After trying to resolve quietly, the Cellular Medicine Association was forced send the following letter:
Cellular Medicine Association
With the FDA finally taking some much needed action that was delayed because of COVID, there’s some confusion about what the best in-office policy might be regarding PRP. Talk all of this over with your attorney, but here’s some documents that have been helpful to me….
First of all, the FDA does NOT regulate any procedures–NONE. The FDA does not approve of cholecystectomy or hysterectomy or any other procedure because it’s not what the FDA does. So, when the someone says that the FDA has not approved of the O-Shot® or P-Shot®, they are technically correct; but it’s the same as saying the FDA has not approved Toyota Celica or of the roof or your house, it’s just not what they do! If someone criticizes your practice of doing Vampire Facelifts® by saying that it’s not FDA approved, just realize it’s an uninformed, alarmist statement.
Here’s more about the FDA not overseeing procedures<–
Second, PRP is not regulated by the FDA (neither is urine, skin, or saliva).
PRP is exempt from FDA regulation and regulated solely under section 361 of the PHS Act. From the FDA’s guidance: Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; then
Click on this link, then go to Page 22; then read Section V,A; you will read the following:
“This guidance also does not apply to products that fall outside the definition of HCT/P in 21 CFR 1271.3(d). For example, platelet rich plasma (PRP, blood taken from an individual and given back to the same individual as platelet rich plasma) is not an HCT/P under 21 CFR Part 1271 because it is a blood product. Accordingly, FDA does not apply the criteria in 21 CFR 1271.10(a) to PRP, and PRP is outside the scope of this guidance.”
The FDA SHOULD & DOES regulate the devices we use to prepare PRP and you should be using one of those devices when you do our procedures.
Using lab equipment made to measure blood to make PRP to inject back into the body is not good medicine.
We are physically adding PRP into a space to create new healthy tissue which is on label for bone and off label for other areas; this “off-label” use of the device (but not for the PRP) is supported by research in many areas of the body
These are PROCEDURES (not simply injecting a drug)...you’re doing hydro-dissection of tissue when you do these procedures and it’s important that the procedures be done in the correct way.
Just shooting PRP anywhere does not work. You could give morphine sub q anywhere you wish and get the same result; not so with PRP.
The FDA recently stated that on June 1, 2021 it will begin its enforcement efforts on clinics and devices companies that promote, use or sell products that go beyond their established minimal manipulation standard for Human Cells, Tissues and Cellular-based Products (HCT/P). Some regenerative medicine products in the market are being mislabeled as a homologous use tissue (361) while the FDA has clearly classified them as unapproved biologic drugs (351).
The FDA DOES classify stem cells, exosomes, amniotic fluid, and mesynchemal cells as drugs, so just don’t use them without an IND or IRB.
I hope that helps clear up the misinformation.
Charles Runels, MD
Cellular Medicine Association
Schedule a Marketing Consult & Orientation “Sure Start”
Platelet Rich Plasma for the Treatment of Scars<–
Research about Platelet Rich Plasma
Platelet Rich Plasma Hair Protocol 1
Platelet Rich Plasma Hair Protocol 2
Platelet Rich Plasma Hair Protocol 3
Cellular Medicine Association
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.
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.
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.
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.
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.
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.
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.
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.
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?”
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.
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.
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?
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
Here’s a summary of the FDA regulations concerning PRP…
Here’s a nice summary article with wonderful references…
Here’s an abstract summary of the above article…
Here’s where the FDA plainly says that PRP is not under consideration for regulation..
New England Journal Article about Stem Cells…