and I’m always taking notes.

What I can tell you is I am not hearing any great new recipes. Most people have dropped the [ACell 00:27:35] out of their recipe. Now if you go to our [inaudible 00:27:39] website, on the How To Do page, we have a recipe if you want to use it, from some of providers [inaudible 00:27:45] where they mix vitamin D, and B complex, and other things.

But the [ACell 00:27:51] bothers me because it’s an animal product. You know, it’s a pig bladder matrix. And I was in a research protocol where there was cross immunity to a small pox vaccine that was grown on cow … Cow pox, and we were testing a genetic [recombinate 00:28:10] version, and I had someone who showed up with a myocarditis from that cross-reactivity. And they eventually stopped the study, so who knows how many of us got myocarditis back in the day, when that was the way to vaccinate for small pox.

The point is that, I can tell you that there’s [inaudible 00:28:28] paper showing no side effects from using PRP. I can’t tell you that about [ACell 00:28:33]. I don’t like what it does to the possibility of something going wrong, and, I just don’t use it anymore.

So, I did pull up a couple of papers here, and I’ll just let you see some of them, to let you see … What’s … These are, I think, representative of many more. So, if you look at this … The word is out, is what I’m getting to, is that it does work, and people are mostly using it as a [inaudible 00:29:10]. The … As far as [inaudible 00:29:15]. They mix … They’re doing it in combination with laser for the hair, you know the laser caps. They’re doing it in combination with … With Minoxidil, or Finasteride, as you can see here.

But in this study, these are people who failed topical Minoxidil and Finasteride, and then they gave them PRP, and they had a response. So, in this group, they went 3 monthly sessions followed by 3 [inaudible 00:29:43] monthly sessions, and that’s what I usually see. Some … Once a month [inaudible 00:29:49] 3, and then every other month, then once every 6 months. It gets a little bit more variable after those first 3 treatments.

Here’s another paper. And again, so in micro … so instead of injecting, they’re doing micro-needling with PRP versus topical Minoxidil. So I get that question a lot. Should you micro-needle it or should you inject it subdermally, or what do you do with it? And I just do everything. I’d goes … I block it by doing a little ring block, which is on our website. And then I do subdermal and then micro-needle [inaudible 00:30:28] to play with the core on top. That’s how I do it. And when I see the people who come from the hair clinics [inaudible 00:30:32], that’s what I’m seeing them doing.

Platelet Rich Plasma Hair Protocol 1
Platelet Rich Plasma Hair Protocol 2
Platelet Rich Plasma Hair Protocol 3

Now those who are hair transplant surgeon, I heard lecture at one of the venues, said women are very responsive. He just treats them once and tells them to be patient. So I haven’t seen this study yet, that says that one treatment, the patients needs to wait six months to a year. I haven’t seen the study that shows one treatment and then wait a year versus a treatment … [inaudible 00:30:57] a lot of times three and wait a year.

So who knows who can do that. We’re over treating the need to do the next two. We just need to do one treatment, wait in women. But the common thing with women, that seems to work best that I’m seeing it do … subdermal injections, micro-needle on top, PRP on top of it, put them on 2% Rogaine, tell them to be patient. And yes, most people are doing that, followed by another treatment in [inaudible 00:31:26]another treatment after that. That’s what I’m hearing is the protocol and I don’t see any other magic mixtures. It’s still out there [inaudible 00:31:36]scalp studies and they’re showing nice results even for alopecia [inaudible 00:31:40] it works better than trying Tryptizol alone, so that’s for hair.Let’s see … Some of the websites had some questions too so let me get back to those.

So this one says, “Is it okay to use a laser light for treatment on patients who had a P-shot or hair restoration?”. I think that a topical laser light to help hair growth is of course something you could do starting immediately and that has been shown to help as a stand alone, and so, I haven’t seen it with PRP, with laser cap versus no laser cap but it will make sense that if either one of them works alone it might work better combined because this is not a heat treatment. It will be different if it were [inaudible 00:32:36]sort of laser like[inaudible 00:32:39]laser or pixel laser where you’re actually [inaudible 00:32:44] tissue like a [inaudible 00:32:45] with vagina, in that case you want the heat to go first followed by the PRP immediately and I would give at least four weeks before I do another PRP treatment or another laser treatment because you have to give … I think the pluripotent stem cells time to develop, and the soft tissue studies I see they seem to max out at about twelve weeks with most of the time eight weeks.

[inaudible 00:33:16]obviously studies that demonstrated that [inaudible 00:33:21]where with orthopedic procedures it’s a much longer time to maximal benefit with soft tissue I think you’ve achieve most of the benefit in eight weeks. Four weeks is the minimum amount of time that I would wait before I re-treated with laser because I think that’s undoing the progression of the benefit of PRP. So that’s that question. Let’s see what else we got.

Is Platelet Rich Plasma as Good as Platelet Rich Fibrin Matrix?

Got some more questions here.Okay, here is some. So this is a interesting question that I [inaudible 00:34:14] let’s do this one now. The question is ” Is there an advantage of platelet rich plasma over Platelet-rich fibrin matrix?”. And this to me a play on words or [inaudible 00:34:30] because everybody’s PRP turns into Platelet-rich fibrin matrix when it’s injected. Platelet-rich fibrin matrix is just the PRP growth factors con jelled into plasma and [inaudible 00:34:48] peptide chains that are in the[inaudible 00:34:53] are causing this [inaudible 00:34:53] to cause this matrix formation and that’s what causes the wound healing. But then some document out there that somehow that needs to be made in the syringe before it’s injected and the truth is that if [inaudible 00:35:07]in the tissue the inject PRP is exposed to collagen. The way I describe it to patients that’s the [inaudible 00:35:13]around the scab when you scrapped your knee, that’s what’s holding the tissue together when you’re healing a wound. Some people who sell kits that [inaudible 00:35:26] that matrix in the syringe seem to indicate that maybe that’s what needs to happen, I’m not so sure that’s the case.

The question then becomes, do you get adequate activation if you let it activate after you’ve injected and the platelets are exposed to collagen and then put in the matrix or do you leave it exposed to PRP and the collagen in the syringe and then inject it.[inaudible 00:35:55] has cure that comes with Calcium, so you’re activating the PRP before you [inaudible 00:35:58][inaudible 00:36:00]has cure that comes with HA that we can’t use here but it’s available in other places where there’s no FDA, where it comes with an HA which activates the PRP so you’re making the matrix before you inject it. Here we add calcium by the cals [inaudible 00:36:18] before we inject it and the ratio is .05[inaudible 00:36:23] 10 percent calcium chloride to [inaudible 00:36:28] of PRP or in other words divide the volume of PRP by [inaudible 00:36:32] and that [inaudible 00:36:32]volume of calcium chloride ten percent you should add.[inaudible 00:36:37] I do think you should[inaudible 00:36:43] you’ll get about, when you[inaudible 00:36:48] and you get closer to 100 percent activation if you add calcium chloride before you inject.So we’re activating [inaudible 00:36:55]substitution everything else we’re putting at 65 percent activation[inaudible 00:37:00] to that question is we are all making platelet-rich fibrin matrix anytime you use[inaudible 00:37:07] it’s just how you make it[inaudible 00:37:10].

Okay let’s see, we’re answered that one last time. Some of the videos [inaudible 00:37:23]behind the camera. Yeah that’s true, I’m sorry about that.[inaudible 00:37:29]I think if you look at the videos [inaudible 00:37:30] you can see everything by putting the videos together [inaudible 00:37:34]there’re sections of the videos[inaudible 00:37:40]and the truth is the people who come to our hands are [inaudible 00:37:43] do take it a different level. There’s something in particular you’re trying to see that aren’t available please let me know [inaudible 00:37:53]everything that’s build to be known by how to do it is there so if there’s something you’re not seeing tell me and I will shoot another video to take the place of the one the spot that you’re not seeing.Even though every second’s not visible every part is important about to do it should be visible. Okay so I think that’s all the questions on that one.

Let’s see, we may about to wind this down.We went through that one last time.We answered that one last time. Okay, I think that’s it let’s go through and see if you guys have question then we’ll shut this down. Let’s see Doctor [inaudible 00:38:33]has some prior questions.[inaudible 00:38:40]I’ll just let you have at it. Are you there?

An Orthopedist Talks About PRP

David: I’m here.

Charles Runels: Beautiful so, thank you for[inaudible 00:38:54]the interesting questions, tell us what you’re thinking and let’s just[inaudible 00:38:59] what is on your mind if that’s okay.

David: [inaudible 00:39:06]I wanted to tell you that[inaudible 00:39:18] my son with whom I’ve done PRP, came home with[inaudible 00:39:23]surgery for twelve years longer going through more [inaudible 00:39:29]

Charles Runels: Hey David, I’m hearing some really interesting stuff just breaking up a little bit and it sounds like a lot of experience to share with us,there anyway you can get closer to the mic or fix it where we can hear you a little better because it sounds like [crosstalk 00:39:49] this could be very valuable.

David: Let me open the[inaudible 00:39:52]in my computer and maybe that’s better. Can you hear me now-

Charles Runels: That’s better, whatever you just did made it way better. Maybe you could start over if you don’t mind.

David: Yes I had replaced my laptop so was using my other screen.So as I said, I’ve used my son and my wife as guinea pigs for PRP and stem cells recently, but I’ve had 12 years of orthopedic experience. Is that coming through over the email?

Charles Runels: It’s perfect now, and it’s very valuable. We’re interested in those 12 years of experience.

David: So I’ve got 12 years of experience of using bone marrow concentrate amniotic material, PRP in all forms and fashion from every vendor, and as you know, I recently converted from being a cutting surgeon to being a non-cutting surgeon and moved into the alternative realm. I recently got back to Tucson from the AMG meeting, so we kind of focused a lot on the cosmetic side as well as peptides.

Results of my son’s tennis elbow, he’s had five years of tennis elbow after Hurricane Rita and using a chain saw to cut down two trees in his backyard, and came to me and said, “Dad, can’t you possibly un-retire enough to operate on my elbows?” I said, “No [inaudible 00:41:09].” I said to Austin, “I’m gonna inject ya in my clinic with this new PRP I’ve got. We’ll see what happens.” Well, in five months, he called me, and I won’t use the profanity, but he says, “You got a blanking cure for this. You need to advertise it. [inaudible 00:41:22].” I used your technique and just used it on his elbows.

One thing he did tell me, he says, “That hurt like hell.” He said, “I can’t recommend it to anybody unless you find a way to make it not hurt so bad.” We’re looking into nitrous oxide, we’re looking into topicals a little bit more, and whatever. I just don’t want to interfere with the [inaudible 00:41:45] of the platelets, so any suggestion you might have on that, that you can publish for us it can help us be humane would be good, his orthopedist worked on a [inaudible 00:41:55] and we don’t care too much, but I think it’s better for the cosmetic world for us not to hurt people.

Charles Runels: Yeah, sure. Well that’s a lot of … keeping going because in 12 years you’ve got more to share than that, keep going.

David: I don’t want to burn up the hour, but the …

Charles Runels: No, no it’s good. I’m through with all the questions, I want to learn from you.

David: Well, I also reported on my wife’s recent O-Shot and that she did unbelievably well for ten days and no leakage whatsoever, we’re married 46 years, two kids, a 45-year-old, a 34-year-old and we’re physiologically young, but she’s had some incompetence, she’s got a [inaudible 00:42:36] some other things, that I said, “Look we need to try this, this isn’t so much for orgasm and libido, it’s for your … whatever, I wanna find out what happens.

She was dry for ten days, with no problem with jogging and trampoline and everything else, which was a big change. And then she kind of had a regression back. She says, “You know I think I may be actually leaking more now after ten days.” So I kind of just [inaudible 00:43:03], sometime I don’t much, whenever I get it back a little bit, just wait. And I ask her finally and I said, “So are you still leaking?” And she says, “You know I’m not.” And so I think as you said before you got to look other places for problems sometimes [inaudible 00:43:24] we’re so used to in medicine, the most critical people around for our own selves.

Charles Runels: Let me see if I can explain, again we need the ultrasound studies to prove this. We have two … excuse me, we have three now [inaudible 00:43:38] radiologists in our group and hopefully they’ll do these studies for us, but here’s what I think you just described. So if you think about it when you do the procedure, you obviously, there’s no time for cell growth you get those [inaudible 00:43:56] and all that. My best explantation for what I have … resolution of confidence immediately, which doesn’t happen to everybody, but happens a lot is that we are forming that [inaudible 00:44:10] matrix and it’s acting like liquid sling and stopping the [inaudible 00:44:15] immediately.

Of course, that’s like what happens to the scab on someones knee, this is what I explain to patients, you know it could go away immediately but it may not, which is making the hematoma, and [inaudible 00:44:28] resolves though, the actual tissue growth doesn’t really start until at least when you’re doing cosmetic work, you can’t see that much until around the third week with like at 12 week.

So what could’ve been is that the matrix was there, stopped it, which is great and I love when that happens even though it sometimes [inaudible 00:44:48] it tells you, you put it in the right place. But then it could go away and when it came back that’s the true cell growth. Now the other thing that just to add to your story and again, I’m making this up, I think this is probably the right thing based on what I’m seeing and about the science of it, I could be wrong and I’m the last person to say everything I’m telling you is right. We need to do the research to figure it out, but your story you just told is very common.

The other thing that’s common is that sometimes it will go away, but sometimes it’s just better, but it’s not all the way gone in that [inaudible 00:45:27] and when that happens just repeat it, it’s so common for it to be better after the second shot even the sex part, sometimes the urine gets better and the sex isn’t better after shot two or three. It’s so common I’ve even thought about just making it a standard protocol that everybody gets two shots because, that to me seems unfair since many women would be improved or as well as they need to be and are, most of them actually around 60 percent last time I surveyed, 60 to 70, depending on the problem.

And then it jumps to 80 to 90 plus after the second one. So it kind of seems unfair those people, the 60 to 70 percent to require a second shot or make them pay for a second shot and may not need it. So having said all that I think that’s my best bet about what happened with your wife, I just wanted to throw it in, but keep going with your experience … we want you to teach us, because here’s the thing the [inaudible 00:46:23] were ahead of us with the PRP and if you’ve been doing it that long you have other things to teach us, so go for it.

David: Well I can tell ya I probably started doing these alternative methods with [inaudible 00:46:33] this and I still … up till February last year [inaudible 00:46:37] this trauma. I mainly, sports, but a lot of trauma. I never had another non union [inaudible 00:46:46] fracture after putting PRP or [inaudible 00:46:49] or bone marrow concentrate in those fractures. It was very, very helpful also with skin cut bridge [inaudible 00:47:00] skin loss and muscle loss, that helped tremendously. What got me to that comment was if you do, do a second one, do you fully or do you charge a reduced price? Or do you give it to them, how do you handle it?

Charles Runels: Okay, so that’s a good business question. I don’t like to tell people, well this is the standard thing that everyone should do, because you’re the one looking at your patients. But I’ll tell you what works for me with most of my patients, if they have a nice result, their [inaudible 00:47:41] is mostly gone and they’re happy with it, but they think, I think it would, I may want another one, most of those people want to pay you again, they realize that it worked, they just want to see if it works better. They want to pay you and so they should, let them. If you want more, you should pay me again. But, I would insist on it if they’re attitude or their, if my feeling about them, their communication to me … it’s not [inaudible 00:48:16] that they feel like they go their value for their money, then I’ll do the next one for free.

[inaudible 00:48:24] it’s not a four hour procedure, it’s fairly quick and our cost of goods are reasonable enough that you’re still profitable, so that’s where I am on a case by case basis. [crosstalk 00:48:38]

Don’t make that decision until it’s been at least eight weeks. And really chances are that they may get better at 12 to 16 weeks if they’re not better at eight, still kind of pushing it. To me it feels kinds of, maybe not so far to them to make, 16 weeks that four months. So do I really want to make them wait for a third of a year before I decide if I’m going to retreat it when they’re leaking down their leg, knowing if I retreat it, it may go away and so it’s sort of judgment call, but one things for sure I would make them wait at least eight weeks because I might need to subject them to another procedure or draw their blood and all the things that go with it and whether their paying me or not there’s some cost of goods and some time involved, break times valuable too. So I would tend to wait at least eight weeks before [inaudible 00:49:34] did work.

David: Excellent, with respect to, to my bias coming from orthopedics and coming from PRP and moving into bone marrow and [inaudible 00:49:44] back into [inaudible 00:49:46] and PRP I think I consider I can say pretty … opinionated that stem cells in some form of fashion, I call it stem cell signaling, just so we don’t get [inaudible 00:50:04] with our big brother but the signaling factors and growth factors that come out of stem cell in my opinion are probably big brother and PRP his little brother and we know that there could be 600 drug factors in the stem cells, PRP or bone marrow and there’s probably 300 drug factors in PRP so maybe it’s not that big of deal, pretty even. In somebody that’s a little bit more aggressive, for example my wife had Hallus Rigidus, which is loss of the cartilage in the metatarsophalangeal above the big toes and ready for either fusion osteotomy to remove the cartilage around or arthoplasty and she was on the surgery this time last year, I chose to go forward [inaudible 00:50:55] as a guinea pig my first case after getting back to California and studying lipogenic stem cells and I injected both of her big toes.

The chronology of that is that four and a half months of bated breath she got me and says, “I think my right toe is better, and if I’m not.” She says, “My right toe is definitely better and my left toe is better.” I know exactly when I did this, because I did it a week before the election a year ago and she is now admittedly, somewhere around 75 to 85 percent better in the bad toe and 95 percent better in the good toe and she is extremely happy, I don’t have any claims about regrowing cartilage or anything like that. All I know is symptomatically she can wear high heels and boots and she can jog the hills in Austin, Texas and she can go into yoga where as she could not pull forward, she was putting [inaudible 00:51:52] and everything else on her big toe four times a day and she was miserable. She grabbed me by the throat she said, “Look you’re supposed to be smart, do something.”[crosstalk 00:52:01]

Charles Runels: Obviously that’s anecdotal, but it’s traumatic. It’s not just anecdotal, because you know better than I having been in the ortho world. There’s hundreds of papers, probably thousands of papers in the orthopedic literature backing up exactly what you just said, so it’s not like you’re just pulling that one out of your hat.

David: [crosstalk 00:52:31]It’s really about [inaudible 00:52:32] fractures.

Charles Runels: Along those same lines, I know that most of the people on this call, many of them do treat orthopedic cases, most do not but what you’re saying is very relevant because it all has to do with tissue healing and thinking [inaudible 00:52:47] timeframes and what’s possible and what isn’t and that’s why I’m bringing up this picture that many of you guys have seen before. This from that, which is fairly extensive hypertrophic scar from Cortisone that had been there for a year to this a year later and it still looks like that seven years later, this was six years later, I did this in 2011.

This Juvederm with PRP with no stem cell transfer just recruitment of stem cells from PRP, from the Juvederm as a matrix on which to build the new growth. So if this is going on when we do O-Shots and P-Shots and faces then obviously … and it should be. There’s some intelligence about the process that’s beyond our skillset as far as what we’re actually doing with that needle.

And the other thing you brought up about the malunion … horrific thing that happens sometimes. I had to cases that came to me when I used to do clinical trials with [inaudible 00:53:58] from one woman who had been operated on six times they were considering an amputation, operate six times on her shoulder. They just couldn’t get her humerus to heal and she had an IGF-1 that was less than 60, it was almost in the dirt. She literally out of desperation, because someone told her to come see me and then I had another case with a woman who had an external fixator that had been operated on three times and in the process of doing that research [inaudible 00:54:38] stem testing for growth hormone deficiency, which you know is measured by a [inaudible 00:54:43] which is one of the well factors in PRP. That’s released by the [inaudible 00:54:48]. In both of those cases I put them on six weeks of growth hormone replacement, got their [inaudible 00:54:56] back to normal sent them back to the surgeon. And it’s anecdotal, but in both of these cases the next surgery went well.

David: That’s awesome. My last little caveat and then we’ll stop, which has to do with the recent, it’s recent in the U.S. but not recent worldwide is peptides and we’re dealing with peptides in our PRP and in our stem cells but there are peptides now that can be used in conjunction with what we’re doing to target specific formalities that we’re treating generically with our PRP, which is good but there might even be better results we can send a messenger, via a 15 amino acid of peptide that’s in conjunction with some of these cells and [inaudible 00:55:49], because I am pursuing this like a mad dog right now academically to learn more about it. I’ve got about 25 or 30 years between my masters degree and all that stuff is old and there’s a big gap in my knowledge. But I’m gathering as much as I can, as quickly as I can so I can see where this fits.

Charles Runels: Let me add to that as well because when you [inaudible 00:56:13] it other people think that, not the people on this call, but the people we speak to, our patients think, oh peptides this sounds like something you put in their cream. Well insulins a peptide, [inaudible 00:56:25] a peptide, it’s why we have to have an injection, we can’t take it by mouth, because we would digest it. Where we can take estrogen by mouth, because it’s a [inaudible 00:56:35] hormone and it’s not broken apart by the acid in the stomach. Of course everybody on this call knows that, I just want to point out as you did. There are hundreds of peptide proteins made by the pituitary glands, so when we say peptides it’s not some second rate little “hokie” thing. We’re talking about powerful, hormone like messengers that attach to cells and tell them to do remarkable things and the idea that you can have that [inaudible 00:57:05] already there, packaged up for you in the perfect combination in those platelets is pretty remarkable. We don’t have, it’d be nice to know, which ones do what and understand it the way we do things like growth hormone and [inaudible 00:57:24] and insulin, but if we can make it work why are we trying to figure out which ones are doing what.

I just want to put in my hooray for peptides and we emphasize this is not second rate stuff, this is powerful stuff and it’s what we’re doing when we’re using PRP. The hours up, thank you very much Dr. [inaudible 00:57:48] I’m gonna see if anyone else has a question, if not we’re going to shut this down. I don’t see anything else, so. Thank you guys for showing up, I’ll post this video with a transcript, it will be up in a couple of days, well may be Monday with the Thanksgiving holiday. Thank you for [inaudible 00:58:05] and I think we’re really doing some good things for the planet. You guys have a Happy Thanksgiving.

Section 5 of 5 [00:40:00 – 00:58:16]

Cellular Medicine Association
1-888-920-5311

FDA Positions on PRP & Stem Cells & Approval of Procedures

Here’s a summary of the FDA regulations concerning PRP…

Here’s a nice summary article with wonderful references…
click<–

Here’s an abstract summary of the above article…
click<–

Here’s where the FDA plainly says that PRP is not under consideration for regulation..
click<–

and here’s the most recent position papers<–

New England Journal Article about Stem Cells…
click <–

Training for physicians…
Urogynecological (click) <–
Men-Urological (click) <–
Facial Aesthetics (click) <–

Q&A.The “Capture & Heal” form, treating acne scars, treating dyspareunia, our current research…

Next Workshops with Live Models<–
International Society for the Study of Women’s Sexual Health (ISSWSH)
Cellular  Medicine Association

Transcript

I’m just back from an ISSWSH meeting, which I highly recommend that you guys do if you haven’t been yet. Here’s their website for the Fall course. Maybe once every year or two I recommend. You can see the content is pretty amazing. These are the handouts that they had. I thought I would just run through some of the highlights of the lecture that Andrew Goldstein gave on dyspareunia.

Dyspareunia

Dyspareunia, as you guys know, to a gynecologist, it’s like saying back pain to a orthopedic surgeon or an internist—the etiologies are so numerous that it’s almost the name of a symptom not a diagnosis. Although there was an article, an editorial, in the Green Journal Obstetrics and Gynecology about three years ago now where the editor said, “We’re not treating it as well as we can, and often times it really does go undiagnosed.” But even with that being the case, it’s worth looking at in more detail, the different diagnoses/etiologies

I’m going to unmute your mic, Kathleen, because I know you’ve been to this meeting (ISSWSH). You are going to have things to say about it. It would be very helpful to talk about it, I think. I don’t know if you’re able to talk. Can you hear me, Kathleen?

Kathleen Posey: Yeah, I can hear you. Can you hear me?

Charles Runels: Yep. We’re recording this because even though not so many compared to speaking, not a huge percentage of our people make it to the call, usually it’s in the neighborhood of 20 or 30 people out of over 1,000 people, I think it’s really worth thinking about pain/dyspareunia.

The good news is that often times when we have pain and it’s not easily diagnosed, our O-Shot® procedure seems to be working. Whether it’s healing damaged tissue or if it’s causing a decrease in inflammation like it does with lichen, I don’t know. But I thought we’d run through these known causes. I don’t pretend to be giving this presentation the way Andrew Goldstein gives it, but I’ll hit the headlights, the highlights. Hopefully, you guys can hear the lecture for yourself sometime in the next year or so.

This is the textbook that he helped edit about dyspareunia, which I highly recommend that you go through this. Eventually, I think there will be a chapter about an O-Shot. You can find this on Amazon.

This is the one, the version that he wrote for patients.

These are the known causes [see video]. Talk about this for a second, Kathleen. What on here do you see us helping with? Obviously, we wouldn’t try to treat fibroids with an O-Shot, but talk about this list for a second, and just the diagnosis of dyspareunia in general. Can you see it?

Kathleen Posey: Yeah, I can see it. I basically put PRP wherever the pain is. I map it out. I rule out the things like yeast infections, chlamydia, endometriosis, PID. I treat them just like we would treat those, but usually when there’s no reason, I just get out that Q-tip or just my index finger and say, “Where’s the pain? Does it hurt here?” Then I put the PRP.

Actually, a case I talked about a couple weeks ago was a anal cancer in a 40 year old that had radiation and complained of menopause and decreased lubrication. She went to a plastic surgeon who did Thermi-va on her, which only made her small vagina smaller. But mainly the pain was a posterior fourchette. I did put the PRP and did an O-Shot® because I do both. About two to three weeks later, her pain got better. That’s my method.

You can look at all these diagnoses. We know how to treat most of these things, but it’s the unknown ideology of the pain that I think the PRP helps. It doesn’t always. I had a classic vulvodynia around Hart’s line that was real painful, and she really didn’t respond that well, but that’s just one out of the many that I’ve treated. I’ll still try it on another patient like that, too. I wouldn’t limit it to that.

Charles Runels: Beautiful. Let me add to what you just said.

First of all, I agree. Most of the people, by the time they get to us for an O-Shot®, the patient’s already, before they are willing to pay cash, they’ve already been to other physicians and had lots of tests done. The good is that most of these things, if they were there, have already been treated.

The other thing I would add, which I know you do this, Kathleen. I know you treat some people for free, as do I, and that we’re both careful not to keep money if people don’t get well. I highly, highly recommend that everyone do that. If you’re treating pain and someone doesn’t get well and you keep their money, they feel like we stole from them. Even though we’re not used to giving back copays or whatever, insurance doesn’t refund money if we don’t … Obviously, we know we can’t get everyone well, highly recommend that if you treat someone for pain, and they don’t get well, either repeat it or refund their money.

By the way, the reason I’m talking to Dr. Posey for those of you that don’t know, you’ve been involved with the group right now for quite a few years. She’s been teaching it to other gynecologists. She’s a gynecologist, board certified, out of the New Orleans area, who has recently presented some research where she treated lichen sclerosis with a combination of surgical procedures and PRP, and teaches that method. A lot of experience seeing many thousands of women over the years as gynecologist and very well-trained, busy surgeon in the day. Back in the day, I know you were a high … Anyway, lots of experience.

Back to this list. Back to the list. The endometriosis, obviously, you wouldn’t treat it. The psychological, that hopefully is going to be teased out with your conversation. I wouldn’t try to treat psychological, obviously, with PRP. But let’s get to some of these pictures, though, because I think a lot of our providers don’t really know what to look for. I know that you’ve seen quite a few people who are being followed by a gynecologist-

Charles Runels: Some of these women, saw gynecologists who never diagnosed the pathology the gyn just went for the pap smear and never stopped to look at what was going on.

You just mentioned … This, by the way, is his algorithm for pain. I don’t show this, obviously, expecting anybody to memorize this whole thing from my overview here, but I just want people to realize there’s some thought that goes into figuring out pain. They’re not just willy-nilly treating someone without making sure that someone, if they’re not a gynecologist or a dermatologist, that someone hasn’t thought through a differential diagnosis … If there’s a rash for example, it should be biopsied. Someone should be thinking about that.

This first one is a big one. There is a pain disorder that’s associated with low testosterone. This is stressed over and over when I talk to people who treat a lot of vaginal and vulvar pain. The vagina and the vulva needs testosterone to stay healthy, and there’s a actual syndrome associated with pain and birth control pills, which almost always drops testosterone levels. Some women are susceptible to that, and some are not, but that’s something to think about.

This vestibulodynia of different ideologies is a whole subject in itself, but interestingly, I did meet a woman at this last ISSWSH meeting who had a woman with long standing vestibulodynia that was of this [neuroproliperative 00:09:01] type that responded to our PRP. Somehow it decreased that inflammatory whatever makes things go on here. This is a whole area for research that we need to take up, talk about. But obviously this is not a healthy looking vestibule. When you have this erythema around Hart’s line, then it’s worth thinking about testosterone creams. I think it’s worth trying our PRP as a way to modulate that.

Again, I’m just skimming through this just so you can see this should be thought about. This is that Hart’s line that you just heard Dr. Posey talk about that one. That’s inflamed, and this responded to using testosterone and estrogen creams.

Our O-Shot® is not the cure all, end all, be all, but I think it’s an extra tool that can be used in the thoughtful treatment of these problems, so I just-

I just wanted people to get a look at what some of this neuroproliferative. Vestibulodynia is a horrible problem. Basically, someone stays inflamed to the point that then if the inflammatory agent is removed they still stay inflamed.

A lot of times, they’re treated with creams that have some sort of propylene glycol or paraben in it that causes the inflammation. You’ve got inflammation, you treat it with a cream that actually causes a chronic inflammation to the point that when it stops, sometimes they’re left with a continued process that turns into this.

I think that was the main thing. The other thing to think about is here’s the pelvic floor muscles. Normally, these have been treated historically by palpating, as you heard Dr. Posey talk about, palpating and finding the place where a person’s tender, just like you would look for trigger points in a tender back and in the same way that physiatrists are now injecting PRP to treat this.

When you find that tenderness, you can now inject PRP. That will usually hurt worse for about a week and then it goes away. You have anything to add to these pelvic floor injections?

Kathleen: Not really. I’ve never really done them. I refer to pelvic floor PT, but I will say that even of the lichen sclerosus patients I’ve seen, a lot of them have pelvic floor dysfunction. You just touch them and their levator ani muscle just almost goes into spasm. It’s interesting, a lot of women when they’re touched, they wanna squeeze that butt together and I’m telling them, “Look, put your butt down into the table.” There’s a lot of comorbidity there with vulvar pain and then these muscles getting involved is what I see.

Charles Runels: Just to add to that, we do have people in our group who work with the pelvic floor therapists. I know you have them in New Orleans. Our little town doesn’t have one. But that’s a good referral source. One of our people actually had a pelvic floor therapist put a satellite office in their office actually they had a good working relationship [inaudible 00:12:30]. His O-Shot helps her therapy work better. That’s worth looking into.

The way that he established that relationship is he just had her bring one of her patients over and he treated the patient with the therapist in the room so she could see what was involved. Then she went back and did this therapy as she normally would and had a nice result. It’s a way both to help their therapies work better and to help everybody’s business. Let’s see.

Kathleen: At the conference in Boston, they talked about putting Valium in the vagina.

Charles Runels: They did.

Kathleen: Did they talk about that at all?

Charles Runels: They did. It didn’t seem to be as helpful, at least the feeling I got from the lectures, as using Botox. That was something that was talked about.

We don’t have the research showing that our PRP works with pelvic floor trigger points, but it should apply, since that research has been done in the physiatry literature with back pain.

They did talk at ISSWAH about trigger point injections of Botox and they mention diazepam and suppositories, but Botox seemed to be the first choice on the menu (before diazepam).

100 units is what they talked about using, which would be one bottle of cosmetic Botox. Some are doing it under anesthesia. I know Andrew Goldstein was saying he likes to use it without general anesthesia so he can tell better about where to put it.

Let’s see. I think that was the main thing I wanted people to see was just that. Oh, yeah. He does a vulvar vestibulectomy but he says he does a whole lot less of these than he did in the beginning of his career when people were not using testosterone creams.

It was really talked about a lot, especially in someone who’s on birth control and how common it is that that gets dropped in people who develop these pain syndromes, not just this vestibulitis pain syndrome. But this is a last resort, obviously, but it’s something that’s done just to know what’s out there. It can be done if somebody develops this pain that just won’t go away.

I think that we’ll find that there’ll at least be a subset of these people that get better with our O-Shot. We’ll see. I think that was the main thing I wanted to show. I don’t feel like it’s my place to just put all this stuff out since it’s their intellectual property, but I just wanted people to see that there’s a lot of stuff out there and it’s worth, I think, attending one of their meetings. It’s called ISSWSH, International Society for the Study of Women’s Sexual Health. Maybe go there once every couple of years and get a good update.

Amnion with the Priapus Shot® Procedure

Okay. We didn’t have as many questions this week as we normally do. We had one question that showed up on the Priapus shot website about has anyone used PRP combined with amnion with the Priapus shot. Some of us have, but I don’t think I have enough experience yet to tell you that it’s working better. I think it would be worth trying if someone didn’t respond and you were treated Peyronie’s disease especially if you’re trying to heal scar tissue, or someone just wanted to get the best that you knew to do.

Again, amnion is not stem cells, it’s where you’re harvesting the proteins from the amniotic membrane and then they gamma-radiate it. There’s nothing living in there. You just have the cellular proteins, the amino acid peptide chains that code for wound healing. That research has been done. I think just as a general help, I always like to add in a couple things that have to do with marketing and something to do with business.

Press. Men’s Health

We got a really big hit that’s worth talking about when it comes to the Priapus Shot® procedure. If any of you guys are doing this, it’s worth talking about. Dr. Gaines is in our group and he popularized the Gains Wave™, which is combining the Priapus Shot® with shockwave therapy.

You can see the guy in the Men’s Health article talks about the Priapus Shot® itself, or the P-Shot®, and it’s a very complimentary article, somewhat sensational, but he’s an entertainer. This is “Men’s Health,” this is not “The New England Journal.”

Obviously, we don’t make claims we can’t fulfill and you want to have a consent form and make sure that your explanation is not the same as “Men’s Health” magazine, but Lord knows we get huge amounts of negative press that’s absolutely uninformed and factually wrong. Someone wants to make this a little bit entertaining by talking about his penis he claims was 10 inches when he put it in the pump, I don’t know, maybe it was 10 inches. Who knows? But I’m not one to dispute him.

It’s a nice article that at least can start the conversation and maybe lead to you helping some people who need your help for their erectile dysfunction. That article’s there if you just Google “Priapus shot in Men’s Health.” Some of us are combining the shockwave therapy when people want it. Just so you know, if you look on our director, PriapusShot.com/members/directory, I added a logo so that if you’re using shockwave therapy people can find you.

Also, I know Dr. Posey uses the- That right there, that’s our shockwave logo.

Our Directory and Helping People Find You

If you are doing shockwave therapy and want the logo by your name, let me know and I’ll add it.

If you go to the O-Shot® directory, we have a logo now if you’re doing radio frequency. I think what’s gonna happen is as the research becomes more available, as we do more research, then people are going to want different flavors of our procedure based on their problem. I know there are some things that one of these machines, like Dr. Posey just mentioned, someone who had dyspareunia had a small, constricted introitus, that’s not the place to use your radio frequency device.

But you can see I added this. This is what I added, Kathleen, to indicate you’re doing radio frequency. If you want one of those by your name, just send it to support. I’m gonna put it in here…

support@vampiremarketing.zendesk.com.

I just put it in the chat box. You just send that and let us know and we’ll put the little thing. This means you’re treating lichen, this means you’ve put five people in our research project or a survey, this means that you’re using radio frequency device, and we have one for laser’s too. I need to update.

This is the legend so that whomever’s using this directory knows what these little symbols mean. I just added this last week, so I need to add that to the legend so that people know that means you have Thermi-O or radio frequency device.

So, let’s see Dr. Desmond Ebanks just put something in the chat box. So, the automatic pump he uses, I don’t, the guy talks about this pump like it’s the bomb. Who knows if that’s part of his journalistic license, but he talks about this pump as being a pretty intelligent thing, so I’ll ask Dr. Gains what brand of pump they’re using.

Let’s see whats the other question…
which shockwave device do you recommend? As far as the shockwave device, what I have right now is the E-Vive. There are others out there, I think they’re all made by, or most of the main brands are made by the same company. They’re kinda re-branded, depending on who’s selling it. So I think a lot of it comes down to who you want to work with. And who’s having a good deal, and good support. But right now, I have the E-Vive, which is the one Eclipse sells, in my office.

Treating Acne

Let’s see, Dana Kirk just said here, okay, so here’s the question from Dana. She says, “Often the Vampire Facial®’s being administered for acne scarring often have some leftovers. Anyone injecting into the larger pock marks? If so, is it worth activating?”

Ok, so this is a good question about acne. When I treat acne, I use micro-needling. But two tips on that….

First of all, if it’s in their budget to do Juvederm. If you think about what happens to the divet, or say the divets in say a basketball, if you put more air in it? The divets become more shallow, just from expanding the ball. So even before you treat the pocks marks, or treat the acne scars, if you’ll use some Juvederm, if they can tolerate it, as in, do they have any room for some improvement in the cheeks, and if it’s a female, almost always they do, unless they’re obese, they’ll have some. You can add to their cheeks and things look better. And the acne scars are already smaller (before you actually treat them). At least the ones in the cheek area.

Then, micro-needle with PRP (Vampire Facial®), but also go intra-dermal and sub-dermal with your PRP, subsize/undermine the scar, just like you would if you were treating acne scars before we had the Vampire Facial®, so taking the bevel of your needle and sub-sizing the scar releases it some. I

Inject a little PRP sub-dermally, inject some intra-dermally, and then micro-needle on top of it. Intra-dermally as in blanching the skin.

And all those combined will get a really nice result. Usually I treat them every six weeks for three treatments, and they love it.

As far as activating it for the face, I usually don’t (I used to do so). Because I don’t think it adds to it enough to warrant the extra pain. In the face. But I do activate the PRP in the O-Shot®, the P-Shot®, and for loss of sensation in the breast.

The Order to Do Shock Wave, Radiofrequency, & O-Shot® or P-Shot®

So Sherry, I don’t see your question, it just says … maybe you can type it again. Okay, wait, here it is… “Does it matter which order you do the p shot, the shockwave therapy, and did the p shot … okay….”

So, the way I think about the energy, whether it’s shockwave, laser, or radio frequency, the way I’m thinking about it is, if you’ve ever used, say, insulin or growth hormone, if you just take, if you buy Omnitrope or a growth hormone, or Genitropin, whatever brand. These are small amino acid or peptide chains. It will tell you not to shake, to gently stir when you put the water in. Just shaking the vial, it mechanically shears the amino acid protein chains, so it’s like taking the words of the sentence and just chopping them up and turning them into letters. And now that amino acid chain no longer acts as a small peptide signal. Right? So these amino acid chains act as signals that plug in to receptors on the cell, and that’s how growth hormone, that’s how insulin, it’s how all those amino acid chains work.

Over 200 made by the pituitary gland that we know about. Peptide chain signals. So, imagine if you did that, I have no research to back this up, but imagine if you injected a peptide chain, and then now you hit it with shockwaves. In the same way, imagine what happens to an egg when you put it in a skillet and fry it. Obviously those peptides or those proteins are being changed.

So the bottom line is, I like to use the energy, whether it’s shockwaves, lasers, radio frequency, whatever it is. Use that on the tissue first. And then immediately afterwards, same visit, then apply your PRP. Now if you want to, if you did the shockwave yesterday, or last week, or three weeks ago, or a month ago, and you wanted to do PRP after that, that’s fine, you’re not hurting anything. And if you want to, if you did the PRP three weeks ago and now you want to add the energy, you can. But in my opinion, as soon as you add the energy, you are probably shutting down whatever growth was taking place, from the PRP that you put. So it’s like you’re stopping, it’d be like you just watered a seed, the stem cells are [inaudible 00:25:26] stem cells that you just put there. And now if you’re trying to generate more growth by damaging tissue, now you’re crushing the little sprout or whatever tissue is growing. You’re crushing it or injuring it, in my opinion, if you didn’t do the shockwave therapy before it has a chance to mature.

So I would try to do them back-to-back on the same visit. And not do anything else mechanical to disturb the growth of the pluripotent stem cells until at least six weeks out, maybe even eight. To give what you did a chance to work.

So if you did the P-Shot® three weeks ago, yeah, you could do the shockwave now, but you’d probably be stopping whatever further benefit might have occurred from that original P-Shot®. It might be better to give it at least another three weeks before you did the shockwave therapy.

How Your Losing the Chance to Take Care of at Least 30% of the People who Visit Your Website…

Okay. Let me give you guys, I don’t see any other questions that are up. I want to give you guys one quick marketing tip, and then unless somebody has another question, we’ll shut it down.

This one has to do with when people get to your website. It is something you can ask your web designer for. This is my old internal medicine website. And this is just a form and here’s the scenario that will happen. And this is why this form is so important. You don’t have to make it, I just want you to know it exists, and this is a ten minute job for your marketing person. And if you don’t have one of these, you’re losing about at least 30 to 40% of the traffic that you could be getting to call your office.

So let’s say that you’re in, let’s say that you’re, you do an o shot, or you do a vampire, or you just do a pap smear on someone. And they go back home, and they go to Thanksgiving dinner. And they tell their mother, sister, friend, cousin, whatever, how wonderful you are. And they say, oh, what’s their name. And they say, oh, it’s Dr. Posey.

So now they take out their cell phone, or they remember the name and tomorrow, day after Thanksgiving, they google you. And they wind up on your website. If all you have is stuff for them to read, they read it and they go away. And there’s very good chance that a week from now, they’re not thinking about you. It’s all done. They will never become your patient.

If you put something on here that they can have for free, that costs you nothing, not a free consult, it’s gotta be something that costs you nothing. If you put something on here that they can have for free, and we’ve all done this before, that’s worth something to them, but costs you nothing, somewhere between ten and 30 percent of the people who land there will do that.

And then, now you have their email address. They start getting your newsletter, and a certain percentage of those will eventually become your patients. So it gives you a chance- this is not the main way you get your patients. Most of your patients are gonna be word of mouth, or someone googling you. But this plugs the hole, and it will increase the number of people you have by about 20 to 30 percent, that come in through your website, by capturing those people who would have never called you, had you not created this form.

And the way you ask for it, is you decide something you’re going to give away, first of all. It could be, and I, it should be a podcast or an email, or downloadable book. It doesn’t even have to be your podcast. What I’m giving away here is a podcast where I’ve just recorded for an hour the benefits of walking. So it says, number one weight loss melt secret, free immediate download. So that takes them, you ask them for the first name and email address, and when they give you that, now they’re on your email list, every time you send out an email, they get it. And as soon as they do that, and you can sign up for this so you can see how it works, as soon as they enter that data, they’re taken to the place to download that.

So, it could be an email, excuse me, it could be a podcast or a video that you made. I know Dr. Posey made one on incontinence. So it could be free video on the treatment of incontinence. In exchange for first name and email. And so you tell your, here’s what you say to your web person, if you want to do this, you should write this down. And this works for Constant Contact, A-webber, Ontraport (what I use most), Mail Chimp, all those different places.

All those different places, it all works the same. And you can go online and figure how to do this yourself, but it’s a 30-minute job at most for whoever does your websites for you. You say you want a form and you want it to be in the right upper-hand corner of your website. On the homepage at least, maybe on all your pages, but at least on your homepage. And it should offer the thing that you’re giving away. And it should only ask for their first name and their email address, that’s it. If you ask for last name, you’ll lose about half of them. So first name and email address.

And then you let them know that you’re putting out a new health lessons every two weeks. Don’t call your newsletter a newsletter. Nobody really cares about your news. Give them a name that implies some sort of benefit. So I call this Health Lessons. You can call yours whatever. And then tell your person to put that on the form.

If you supply them the link to the thing you want to give away … You realize also on Amazon, there’s a lot of books for free. You could literally find a book that you can read on Kindle for free and give that away. But I recommend you find something either audible of a podcast or a video. Preferably something that you did. And that’s it. That one thing is gonna increase the production of new patients by your website by 20 to 30 percent. Now we talk more about this sort of thing in my workshop where I teach marketing, but there’s your freebie right there that is just some of the best stuff.

Okay. Let’s see if there’s any other questions and then we’ll shut this down. We didn’t have a lot of questions on the websites. Okay. I think that’s it. You want to add anything? And thank you for helping us, Dr. Posey. I know you’ve had a lot of … I think more experience with treating lichen with PRP than anybody.

Do you still treat the clitoris even if the woman is there for urinary incontinence?

By the way, the way I think about this, it’s all the freaking O-Shot, it’s just we’re varying the way we do it. Just like you do a hysterectomy and you vary the method based on who you’re taking care of. It’s all the same thing. But Dr. Posey made a good point and this is worth remembering, because some people asked me if they’re there for incontinence, do you still treat the clitoris? Or if they’re there for sex, do you still treat the anterior vaginal wall? Or if they’re there for lichen, do you still do the rest of the O-Shot? Or for pain, do you still do the rest of the O-Shot?

There’s two reasons why you treat all of it. One is people lie about sex. Everybody does. And so if someone says they’re there for incontinence, maybe they’re not. Maybe they’re just too embarrassed to tell you. Or maybe they’re living alone, single and they don’t want to tell you they have a lover. Whatever reason. Maybe they just decided it’s not your business. And of course, you would want to treat the clitoris if you’re treating for sex, but you would also want to treat it for incontinence because if you look at the anatomy, the clitoral tissue actually comes around and forms some of the structure for urinary incontinence.

Also, it could be that those nerves of micturition that come down through that area are helped and our clitoris is acting like the wick to help rejuvenate those nerves of micturition. We do know that we have people with urgent incontinence that are getting better as well. And we’re not sure exactly why.

So I always treat the clitoris even if it’s for incontinence. And of course, if you read Grafenberg, the urethra is very erotic in women and you would definitely want to treat (even if there for sex). Also, you have the female prostate gland or the Skene’s glands, so you would definitely want to treat the anterior vaginal wall, not just the clitoris if you were treating for sex because the urethra is such a sexual organ as well.

And if you’re treating lichen and you’re hopeful that it’s going to get better, and you’re down there anyway, why wouldn’t you go ahead and treat the structures that have to do with sex so that that can be recovering at the same time you’re treating the lichen itself?

One big plug though, if they have sclerosis or phimosis, where you cannot pull that clitoral hood back, which many of them do, then you can go ahead and treat them, but make sure that you don’t stop there and you refer them to Dr. Posey or someone else in our group who knows how … If you don’t know how, someone else who knows how to free up that clitoral phimosis. So if you can’t retract the clitoral hood all the way back to see the shaft, if all you can see is the tip of the glans or if you can’t even see the glans, then they need a surgical consult from one of the people in our group so that that can be exposed and be more responsive. It’s hard to have good sex if you can’t get to the clitoris.

Okay. I think that’s enough rambling. Anybody else have any questions? If not, I’m gonna shut it down. Thank you for your help, Dr. Posey. Thank you guys for being here. I’ll put a recording up by the end of the day.

What can you measure with a ruler that gives a clue about a woman’s ability to have an orgasm?

Kathleen: I just wanna say something that I hear … I mean it’s going off on a little bit of a tangent. But to me, a lot of times, they want the O-Shot because they want that penis and vagina orgasm. And yes, it does help that somewhat, but I’m really … I look at a lot of vaginas, and I’m really paying attention to that distance between the clit and the vagina and/or urethra. And it really … You oughta start looking at it, Charles, because it varies with women. Some of them, it is like five to seven inches.

Charles: Yeah, it’s huge.

Kathleen: When I talk to those people, they have never had a penis and vagina orgasm. It might be something to really examine the person before. And if you really talk to them about why they really want the O-Shot, I’m seeing 70 percent of them really want that penis and vagina. And it’s being advertised or said it’s gonna make them have that. Just be careful because if that distance is a long way, yeah, the orgasm will get better. But to bring you to surgery, in my opinion.

Charles: Let me add to that. First of all, what you said is backed up by research. And that research I think is actually on our O-Shot website. But there was MRI studies showing that the further the clitoris is from the vagina, the harder … It was a correlation between … It was done about two years ago. You know this research, so you’re seeing it actually in your patients.

But there was a study where radiologists looked at women who can easily have orgasm and those who have trouble. And the distance from the clitoris to the vagina correlated with ability to have orgasm. And the size of the clitoris correlated.

Now, her conclusion was that she showed it, but there was nothing to do about it. Actually, we do know some things to do about it, putting someone on testosterone is going to make the clitoris larger. And it could be that doing our O-Shot® procedure actually helps, even though it’s not going to make that distance shorter or smaller, it could perhaps make it more responsive. But there’s also always a place for surgery, and there are ways to do that that you specialize in and others in our group to bring things closer together.

Now, and I’ll also say that of the things that we treat, trying to help a woman achieve penis and vagina orgasm, who is able to have it with a vibrator, is one of our more difficult problems. I think our success is probably in the 30 to 40 percent range in that group. Where if you’re treating incontinence in a younger woman, stress incontinence is probably closer to 80 to 90 percent.

So I agree that something ... And it brings up another point in that I recommend, especially in the beginning, that people stick to the problems that we have the high success rate, so the provider doesn't become discouraged. I know you were very motivated and trusting it. But way back, years ago, when we didn't have so many people doing this and we had less research to back it up. But anybody, even with our current researcher who is just starting out, they should probably avoid treating, I think, until they have some success under their belt, the people who never had an orgasm because those are the people who are more difficult and probably they're always gonna need testosterone on top of what we're doing, I think.

And the people who we just mentioned trying to have an orgasm with penis and vagina sex, they're more difficult. Stick to the stress incontinence, the dyspareunia, the lichen sclerosis, the women who can have an orgasm and wants to be stronger, those are our more easier cases. And in all cases, always, always, always, in my opinion, if they don't get well by the end of 12 weeks, then either offer them another treatment or give them their money back because we can make a profit and take good care of people without having to have people feel like we ripped them off.

Anything else, Kathleen?

Kathleen: I didn’t mean to say it wouldn’t help because I do think it helps and I do think you can even … I think the O-Shot, by putting it in the vagina, does shorten the distance a little bit. And maybe millimeters like what the P-Shot is doing. And it can get better, it just can’t … When you really see a big long distance, I would ask them and then I would just say, “Your orgasm is probably gonna get stronger, easier to obtain, but it may not help that.” I don’t know, it’s hard to give them a negative … I wouldn’t give them a negative embedded command. Just watch it if they’re there for penis and vagina orgasm.

Charles: I’ll tell you what I tell everybody. It’s good advice. And what I tell everyone when I’m leaving the room is I’ll say, “You just spent whatever amount of money it is. And for that much money, you have to love it. And if you don’t love it, I want to know about it.” Because of course, I’m gonna be following up with them. But what I found when I follow up with some of the people … So when people contact me and they tell me they’re not happy, I refer them to the doctor who took care of them because I’m not their doctor. So I don’t need to be involved. But it’s helpful for me to know who took care of them. Then I call the doctor and talk to them and see if I can offer help.

But back to this thing about satisfaction and setting expectations. I think that what I’ve seen happen sometimes when people are not happy is they never let their doctor know. Because maybe they’re afraid they’re gonna hurt their feelings or there’s gonna be some sort of conflict or something. I think it’s helpful to actually tell your patient, “I want to know. I want to know if you don’t love it because I want to take care of you, and I don’t want you to feel like that our energy and time and your money has been wasted.” And that really helps a lot, both with you getting them well and helps prevent them sliding away disgruntled without you ever knowing about it.

And in the process, you can say what you just mentioned, Kathleen, that if it’s a more difficult case, it’s worth telling them, “This is something that a percentage of,” if you’re dealing with someone who’s trying to have an orgasm with penis and vagina sex, “This is something that doesn’t work as well. We have a much higher percentage with treating stress incontinence, but we do have successes that by our surveys, are in the 30 to 40 percent range. If you want to try it, we’ll do it. But I want you to love it. And if you don’t, let me know. And we’ll either repeat it or we’ll figure out something else, including, I won’t keep your money.”

And in the end, although you give back money occasionally, you wind up making many more people happy and making more money and you sleep better at night.

Okay, I think that’s it. Thank you guys for your attention ’cause this thing … What we’re doing here, I think, is really changing medicine and I’m the facilitator between all you guys thinking about it and all the feedback and all the good research. So keep it coming and I’ll try to keep pouring our money back into it.

We have two double-blind placebo studies going on now. We’re having a little trouble filling the orgasm study (click to help), so I’m gonna put out a link to that again. So if you guys know people who live in the Washington D.C. area … Bottom line though is we’re investing into the research. We’re investing into supporting our group. And I think you’re gonna see medicine change a lot in the next five years from what we’re doing. Okay, you guys have a good day. Thank you, Dr. Posey.

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Board Certification in Botox & Aesthetic Medicine

Is there a Board Certification in Aesthetic Medicine?

The official board for regulating medical specialties is the American Board of Medical Specialties.

You can see their list of recognized board exams here (click)<–

There has been great discussion regarding the Board Certification of Aesthetic Medicine. Currently the American Board of Medical Specialties (ABMS) does not offer a board certification in Aesthetic Medicine.

Also, the ABMS currently states that “antiaging is not a medical specialty,” and therefore no association or organization can officially be offering “board certification” in aesthetic medicine at this time.

Oddly, Botox, Juvederm, and cosmetic injections of PRP are not part of any of the board exams at the present time, including the American Board of Plastic Surgery.

Any private company, private company owned association or aesthetic association that offers “Board Certification” does so without the endorsement of the ABMS.  “Physicians like to be board certified like they are in their own medical specialty  however since the ABMS doesn’t offer Board Certification, many companies have decided to create their own. It’s not illegal for someone to make up their own board, but this is not the same board certification as in Family Medicine, Dermatology, Emergency Medicine or any other recognized board certification, this is just a made up one,” says IAPAM Executive-Director Jeff Russell.  “We often hear from physicians who have spend thousands of dollars on obtaining these aesthetic medicine board certifications only to find out they aren’t recognized by anyone, its very disappointing to them to say the least,” continues Russell.

Of course, it was all made up in the beginning, so you can make something valuable by the training involved and the people who undergo that training. So, you could make up a board exam and then make it very valuable (even if not part of the ABMS system) by making the training valuable and by training top notch providers. Some may argue that the A4M board exams meet this criterion. But, the terminology of “board exam” could be misleading if abused and granted to an inferior training program.

The ABMS is a non-profit organization empowered to regulate the certification of medical specialties.  Before the formation of the ABMS, a physician could advertise that he/she was a specialist in any medical arena.  However, since its establishment, the ABMS “certification” is the gold standard for medical training and examinations, thereby ensuring a pre-eminent level of education, ethics and care across multiple medical specialties.

The ABMS clearly states that its mission is “to communicate to external stakeholders that ‘board certification’ is the major marker of quality for physicians’ performance and that the ABMS is recognized as the organization that establishes these standards and criteria.”  That said, the ABMS also states that “anti-aging is not yet considered a medical speciality”, akin to plastic surgery or dermatology.

Also, at this time, the ABMS does not offer a “board certification” in aesthetic medicine.

The Cellular Medicine Association offers certificates of training (click)<–. This is NOT the same as a “board certification.” Anyone else may call their training a “board exam” if they want, but the official recognized boards are listed here (click)<–

Hope you find this useful.