Here’s the secret legal story behind the world’s most famous celebrity selfie

The Secret Legal Story Behind Kim Kardashian’s Famous “Vampire” Selfie
&
Altar™..the Latest Vampire Skin Therapy™

Recently, People reported on Kim Kardashian’s most famous selfie—her face covered in blood after a Vampire Facial®. Here’s the legal story behind the photo; how Dr. Charles Runels, MD created the legal mechanism of the Vampire Facial® procedure to protect women from life threatening diseases.

Because the procedure involves a device that punctures the skin (microneedling), the procedure can spread disease if done improperly. Some of the cheaper devices used to do the microneedling will suck blood up into the handle; therefore the next patient could potentially be inoculated with the blood-borne pathogens from all of the people previously treated with that same device—medically similar to having sex with everyone previously treated.

Also, the device used to prepare the patient’s own blood for topical treatment after the microneedling component of the Vampire Facial® is done, should be approved by the FDA for preparation of blood to go back into the body. Kits made to analyze blood for testing should not be used.

The FDA does not approve a person’s own blood, nor does the FDA approve procedures. But, the FDA does and should approve both the device used to create the microneedling-puncture wounds as well as the device used to prepare the platelet-rich plasma (PRP) used drip onto the skin after the microneedling.

Providers of the Vampire Facial® should also understand which conditions can be treated and which should not be treat with the procedure. Other techniques, such as how to provide proper anesthesia should also be understood by providers.

Dr. Runels (called the “Orgasm Doctor” by Cosmopolitan & by the Guardian) thinks of himself as a “Calvin Klein of medicine,” & initially designed the Vampire Facelift® procedure. Out of that process, he designed the Orgasm Shot®, the Vampire Facial®, Vampire Wing Lift™, Vampire Beast Lift®, and the Priapus Shot® procedures—all created Dr. Runels combining science with the principles of art.

To help keep patients safe, Dr. Runels secured trademarks with the US Patent & Trademark Office so that he could protect patients by limiting advertising of these procedures to providers who agree to follow specific methods and to use FDA approved devices. These marks serve to identify providers who understand the design in the same way a Calvin Klein tag goes on a garment manufactured by another person but who follows Mr. Klein’s design.

The Cellular Medicine Association (CMA), founded by Dr. Runels, certifies providers to do the above procedures and coordinates and supports the research and clinical practice of physicians using cellular medicine for the improvement of health, beauty, and sexual relations. Anyone can claim to be doing microneedling, but only those certified by the CMA can claim to be doing the Vampire Facial®. The provider groups include over 2,000 doctors in 54 countries who contribute immensely to the ongoing research, development, & teaching.

Altar™, the latest Vampire Skin Therapy™

This month, Dr. Runels announced the release of Altar™—a new Vampire Skin Therapy™ — that enhances & protects the beneficial effects of the Vampire Facial® procedure. Altar™ can only be purchased from certified Vampire Facial® providers.

 

Who is Charles Runels?

Transcript of the Video Can be Found Below…

The normal time for physicians to accept a new procedure is 20 years (10 to do the research and another 10 for physicians to routinely offer)…

Case examples..
2. Antibiotics for Gastric Ulcers. Barry Marshall won a Nobel prize for the discovery. He gave up gaining acceptance in Australia, then came to the US and only after the popular press started talking about it did physicians start reading his research. He GAVE HIMSELF an ulcer by drinking the
bacteria.
Ulcers were BIG business (they cut them out and made many $ with surgery and Tagamet®. People assumed the cause was already known and quit looking for another cause…so they were not interested in Dr. Marshall’s research.
Guess what? Now, midurethral slings are BIG business so “who needs another way?”
I don’t claim to be on the level of Drs Marshall and Forssmann but both of these 2 men inspired me. I actually pulled up Dr. Forssmann’s story on Wikipedia and read it for a few minutes to get psyched out before I injected my own penis with PRP (which I did twice before I injected any other person’s penis or clitoris/vagina).
Now, as you see the response of physicians to my procedures, you can see so many physicians who don’t see that they don’t know what they don’t know. It’s OK, it’s the natural course of things. Hopefully it won’t take the usual 20 years before we finish the needed research & women are routinely offered the option of an O-Shot® & men a Priapus Shot® procedure.

Transcript of Above Video<–

Charles Runels: Hello, I’m Charles Runels, and I’ve recently been asked quite a few times, “Where did these ideas for the O-Shot and the Vampire Facelift,” I did design those procedures, “Where did they come from, and who are you?” I thought it might be helpful to know why initially I actually hid myself. I tried to stay secretive about where the idea originated, where they came from, and why I tried to stay hidden for at least two years.

A little bit about how I transitioned from being an internist slash emergency room doctor to becoming the guy who’s lecturing around the world about women’s sexuality. It wasn’t an intentional thing that I set out to do. What happened was, after 12 years in the emergency room I started taking care of women and doing hormone replacement before it was cool. 18 years ago in the year 2000 I was doing research with growth hormone, before Suzanne Somers wrote those books. Because of that, and because I was ahead of the curve somewhat as far as people knowing about these ideas about caring for women the way it’s commonly done now, back then the way to take care of a menopausal woman was to give her Premarin, and no one was really prescribing testosterone. If they did it was an old Premarin missed with testosterone. It was just a completely different level. Nobody was measuring hormone levels to speak of in normal post-menopausal women. It just wasn’t so good.

I became involved in the research out how to make that better, as an internist, but I had a background in research. I did three years as a chemist before I did medical school. But mostly I just had an intense desire to make women well. What broke my heart over and over and over again, with literally thousands of women, is they would come to my office and sob, and they would tell me, “I love my husband,” and I heard this story literally thousands of times. “I love my husband, so I don’t want to tell him that sex is not so good. Or that I don’t really desire him. And I don’t know why I don’t desire him, because I love him, and sex used to be wonderful, but I’m afraid I’ll hurt his feelings.” They’re sobbing, and they don’t know what to do.

Then I would do the things I knew what to do 18 years ago, doing these things with testosterone and thyroid, things that are commonly done now. Then often times the man would then not be able to keep up with the women, because her sexuality is better and her libido goes up, she loss weight, and she feels wonderful and sexy, and now her libido is outrunning his. So I started focusing on, how can I help this man catch up with the woman. 18 years ago, 2000, mostly it was just body builders that were using hormone replacement. You go back a little bit before that, we were still telling men that the most common reason for impotence was psychological. It’s hard to believe that, but in the 1980s when I was in medical school we thought, or it was taught, that 85% of men who had erectile dysfunction, it was psychological. That was actually taught to urologists, that they should become counselors. Then of course once we had all these medicines that help men, we knew it wasn’t al psychological. It’s the reverse, 85% of it was neurovascular.

I’m doing all this, and I’m taking care of women, and again, so how’d he go from there to coming up with a vagina injection, like the O-Shot? That’s the question people, “Who is this guy?” What happened was, in a lot of women, when they would try to lose weight, they would want to gain their weight back when they saw the fat go out of their cheeks, and when the adipocytes left and the wrinkles would appear, and they would feel older even though they were leaner. To counteract that I learned to do fillers, like Juvederm, in the face to bring their face back so they wanted to keep losing weight. I became, I think, good at it. I won’t say very good but some people say very good at it. I know this, I trained with the best in the world. So 10 years ago I started doing that.

Now I’m plugged into the aesthetic market, but I’m still doing it mostly to encourage people to lose weight, and then I discover how important it is to women, and how it’s changing their whole life when they feel better about their facial appearance. It makes them want to work harder on their health than their fitness. Now I’ve got these three little satellite things going on. I was a ex-research chemist who was interested in technology, helped design some things that are still used by our soldiers in defense work, and then I was involved with wound care, and healing and tissue growth, that’s part of the wound care in the hospital when I was a ER guy. Now I’m tuned into sexuality, not because I set out to do that, but because I was trying to take care of women who were just telling me what was wrong with them, and happened to be involved in some research about how to do that. So I’m taking care of the women’s sexuality with hormones, I understand wound care, and I’m doing cosmetic medicine.

Here’s what bothered me. This was to me, this still goes on and it really bothers me. What if, when you go down the street, all the signs for the restaurants just said “beef,” but you couldn’t tell if you were at a hamburger joint or a gourmet restaurant? Sometimes you might want one or the other, but at least you should know which one you’re getting when you walk through the door. Instead one says McDonald’s, I love McDonald’s, maybe I want McDonald’s one day but maybe I want a gourmet filet the next. That’s exactly what was going on with cosmetic medicine, and still goes on. Because you see not the procedure advertised, but the material. You see Juvederm advertised. Well Juvederm, you can take a syringe of Juvederm and make a woman look natural, and younger, and she can see her mother or her husband the next day, and they think, “Did you get some rest, you look great today,” and not even know something was done. Or you can take that same syringe of Juvederm and make her look like she’s got sausage for lips, or like she’s got Donald Duck for lips. If you see a doctor advertising Juvederm you don’t know which you’re going to get, because you’re just like seeing beef without knowing if you’re going to get a gourmet preparation or a fast-food hamburger.

I wanted to change that, but I didn’t really know how to change it, and I still don’t really know how to change it in the Juvederm world, but someone brought to me, and this is where the procedures happen, this is where all the starts collided. Back in 2010 someone brought to me a centrifuge that had been used by the orthopedic surgeons to prepare platelet-rich plasma for the knees, and by the dentists in wound healing. The person bringing the centrifuge says, “This has been FDA approved for preparing platelet rich plasma, and if you use it …” Of course it’s blood, the blood’s not FDA approved. The FDA doesn’t approve your hair, your urine, your saliva, or your blood, but they have to approve the device that makes the plasma to go back into your body. He says, “This has been FDA approved to prepare plasma to go back into the body, and it’s been shown to cause new tissue growth, new blood flow, new volume, and there’s never been a granuloma or a serious infection or a serious side effect from a platelet rich plasma. You should try it in the face.”

I thought, this is wonderful, because if this works in the face … Instantly, because I was tuned into the sexual problems, I thought if this works in the face and does all those things, then this should help the genitalia. Honestly initially I was thinking the male genitalia, but I was following the work that had been done by gynecologists when it comes to injecting around the urethra for sexual function and for urinary incontinence. So I’d been following that very carefully because I was involved with caring for women, but I thought, let me use it in the face first and see how it works, read the literature, learn how the thing works, and then I will use it in the genitalia. I started reading the literature, everything I could find about platelet-rich plasma. At that time there were 5,000 or so papers out, now there’s over 9,000 research papers, and I read thousands of them. I can’t tell you I read all of them, but I read a lot of them.

Then what I started seeing is, it really worked in the face, but I needed a name to call it, and I wanted it not to be a generic PRP, because I didn’t want to be advertising beef and you don’t know what you’re getting, or advertising Juvederm and you don’t know how it’s going to be used. I said let me give it a trial of having a name that means using this platelet rich plasma in a very expert way, and combining it with the Juvederm to create this gorgeous shape. If I can make that work in the aesthetic space, maybe I can make it work in the sexual medicine space and protect patients from having something done that would be, obviously metaphorically, the equivalent of a duck lip done in the genitalia. Could be devastating psychologically and physiologically, and I didn’t want stupid things being done to people’s genitalia, so I needed a way to protect it. You can’t protect the name platelet rich plasma, that’s the name of a body fluid, but I thought if I could organize a group of doctors around the procedure, then I could protect it if I owned the name of that procedure. Let me give it a try in the face first.

The press had used the word “vampire” already in association with PRP, but they were calling it vampire therapy, and I didn’t think … I particularly don’t want to have therapy, or they were calling it vampire filler, and I didn’t want to be filled up, but what I could see it was actually doing was causing a facelift. Lifting the tissue away from the skeleton, a way from the skull, and truly lifting it away back into a younger shape. That’s what I did with the material, and I said let’s call it the vampire facelift. I trademarked it, and I started recruiting physicians who would agree to follow the specific method that I developed, and to see if I could protect that method, and it just went crazy. It went berserk. The people loved the name, it was all over the press.

I spent the next two years … I tried to hide myself, because I didn’t want it to be about Charles, I wanted it to be like, who knows. You have to do research to figure out who owns McDonald’s, you just see the golden arches. I do not have a franchise, but the idea was, there’s a way that that is done, as in the way that hamburgers are made, and there’s a way to do this face, and I wanted only people who understood that way to be able to use my name. I didn’t want it to be about Charles, I wanted it to be about the patient and whoever was doing the thing.

To this day people get it confused. The New York Times interviewed me, and I love the New York Times, but they interviewed me and the reporter said, “Dr. Runels liked the name Vampire Facelift so much he trademarked it.” I did like it, because I thought of it, and when I Googled it in 2010 and first used it in early 2010 … Matter of fact, the first YouTube video I put out was on April 20, 2010, and when I put that out you could Google “Vampire Facelift” in quotation marks and you would get zero hits. I don’t know many things you can Google and nothing comes up, but that phrase, there was nobody else on the planet using it. I thought great, this is a name that I can circle around, and if we can stamp it out and protect it, this is what’s important to vaginas and penises, I said if I can stamp it out and protect the way this method is done, then I can make sure that nothing stupid gets done on a routine basis to women’s vaginas. I guess technically it is true that I liked it and so I used it, but I liked it because I thought of it.

As I worked with the faces, about four months into that I thought, let’s do this thing with penises, and then it evolved. Because basically a clitoris is embryologically like a small penis, so the first penis I injected was my own. At this point I’m still trying to hide the identity of me and promote the physicians that are agreeing to help me on this mission, the mission being, let’s do something about these women who are suffering. At that point we had not one drug approved for women. Not one FDA approved drug.

We have over 20 FDA approve drugs and devices for men, we have one FDA approved drug for women, and it’s a psych drug. I’m not saying it’s crap or that it should not be used, but I’m saying … That’s what we used to tell men, that it was all psychological, and the only drug we have now, it’s like saying we have one drug to help you and it’s a psych drug, so basically it’s all in your head. But if you can have problems with circulation in the penis, and a clitoris is like a tiny penis, it’s usually five inches long, you’re just seeing the tip of it when you look at it in the body, then you can have the same neurological, the same neurovascular problems, both nerves and blood flow, could go on with the clitoris. The same autoimmune process that causes lichen sclerosis of the foreskin of a man can cause it in a woman. Autoimmune processes are involved with Peyronie’s disease. All those things are analogous.

Anyway, back to the story, I started circling around and teaching and protecting the group for the face, and then forming the group for the penis, and then forming the group for women. When I started teaching people and they were saying, “Charles, this thing works,” I thought wow, it really does work, it’s not just me making this up. So we started doing research, and the research was positive. So far every study we’ve done, and we’re up to six studies, two in the works, every one of them has been positive, both with men with Peyronie’s disease, men with growth, rat studies showing new nerve growth when you inject the penis. Of course men don’t volunteer to have it chopped off, but if you inject the penis of a mouse and then you chop it off, the nerve grows back as it would if someone had prostate surgery and had nerve damage. We are seeing that happen.

Eventually though, this is what happened. Charles who was hiding eventually had to come out, because anything that’s valuable enough to get mentioned just last week in Allure magazine, Fox News, Cosmo, the Daily Sun, and the Daily Mail and the Sun, all of those in the past week, obviously that’s a lot of advertising, a lot of attention, and now some people want to pretend like they’re a part of our group when they’re not. Because of that, and only because of that, I’ve had to come out of the shadows and say, “Yeah, this is a thing, and don’t try to use it if you’re not part of our group, and if you do, this is the guy that’s going to have attorneys shut you down.”

Because I don’t like it when I have women, and this happens at least every other week, when I get an email from a woman who says, “I had this horrible procedure where it hurt like crazy and I bled and it didn’t do anything for me,” and I say, “Who did your procedure,” and they send me the name of someone who’s not in our group, doesn’t even know what they’re doing, never been trained by one of our teachers. We’ve got 50 or so teachers, a little more than 50 teachers, in 40-something countries and still growing, and so it’s still not about Charles. It’s about taking care of patients, it’s about doing the research, and we’ve spent hundreds of thousands of dollars on research, hundreds of thousands of dollars on attorneys taking up for people who had things done to them by people not in our group. We’ve spent hundreds on educational materials we give for free to our patients. We all do work for free for patients. Yeah, it’s not covered by insurance and some of them pay us money, but a lot of us do work for free as well.

The bottom line is, it’s still not about Charles, but Charles wanted to be a doctor when he was in the first grade. He wanted to do one little thing that might help medicine, and what’s happening is, Charles, through the doctors who have trusted this process, and the doctors who are also passionate about taking care of women and men … Because they know sex is not just about pleasure, it’s about putting relationships back together and keeping relationships together, when a family breaks there’s a ripple effect that causes anguish throughout the whole neighborhood. It’s not just the family, it’s the people at their work, at their church, at the school. The kids have to travel back and forth. There’s a social fiber that’s built around the family. Ray Bradbury said that the family, it’s the happiness machine. That’s what it is. Your family might be your dog, that’s wonderful. Your family might be your wife and your 10 kids. But whatever, your family is your happiness machine, and bad sex breaks that happiness machine down.

Here’s the thing. I’m a internist from Alabama. I’m not a plastic surgeon, gynecologist, urologist, I’m nothing fancy. But I think we have a mission that is world-changing, and I will be ferocious to anyone who tries to hurt that mission, and hurt anyone in our group, or hurt anybody who’s attracted to our providers because of our mission, and because of our message and our reputation and our research. If someone tries to be involved who isn’t legitimate, I will punish them as severely as I can no matter how much it costs. If someone wants to join our group, I will take our funds, and we spend hundreds of thousands of dollars every year, I will take our funds and I will help finance the research, I will have people be treated for free. Right now we have research going where people can be treated for free. I will protect, I will support, I will educate, I have literally flown around the world, I will do whatever it takes.

It really doesn’t need to be about Charles, but because people have asked, I’m telling you who I am, where I am. We have this great organization called the Cellular Medicine Association, and what really makes our mission work, which is change the fabric of the world by helping sexual health on a very basic cellular way. Then because of that sexual health the family’s made stronger. When we can do that, we have a reason for being here. We have a reason for using our brain. That’s what our doctors do, that’s what our researchers do, and that’s what I hope that you will help us do. I’m very grateful for your attention.

Charles Runels, MD

1-888-920-5311
Cellular Medicine Association

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Vampire Hand Lift® with Amnion

Members of the Vampire Facelift® provider group, can login to the member’s site to see more specifics of how to use Vampire Amnion™ to rejuvenate the hands and face and to receive special pricing from the largest supplier of quality amnion in the U.S.

Over 1,000 research papers about amnion (click)<–

ONLY live birth amnion is used (no aborted fetal tissue).
Here’s the company that harvest the amnion for us (click)<–

More details about how to do the procedures in the member’s sites…
O-Shot® providers
P-Shot® providers
Vampire Facelift® providers
Cellular Medicine Association, Inc.

How the Vampire Facelift® Procedure Works

Find Nearest Vampire Facelift® Provider<–
Apply for Training (for Physicians and Physician Extenders Only)<–

Only Members of the Vampire Facelift® provider group are licensed by the Cellular Medicine Association to do the procedure. Any other providers advertising the procedure are doing so illegally and may be offering an inferior procedure.

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PRP & FDA

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<–

New England Journal Article about Stem Cells…
click <–

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

Transcript

Charles Runels: To clear up some of the confusion concerning stem cells and their regulation by the FDA, I thought I would go through some things that have been published both by the FDA and others.

First of all, this is a really informative editorial-type article in the New England Journal of Medicine talking about the FDA regulation of stem-cell-based therapies. What it says is that, “Any stem-cell-based product that contains cells or tissues that are highly processed,” this is a quotation, “are used for other than their normal function, are combined with non-tissue components, or are used for metabolic purposes would be subject to the Public Health Safety Act, Section 351.” This appeared in October of 2006. Other articles have appeared since then with more and more strict-type warnings that, outside the regulation of IRB, stem cells will be relabeled as a drug-type product rather than just tissue, so let’s look at more about what that means.

This is a really nice article that talks about the definitions, current use, and the FDA stance on platelet-rich plasma, and so let’s go through this. There’s a link to this here below the video. There’s a link to this article. First of all, it’s nice to look at what exactly is regulated. Is it the platelet-rich plasma or the device? Here this author say the first point of confusion is that in there are many pathways in which a drug or a medical device can be brought to market. Most of the FDA-approved kits came through a 510(k) where a device is given clearance because it’s equivalent to a previous device, and these devices were approved to prepare platelet-rich plasma for use in bone, for mixing with bone transplants, and they’ve been shown to help, so if you’re a bone graft. There are numerous PRP preparation systems on the market with FDA clearance. Nearly all of them are cleared for producing platelet-rich plasma mixed with bone graft materials to enhance the take of that.

A PRP system with clearance indicates a device is safe in that it does not create a preparation that’s hazardous or dangerous, which could happen if you used a lab kit that’s made to isolate platelets, because the level of sterilization is different, and a different method is used that is pyrogenic, and a different level of sterility is used, so these FDA-approved devices are made to prepare the plasma in a way that it is safe. Number two, that its performance is substantially equivalent to a predicate PRP device, meaning that it’s demonstrated the capability to actually isolate the platelets from the whole blood, but the clearance applies to producing PRP for use with bone graft materials. Now, if you want approval for a specific indication other than that, then it requires a BLA or a PMA application, which is more rigorous and much more expensive but, by definition, platelet-rich plasma is a biologic.

Now, what does the FDA do? The FDA is responsible for protecting the public health by regulating human and animal drugs, biologics, that’s vaccines, cellular and gene therapies, medical devices, food and animal feed, cosmetics, and products that emit radiation. Where does PRP fall into this category? Under that idea, then PRP would be considered a biologic. How is a biologic regulated? For clinicians using PRP, it’s important to understand how they regulate this.

The first is whether it’s being used as intended. If the devices are intended for use with bone grafting, then off-label, which sounds scary to lay people, would mean that it’s used in a different area, but it just means that you’re still using materials that have proven to be safe just with a different indication. For office injections to be on-label and approved, then you would have to submit animal studies and clinical trials, which is very time consuming and very, very costly. The problem is, because it’s not a drug, who pays for the very costly process? Which is where our group is coming into play to at least give the ideas that, just the idea … To do a pilot study will cost six figures, so to do one of these type studies would be in the millions, and there’s no pharmaceutical company or other, even, device company that’s yet stepped to the plate to do that. The reason the device companies have not is because they know, if they fund this research, there’s 30 other kits out there that you could use other than the kit that funded the research.

This is key. The FDA does not regulate the practice of medicine. Clinicians are free to use a product off-label, and we do this all the time because we know that, if there is research to support the idea, then waiting for the pharmaceutical company to pay the money or something like blood where no one’s going to pay the money, most likely, then we do the research, and the FDA lets the doctor decide. Over half the drugs that are prescribed by oncologists are off-label. In some studies, 20 to 30% of the prescriptions written by a family practitioner are off-label, meaning that we take the evidence … We don’t just think of these ideas out of the blue. We take really good research and evidence-based ideas and see how they apply, so exactly how that’s done. These guys give a really nice idea of how that goes.

Clinicians have the responsibility to be well-informed about the product to base its use on scientific rationale and sound medical evidence and to maintain records of the use and the effect, so keep good medical records and base it on research. They do not require the submission of IND, or IDE, or oversight from Institution Review Board. If you’re going back, the scenario they’re using here is using it in a joint, injecting it in a joint, a young patient with glenohumeral arthritis, a review of the literature is performed, and it shows that it’s a reasonable idea, and so the PRP is used, and they keep a record of what happens like any good medical practice.

Conversely, if you intended to use investigational manner, as in do a formal study versus treating a patient, then you need an IRB, which is what we did with our lichen sclerosus study, and it’s what we will do with our blinded study that’s coming up and other studies that we are funding with our provider group. That’s what the money goes to. A huge portion of that goes to funding our research, and the other bulk of it goes to legal so that others who are not basing their ideas on our group’s collective efforts of thousands of procedures with comparing notes and comparing outcomes, then that would be misleading to let patients think that their doctor was plugged into that conversation when they may not even be using an FDA-approved kit. If you do a formal study, then you need an IRB. If you’re treating an individual patient based on clinical rationale and using an FDA-approved kit, then that does not require an IRB, or you’d have 30% of the prescriptions being written, between 20 and 30%, or more if you’re an oncologist, not … us not being able to help people.

If you look at the Code of Regulations, there’s this tiered approach, and it gets more specific. The FDA had a ruling, 2005, that any procedure in which human cells are manipulated is subject to clinical oversight. More than minimally manipulated was the exact phrase. If they’re more than minimally manipulated, then it must be treated like a drug. Then that sparked this debate about does the FDA really have the power to regulate the practice of medicine with the respect to biologics? Back to our PRP example, PRP obtained from a 510(k)-cleared device is unregulated because it’s just blood. It’s, basically, you’ve isolated the platelets but you’ve done very little to them, but people became concerned is that more than minimally manipulated? To date, the FDA has not attempted to regulate PRP or even activated PRP where you add a few drops of calcium chloride.

Here’s the approach of the authors of this article who are using PRP off-label. They discuss it with the patient. They review the research. They have a consent form that people sign where they promise them no guarantee, that their options include not treating the condition at all, that they encourage the person to talk to their primary care physician, which I always do. I’ll even make phone calls to the primary care physician so other physicians are involved in the conversation. Then, in the days following the injection, you follow up with phone calls and records. This is what we will be doing with some of the surveys that’ll be sent out so we can collectively pool our data. They say, “To date, we’ve not observed any serious adverse events or unanticipated effects that fall outside the scope of what you would expect from an injection.”

In summary, there are several systems for obtaining PRP that have received 510(k) clearance, which indicates that a given preparation system is substantially equivalent to a predicate device and that it’s safe and capable of producing PRP. Any doctor not using an FDA-approved device, in my opinion, is practicing substandard medicine, unless, unless, I will qualify that, the doctor’s gone through the very expensive $100,000 process of creating a lab that’s up to standards, then that would be an exception, and that requires a whole different conversation and approval by the powers that be.

Second point, per the FDA, PRP’s intended uses in an operative setting to mix with bone graft materials to enhance bone graft handling properties. Outside setting is considered to be off-label use, which means that you’re using research. Clinicians using PRP off-label as injections is part of good medical practice in the best interest of the patient have the responsibility to be informed on the product and to keep records of it use. However, they do not require oversight from the FDA. The language in 21 CFR 1271 regarding the manipulation of cells has impacted the use of cultured stem cells, causing concern for some over-activated PRP.

To date, the FDA has not attempted to regulate activated PRP, so even adding a few drops of calcium. Calcium’s in the blood already, so it makes sense that adding extra calcium … so you’re taking blood from a patient, taking part of that and putting it back into the same person, and you’re putting calcium, which would be in that person anyway, in there with it, or thrombin, which the body would make anyway. You would be making that thrombin, again, from the person’s own blood, so either calcium, which is in the blood already, or thrombin, which the person would make already, is used. Clinicians using activated PRP should be mindful of these concerns and stay informed, so let’s stay informed.

The FDA has a meeting scheduled September 12, 2016 where they will have an open discussion about the use of stem cells, regulation of human cells, tissue, or cellular-tissue-based products, but notice this. The FDA welcomes comments that will enhance the usefulness and clarity of these documents. They’re getting ready to shut people down is what this amounts to. By the way, I am not anti-FDA. The FDA may not be a perfect institution. Any time you have people in a large institution, there’s always the possibility of imperfect people doing imperfect things, but the FDA serves a very important function, and having a device that I’m sure is giving me a sterile liquid that actually has platelets in it is extremely important, and it’s reproducible so that I know it’s going to be about the same concentration no matter which one of the doctors in our group uses it. Without that, we can’t have a meaningful conversation, and we have less degree of safety.

Notice this next sentence. The FDA recommends that comments exclude discussion of products that do not meet the definition of a HCT/P, go back up here, human cells, tissues, and tissue-based products such as platelet-rich plasma and other products. The FDA is telling you right there that the platelet-rich plasma does not meet the definition of HCT/P. The FDA will consider information obtained through the public hearing in the finalization of the four draft guidance documents, so they’re creating their new regulations, and people are signing up. If you are using stem cells, I would recommend that you keep up with this. As PRP providers, we will keep up with this but, as of now, there it is in black and white. The FDA does not consider platelet-rich plasma, which makes sense. They shouldn’t regulate, and they realize this, putting a person’s body back, regulating, say, for an example, a tissue or a skin graft or regulating transfusion of blood. That’s the purpose of this.

As providers in our O-Shot, and Priapus Shot, and Vampire Facelift provider groups, we insist that people follow these guidelines where we’re keeping records, we’re gathering data on our patients, but any formal studies that we do outside this area of just individual medical records that we’re keeping track of and keeping track of what we’re noticing, then we can actually be smarter about designing the IRB-approved formal studies where we perceive prospectively like we did with our lichen sclerosus study. Hopefully, that helps. I’ll put links to these documents below the video. I hope you find this helpful.