Accent Your Beauty

Watch video!

More about Dr. Berkowitz

Vampire Facelift® plus Altar™ …From where did it come? This Berkeley researcher tells all

This nih-Harvard-Berkeley researcher tells all…


Charles Runels: So, we’re honored tonight to be here with Kryz Bojanowski, Dr. Kryz Bojanowski, PhD. — who was the inventor of the patented ingredient that makes Altar™ cream what it is, that makes it not like anything else on the planet. So, thank you for talking with us Dr. Bojanowski. We’re here in southern California, and it was quite a journey. Two and a half hours for Dr. Bojanowski traveling to be here to talk with us about this cream.

Now, this cream came out of, not a frivolous project. I know that there was some study about how to treat some of the complications of diabetes. Will you just talk with us some about, what was the idea that prompted the development of the main ingredient in Altar cream?

Kryz Bojanowski: Yes, so, we started of by studying the diabetic skin as a model for accelerated aging. In the human body, the people with diabetes have an accelerated senescence of their skin, and it’s the perfect model to study the wound healing, because those people get wounds much more easy and it’s more difficult to heal them. So, me coming from a perspective, from a background of studying wound healing and skin vascularization, I was compelled to develop a product which would help skin of diabetic people, which will translate into an anti-aging product in general.

Charles Runels: Talk to us more about your background. How were you educated and how did you come to be studying this process in the beginning? What’s your story?

Kryz Bojanowski: Well, it started once upon a time, I was studying molecular cancer from oncology and my PhD is in molecular and cellular oncology of cancer. I spent 6 years in the University of Paris, studying the processes which are related to development of cancer, to regenesis, and how to control those processes. This brought me for postdoctoral training to Harvard Medical School, where I continued this cancer research. I specialized most in skin cancer treatment, and finding new treatments for skin cancer.

From there, when I moved to California, I worked at Lawrence Berkeley National Lab for some time, studying genes especially, and cancer cells, normal cells, skin cells, and from there it was only one small step to really getting involved in the wound healing, in the skin regeneration processes, which basically implore the same mechanisms than cancer, actually, except that it’s for a good purpose as compared with cancer which are suppressed, and out of control.

In the wound healing, in the skin regeneration processes, those are controlled processes that the body controls better if you can put it on the right direction. So, I was fascinated by this apparent parallel between wound healing and cancer. I wanted to understand what are the differences which make them, so similar yet so different, and different outcomes. We found out that there’s a big need for compounds which will accelerate wound healing, and which will accelerate the skin regeneration, either with, or even without wounds. In diabetic patients, people have wounds, but even without wounds, their skin is deteriorating much faster than in normal people.

Charles Runels: It’s easy to tear?

Kryz Bojanowski: It’s easy to tear, it’s easy to get some micro crack, which will develop in the hard to heal process. We were looking for a compound which can, first of all, prevent this from happening, because, you know, prevention is very important. It’s much easier to prevent than to treat what’s happened. Yet, when the things really happen, how can we can stop the degeneration process? How we can stimulate the wound closure and healing?

We found out that there is a process called angiogenesis, which is growth of blood vessels, which is very important for the proper healing of the wounds. Diabetic people have a very poor continuous circulation, very often. This is a factor which place in the difficulty of their wounds to heal.

So, we looked for compounds which can support the growth of blood vessels, which can support the stability of the blood vessels, because blood vessels may be leaking, can be not strong enough, can break, can have hemorrhages. This is what basically happens in cancer, the blood vessels are very leaky, and this is one of the factors that I worked on, how to make the blood vessels more, in French you say, [French phrase], less prone to leaking.

Charles Runels: Okay.

Kryz Bojanowski: We realized that this can have a very important implication for healing of wounds, and for the skin regeneration in general.

Charles Runels: Right.

Kryz Bojanowski: When the density of blood vessels decreases in the human skin, and with this decrease you also get a decrease of oxygen being transported to the skin. You cannot evacuate the metabolic waste, the cells become senescent, and all those are factors which play a big roll in skin aging and in the ability of healing of wounds in diabetic skin, and not only diabetic skin.

So, we developed this product. You know, we screened a lot of natural compounds, because it was important for us that it was a natural compound. We had a kind of, what is called HTP platform [inaudible 00:07:29] screening platform, which allowed us to zero in, isolate a couple of [inaudible 00:07:38] candidates, which we then tested on several different animal models, enzymatic models. We grafted human skin on mice and we wounded the skin, and we looked how the skin heals the wound in the presence of our compounds.

Charles Runels: So, is that the platform you’ve referring to?

Kryz Bojanowski: Yes, actually, the platform is multi-level. First you have the screening platform, which is in vitro platform in the kind of 96, in 96 well agar plates.

Charles Runels: Okay.

Kryz Bojanowski: Then you select couple of compounds which are the best being the most hoped-

Charles Runels: So you have tissue growing on a plate? You have cells growing-

Kryz Bojanowski: We have cells growing on the plate, yes.

Charles Runels: Okay, beautiful. So they’re? Okay.

Kryz Bojanowski: Then you look at the processes which happen in those cells. You can measure those processes by measuring the expression of genes. There’s the technique of PCR, polymerase chain reaction, which was used for that. You can use enzymatic analysis, you can use immunoflorescence, you can use lot of techniques to zero on the compounds which are the most promising ones.

Charles Runels: Okay.

Kryz Bojanowski: So, from there you go to the next level, which is animal study. We use either genetically diabetic mice, which are genetically prone to diabetes, they develop diabetes after a certain time, or you can use immunodeficient mice, which don’t have their own immune system, so you can graft the human explants from the surgery waste material, on them, and then you can work on those human skin splat supported by the animal.

At the end you have the patients to whom we give this compound, and they put it on their skin. We formulate it, and they put it around their wounds, and that was the ultimate level of validation.

Okay, so after validating the most promising compounds in the cellular model, we transitioned to the animal model, and for that we needed grafts from National Institutes of Health. This is a very expensive study, it’s a series of studies. It requires sophisticated angle of strengths, which are genetically diabetic, or which are immunodeficient.

So, after validating the most promising compounds in those animal studies, we formulated this molecule, and we applied it to volunteers under the supervision of pediatric doctors or family doctors, or doctors who are responsible for patients with diabetes, ‘diabetologists.’ They gave this product to the patients to apply on their skin, and around their wounds. We did several types of measurements. We measured the skin oxygenation, because this was the most important thing that we were looking for; whether or not this cream allows a better oxygenation, better vascularization of the patient’s skin. We measured the transepidermal water loss to see if the barrier function of the skin is improved with this product. We measured skin elasticity, and what else? The skin thickness. All those parameters turned out to be increased by the application of the product after 15 to 30 days.

So, the skin was more elastic, the skin was more oxygenated. We used a very sophisticated partial oxygen pressure meter to measure the oxygenation of the skin. The transepidermal water loss was decreased. So, we got all the parameters improved that we were looking for. Then, and only then we decided, okay, this cream, maybe now, put forward to see the world and to be commercialized.

Charles Runels: Beautiful. So, that whole process took how much time? From the time that you started testing on the plates, is that where you would mark the beginning? Or before that? Before that you had to think about what to put on the individual plates.

Kryz Bojanowski: Yes.

Charles Runels: How did you come up with the list of the things you tested?

Kryz Bojanowski: Well, we looked mostly for compounds which make up some merit, or make up some hope to improve the circulation. This was not a very kind of straight forward thinking, because when you look for skin products and skin additives, you don’t really think about the circulatory system more about your epidermis, dermis, keratinocytes, fibroblasts, skin cells. But here we actually took a more kind of holistic, more wholesome approach and we looked for compounds which may be beneficial for the blood circulation in general.

Charles Runels: Mm-hmm (affirmative)

Kryz Bojanowski: And so we looked for medicinal plants which have some track record of benefit for heart, for blood vessels, for bleeding, things like that. So one of those compounds turned out to be isolated from a Chinese medicinal plant called Angelica sinensis, which is considered in Asia to be like an equivalent of ginseng usable for the female part of the population.

Charles Runels: Mm-hmm (affirmative)

Kryz Bojanowski: And I learned that actually this compound and the plant where this compound is prevalent is taken by one who have a prolonged menstruation which cannot be easily naturally stopped, they continue bleeding and so we rationalized that this bleeding may be due to the fact that the blood vessels cannot be sealed, cannot be healed. And that’s why the bleeding continues.

So we were looking for a compound which is going to make those blood vessels stronger. So I immediately thought this may be a good candidate for our search. And indeed, we did our first studies on the micro-circulation in vitro. You can make a kind of three-dimensional network of blood vessels, using capillary blood vessels which you can make. But after a couple of days, those networks, they are outside of the body, they will fall apart.

And so we use this experimental system to study those different compounds to find out which compounds can support this network, to extend the life of this network, make it more kind of robust. So this is how we isolated our most promising lead candidate. And from there we did these annual studies and then we get to formulate this compound.

Because especially for the skin care, the compound itself can be very good but if it does not penetrate inside the skin, it’s useless. So it also has to be not irritating because the kind of very nice compounds which work very very well in vitro, and in vivo when in animal models, but when the patient puts it on the skin says, “Ooh, it stings,” and it is not comfortable. And so it’s not going to use it even if it’s going to provide the patient with a benefit.

So we formulated this compound, encapsulate it in a way that it’s not going to make the skin irritant and it’s not going to make the compound irritant, it’s going to provide penetration into the skin. So these were all those factors which we had to take in consideration beyond the active molecule that we developed.

Charles Runels: So I think you just partially answered this question, but for example, you can have a foxglove that becomes digitalis [when you isolate individual compounds and concentrate them from the foxglove plant], or you can have [the leaves of the willow tree that become] aspirin. You can have natural products or you can have the distillate … what’s the chemical that becomes … yohimbine [becomes Yocon]. But then if you get a very discrete, if you get a very nice isolate of it, it becomes a prescription drug, it becomes Yocon, which they took off the market when Viagra was approved.

It was actually a very good drug because it was a very concentrated isolate of yohimbine. So back to this product, what is it exactly that you did that made that natural product become more medicinal, more concentrated, less irritating? Did you change it biochemically, did you capsulate it somehow? What did you do to it to make it more medicinal and less like the natural root?

Kryz Bojanowski: Right, yes, that’s a very good question actually, because the answer is, we did both.

Charles Runels: OK.

Kryz Bojanowski: So first we isolated some fraction of this plant, of this root. And we refined it to the point that there were only very few molecules and only the molecules that you want there.

Charles Runels: OK. By a distillated process, or how did you isolate it?

Kryz Bojanowski: It’s a multi-step process, mostly by chromatography,

Charles Runels: OK.

Kryz Bojanowski: By filtration,

Charles Runels: OK.

Kryz Bojanowski: By affinity chromatography,

Charles Runels: Yeah.

Kryz Bojanowski: So …

Charles Runels: ‘Cause this detail, sort of science, is the kind of step that you might … this is what you do in a day. But when people look at this product they might not have any idea what you did that took this natural root and turned it from foxglove into digitalis but so to speak metaphorically, you took a natural product and you turned into something much more usable and more effective.

So what you’re saying is by some multi-step, sort of through pass chromatography and some filtration systems, you took different chemicals that were in this natural root and you isolated a particular part of it that seemed to be doing most of the work, is that what you’re saying?

Kryz Bojanowski: Yes, yes. It was fractionation, which was based on biochemical properties of the different ingredients in the root…

Charles Runels: OK.

Kryz Bojanowski: And it’s called bioactivity-driven isolation.

Charles Runels: OK.

Kryz Bojanowski: So basically to start with, it’s kind of very difficult to isolate compounds from a botanical that you are sourced because it’s so full of molecules. Life is full of molecules. So we needed to design a method which would allow us to be guided by the bioactivity, to gradually isolate the less and less amount of the smaller and smaller fraction of those molecules from the root to the point that if you remove one it’s not going to work or it works less.

Charles Runels: Yes, so as simple as it needs to be with no more simple than that.

Kryz Bojanowski: Right, so it’s a kind of fine balance.

Charles Runels: Yes.

Kryz Bojanowski: So if it’s too much, you are going to tag along some compounds which may not be desirable.

Charles Runels: Yes.

Kryz Bojanowski: If you purify too much, you are going to lose activity. Because very often in life, things are happening well because of one molecule.

Charles Runels: Yes.

Kryz Bojanowski: Very often it is combined activity, synergistic activity of several compounds which basically make things happen. So our pharmacological approach to medicine is basically purify one molecule, make it as pure as possible, make it into a drug, which, intellectually speaking, no, scientifically speaking, is very accurate. But very often you pass, you miss some activities which could be much better if you could leave a couple of compounds together. It would be a not so much defined product but still very, very useful.

Charles Runels: OK.

Kryz Bojanowski: And so we decided not to go all the way to the pharmacological grade of our preparation, which would allow us to file NDA and get a prescription medication status because we would lose this, at least partially, this activity which is contained in a multi-component preparation. So we stopped at the kind of border between multi-component and pharmaceutical grade.

Charles Runels: So I’m taking it that you can test it both sides of that line to figure out where to stop, is that correct?

Kryz Bojanowski: Yes, yes. We of course did many isolation repeats. It was a kind of trial-and-error process and that’s why it took such a long time, six years, right.

Charles Runels: Yeah.

Kryz Bojanowski: So we finally ended up with this minimum necessary amount of compounds which are going to provide optimal activity for the blood vessel support and the skin regeneration.

Charles Runels: Six years.

Kryz Bojanowski: Six years.

Charles Runels: Yes.

Kryz Bojanowski: Yes. And it could have been much longer if we didn’t get the support from the government, from the NIH, so that was actually quite big support.

Charles Runels: Meaning that you had other people helping you with the study.

Kryz Bojanowski: Well, there was a funding from the National Institutes of Health because we also developed a wound dressing which is a companion to the skin care product. But also of course I wouldn’t be able to do it by myself, I mean, these scientists, they don’t work solo. They have teams. So I was fortunate enough to have a good team of colleagues and technicians who really put their energy and their heart into this project.

So once we had this multi-component botanical isolate, we needed to formulate it in a way that it’s not going to be irritant to the skin of the patients and which will allow the active materials to penetrate into the skin. And that was another challenge. It’s actually often underestimated how much effort has to go into formulation of those active materials for the skin.

So most of the skin care products, they are called oil-in-water emulsions. So basically you have the lipophilic compounds which are surrounded by the water like film. And we took an alternative approach. We actually got a water-in-oil formulation which is more difficult to make, which takes more effort and more research to standardize, but which allows you to have a kind of packaging which is friendly to the skin.

Because skin is mostly composed of layers, right? So you need a like packaging which is going to interact with the stratum cornea which is this upper layer of the skin, of the epidermis, to allow the compounds to be then kind of introduced into the lower layers of the epidermis and even to the dermis.

So this water-in-oil solution allowed first the oil to contact the skin and then kind of dissolve into the oil, lipidic membrane, and then allow to introduce the active compounds which are water soluable, inside a skin.

Charles Runels: So the oil acts as a carrier to allow the aqueous part to then penetrate behind it somehow, is that-

Kryz Bojanowski: Yes, yes, that’s correct.

Charles Runels: So what you’re describing now is the formula for what’s the other ingredients in the package, Altar™, is that correct? This formula for the water and oil is the thought process that went into the other ingredients.

Kryz Bojanowski: That’s right.

Charles Runels: Can you specifically tell me some of the things in the list that accomplish what you just talked about?

Kryz Bojanowski: Well, as you can see, there’s a lot of compounds.

Charles Runels: Yes.

Kryz Bojanowski: And there’s a story behind each of the compounds.

Charles Runels: Yeah.

Kryz Bojanowski: And so, for example, the Dimethicone is FDA approved skin soothing compound. There is a, how do I say… This is a very interesting compound between what we worked separately on and we found out that the hydrolyzed silk, basically it’s a protein. And this protein is very good at simulating collagen expression. Now we go back to the laboratory studies. One of the studies that we did is to assemble some of those components and put them on the skin and measure gene expression in the skin. Basically, by measuring the gene expression you have a genetic print out of the… You learn what is the genetic response of the skin to the formulation that you are planning. So this is also something that we did it, the time that we did it was very unusual to do, because you don’t look at 70,000 genes; that’s the amount of genes we have in our body; enough to formulate a skincare product, but we did just that.

We did what is DNA microarray study which allows to measure the expression of every single gene in the tissue. So in our case it was steep and we measured, we quantified the expression of those genes with or without our formulated product.

Charles Runels: With the hydrolyzed silk?

Kryz Bojanowski: With the hydrolyzed silk, yes. And we found out that hydrolyzed silk adds to the benefits of the angelica sinensis extract. So that’s what only some of those share but it’s a very good oil which provides an lipihilic kind of environment.

Charles Runels: So is that part of the care here you’re talking about?

Kryz Bojanowski: It’s a part of the care. It’s not just like two compounds that you would, it’s not like two level blocks that you put together. It’s more like a meshed entity. It’s a kind of integral structure which is formed between a few compounds which are towards the outside with the formula becoming hydrophilic when you get inside the formulation. The formulation you can think about, that’s about like liposomes or micelles and that’s like an ingredient of hydrophobicity from the outside to the inside. Different components occupy different layers in this grid.

Charles Runels: So I noticed when I use it, that it does have an exceptionally just smooth, pleasant feel to it. Is that what I’m feeling? That sort of lipolytic outer layer, the aqueous, what would you attribute to the fact that it just feels very soothing? Is that the whole recipe-

Kryz Bojanowski: Yeah, it’s like chef cooking a special dish!

Charles Runels: So how many years did you work on this recipe?

Kryz Bojanowski: Well 6 years of actual testing.

Charles Runels: Just on the one ingredient?

Kryz Bojanowski: On the one ingredient. Well we did it testing in parallel in several ingredients. So if you add all of the years of experience, of work on each of the components, it’s going to be probably close to maybe half a century.

Charles Runels: Are you half a century?

Kryz Bojanowski: Half a century?

Charles Runels: Are you a half a century old?

Kryz Bojanowski: Well that’s actually I am getting there.

Charles Runels: I think so to be plain that this is not a lotion that you cook up at the local dime store. This has a lot of thought that you’re allowing us to make it part of our procedure, because I think we have an amazing group of doctors working– we are now in over 50 countries and it’s about 2,000 of us–really brilliant physicians in multiple universities. And I’ve had a lot of people bring stuff to our group that I’ve said “no” to for 8 years. It went from nothing was good enough for us to now I’m actually honored that we’re able to offer this as part of our procedure, because I think it obviously it contains a big piece of the life of a brilliant man built into it. So I’m very grateful that-

Kryz Bojanowski: The honor is the product. I also feel that this product really fits perfectly into your strategy, because of it effect on the strength of the blood vessels; and also in the skin, the regenerative, the healing potential on the skin, which I think is going to be very well matched with your products. Which needs to be introduced by puncturing the skin gently and this product is going to allow those patches to go away in no time. I think it’s the perfect match.

Charles Runels: Yes! When we use PRP, we have biopsy studies that show the PRP causes neovascularization, fibroblast activity, and the idea that we now have a cream that does the same thing at the same time–it’s no wonder that we’re seeing really miraculous results. We have other procedures, other than facial procedures, that we’re doing. For example, we have a procedure where we use PRP therapy [Vampire Wing Lift™] to regenerate some of the appearance and the function of the labia and some of the sexual tissues. Anecdotally, some patients told me that even post waxing the labia using this has a calming effect and a healing effect. Waxing can be pretty brutal to the skin or just shaving. Post shaving the labia where the tissues are so fragile, using [Alter™] afterwards can have an amazing effect.

Just think about the drugs. You do thousands of test and millions of dollars; and you put it in the hands of the consumers, and they reflect back at you because there’s a sizable number of people using it, and then stuff you haven’t thought about starts to be known. It’s going to be fun over the next few years to see what happens when we put it in the hands of our providers and in the hands of thousands of patients.

Kryz Bojanowski: Yes, I feel like my baby grew up and left the house. I don’t have control of it. But it’s interesting what you said about the shaving; because it comes back to this idea of the female ginseng I think that in Asia, this plant is being used by the female population predominately. Maybe because there are some specific benefits to the gender.

Charles Runels: I need to be careful. I’ve been putting it on the scrotum and the penis. I just need to tell you right now. For me that’s important that that stays healthy too. If you’re gonna have fewer older cells, why not put it on your penis. So I’ve been putting it on my scrotum and my penis and I think its happier-

Kryz Bojanowski: Well it’s skin. You have skin, wherever you have skin.

Charles Runels: So this plant from which the isolate is made, are we going to run out of that? Where does it grow? I haven’t seen it growing… obviously it’s in China and it’s in other places. Are we going to say “oh this product is wonderful” then all of a sudden we can’t get the plant anymore.

Kryz Bojanowski: That’s a good question because I was referring to a female ginseng. It’s not like ginseng which you have to go to the mountains to hunt-

Charles Runels: Which I’ve done before. It’s very hard to find.

Kryz Bojanowski: So this one is actually cultivated. It can come from organic fields. So it can be certified organic. There’s a control over the supply. We don’t need to worry about that.

Charles Runels: Good. Glad to hear that. I’m really honored to talk to you. I think that’s all the questions I have for you. I’m going to invite our providers to write in and blog, and the people who use it, to let us know. Hopefully they’ll teach us more about your baby. What it could be used for. I do think it’s going to take a life of its own. I’m really grateful to you for thinking it up.

Kryz Bojanowski: So, I give it to you now.

Find Provider of Vampire Facial® and Altar™ Cream
Find Provider of Vampire Facelift® and Altar™ Cream
Apply for training to become a provider<–

Vampire Facelift® vs. Vampire Facial®. The Difference Between the Two Procedures


Vampire Facelift® Official Website
Vampire Facial® Official Website
Apply for Training for the Vampire Facelift®
Apply for Training for the Vampire Facial®
Altar™ (A Vampire Skin Therapy™)
More about Dr. Charles Runels

Charles Runels: Hello, I’m Charles Runels, the inventor of the Vampire Facelift®. I received a letter today that had a thoughtful question, so I thought it might be helpful to read to you the question and answer it for you. In the process I’ll explain to you what the Vampire Facelift is, the difference between the Vampire Facelift and the Vampire Facial®, and how to receive training, how to know which one you should be trained on, and how to find the best provider, and how to know which methods, devices, and materials you should use.

So here’s the question…

 I am interested in becoming a provider of the Vampire Facelift. I wanted to ask you if you felt that the facelift works better with the use of the micro derm-abrasion pen, or with injections. Do you feel there is a difference in the results? Thank you for your time.

So first of all, how this came to be, I think that will help you understand the procedure. I don’t like the fact that if you see advertisement for, let’s say, Juvederm, or Restylane, then you don’t really know the method that will be used. For example, if you see an advertisement for beef or pork, but you can’t tell if it’s a fast food restaurant or a gourmet restaurant, that would not be so useful. You see the name of the restaurant, and then you assume that materials and the methods used will be excellent, or not as excellent based on the name of the provider of the food. Unlike that, if you see an advertisement for, let’s say Juvederm, you’re not sure if the provider is of excellent quality or not. At the present moment in the United States there is no board exam where people are tested in detail about the methods of injecting facial fillers. Surprisingly, no board exam claims it.

So, you have sometimes facial plastic surgeons who are excellent, but yet sometimes you go to the facial plastic surgeon’s office, and it’s a nurse practitioner who’s doing the procedure in a very excellent way, or a family practitioner who does amazing facial cosmetic injections, sometimes better than the other specialty that might be down the street. So there’s really no way to know looking at the board exam, or by looking at the material you use, whether you will come out of there having either duck lips, or sausage lips, or a very natural beautifully restored mouth.

So, because of that, when I developed the way of using platelet-rich plasma in combination with facial fillers, then I wanted a name that meant the way it might be used in the most excellent way. So it should define how the fillers should be used, and how the plasma should be both prepared and used in combination with those facial fillers. Now, obviously I can’t be in someone’s office every time they do a procedure, but what I can require is that if someone is licensed to use the name Vampire Facelift, they at least demonstrate an understanding of some basic principles that I think are required to provide an excellent procedure.

For example, they should be using a platelet-rich plasma kit that’s approved by the FDA as a device for putting plasma back into the body. The FDA does not evaluate or approve any procedure, whether that be a hysterectomy, a cholecystectomy, any kind of C-section, there is no procedure that the FDA approves. It’s the F, food, D, drug and devices administration. Food and drug administration, but that includes devices, but it’s not the food and drug and procedure administration. They do not evaluate procedures. Physicians do that. The FDA is neither qualified, equipped, or determined to in any way regulate that.

So, having said that, the FDA does and should evaluate facial fillers, and has approved Juvederm and Restylane as a device that can be injected to create cosmetically appealing shape in the face. Now, what happened was, when I used the facial fillers, being lucky enough to study with some amazing people around the world, I was able to develop a technique that I think creates a natural and younger shape a large percent of the time. A large percent of the time, almost all of the time, without creating anything weird or any weird side effects. It’s a safe way to create a younger natural shape. So, everyone who is certified by the Cellular Medicine Association, which is the organization that started to help regulate and think about these ideas, which has garnered amazing input from brilliant brains around the world.

So, using our collective mentality, we come upon ways that we modify and make better, based on research and ideas from the group, which includes many professors of many medical schools around the world, and we come up with a way to do something, and then everyone in the group agrees to follow that method, modifying it as needed based on what that individual patient might demonstrate in the office, but always maintaining certain standards, such as using an FDA approved kit to prepare the plasma, by using an FDA approved hyaluronic acid filler, and using an FDA approved micro needling device when doing the Vampire Facial.

So here’s the difference between the two; if you go here, this is the website for the Vampire Facial, and you’ll see that I’m using a micro needling device. This is me doing a procedure, a Vampire Facial, on Yasmin, a beautiful reporter there for CNN News. Here’s photographs you can see of Kim Kardashian where she had her Vampire Facial, she had it while she was pregnant, she recently blogged about this again, and much of her pain was because she’s tough enough that even though she was not able to use the numbing cream because she was pregnant, she went ahead with the procedure because of her intention to have it as part of her television show. So the procedure, which is normally minimally uncomfortable, was more painful for her, but a nice point about that is the plasma itself was safe to use even while she was pregnant, because it’s her blood. There’s never been a serious life threatening infection or brain neuroma from platelet-rich plasma.

So you can see that other amazing, gorgeous, and brilliant people have had the procedure, like [inaudible 00:07:23], and Giselle, and other, if you go online, many other movie stars, because this is a beautiful safe way to create colored texture changes. So, obviously you can see Kim, she’s young here, and she’s full of hormones, and Ms Kardashian, as a pregnant woman, had a beautiful shape already. So the facial was the perfect procedure for her. Facial meaning using a combination of micro needling with platelet-rich plasma applied on top of that, and now we add to that procedure by using a patented material that is in our Vampire Skin Therapy cream, called Altar, A-L-T-A-R, as in your body being a holy temple, and then using Altar immediately post procedure you get a more rapid healing from the micro needling.

So the Vampire Facial is prepare platelet-rich plasma, use micro needling, apply platelet-rich plasma both during and after the micro needling, then apply Altar, and then you go home. And what you see is over the next week to six weeks, full effect is probably eight to twelve weeks because you need collagen production. The micro needling causes channels, those channels heal in, just as they would if you did a fractal laser, one without the threat of burning, and you can use it with all skin types. So doing that, we have split face studies showing we can help acne scarring, we can help colored texture, but you don’t do that much for shape. So if you have cheeks that are going flat, or if you have a mouth that’s turning in, then the Vampire Facial would not be the procedure. For that, you would do the Vampire Facelift.

The Vampire Facelift, which you can see here, is a combination of using a hyaluronic acid filler, like Juvederm or Restylane, to create a beautiful shape, and then you take the platelet-rich plasma and you inject it subdermally, so you go under the skin. The reason we call it a facelift, as opposed to a facial, is that HA filler goes under the skin and lifts the skin away from the skeleton of the skull creating that beautiful natural shape you had as a child, or a teenager, or closer back to that shape by lifting the skin away from the skull. Then, the PRP recruits stem cells to the area from your own bone marrow, so the PRP releases active growth factors and cytokines from the platelets when it’s injected subdermally, then those pluripotent stem cells come to the area and then mature into collagen, blood vessel, nerve, and the HA filler acts as a substrate, or a scaffolding on which that grows. It creates a very beautiful, natural shape. We still like to use our Altar cream to enhance that effect.

The SBD-4, which is in Altar, has been shown to decrease the number of senescent cells, so in biopsy you can tell which cells are old and which cells are young, and the active ingredient in Altar, SPD4, causes an increase in numbers of the younger of the cells, along with the cytokines and the growth factors, over 20 of them in platelet-rich plasma, causing new cell growth, new collagen. There’s a really amazing, amazing synergistic effect, and sometimes we’ll even add amnion to the PRP for an even greater effect, from the peptides that are in amnion that cause even more astounding effect. So there can be a synergy base in all this.

Now, this is not going to make 80 years old look 18, but if you have the Vampire Facelift you should leave the doctor’s office looking younger and still looking natural with a more youthful shape, and you’ll get colored texture changes. You can get a more dramatic change for things like acne scarring and crepe papering under the eyes with the Vampire Facial, but not much change in shape. You can get a very dramatic change in the shape with the Vampire Facelift, but not as dramatic change in the crepe papering under the eyes.

So, a little more about who can do these procedures. The facial, because there’s no injecting subdermally of the HA filler, there’s micro needling and topical application, varies from state to state and from country to country, but the skillset and the licensing required is usually less stringent. In many states a esthetician, in most states actually, an esthetician can do the micro needling, but handling the blood, usually in almost every state and country, now you involve an RAN usually, or a physician’s assistant, or a nurse practitioner. So, but because there’s no subdermal injection of a filler, the skillset involved is different and less stringent with the facial.

Now, with the Vampire Facelift, because it involves injection of Juvederm of Restylane, the licensing varies, and it should be and it is, more stringent, because you’re if you’re not sure what you can do, you can hurt people with a filler much more easily than you can applying PRP topically. To hurt someone with PRP topically you have to do something stupid and get people’s blood mixed up, which we just don’t do. But for injecting fillers, if you’re not sure what you can do, you can create a weird shape, and you can also cause serious problems like skin necrosis, and even blindness. So you have to know what you’re doing.

Now, the licensing requirements for the fillers varies from state to state. In Alabama you have to be a licensed physician. In most states though, a well trained RN or nurse practitioner can inject fillers. Nurses and physician’s assistants often do extremely dangerous things, like I.V.s, and pushing I.V. drugs that could be life threatening if done wrong. So in my opinion it’s extremely reasonable for an RN to be able to inject fillers, but they need a different level of training, and we are very strict about following the licensing guidelines of the state. So in Alabama, where at the present moment an RN cannot do fillers, there are no Vampire Facelift providers, but there are Vampire Facial providers, because the facial’s micro needling and PRP, the facelift is subdermal injections of the filler followed by subdermal injections of PRP.

So, if a provider is already skilled in Juvederm, or Restylane, or some sort of subdermal hyaluronic acid filler, they can easily learn to do the Vampire Facelift by learning to do the plasma portion of it, which never creates an odd shape because it’s growing based on the man or woman’s genetic code.

Now, if you are a provider then, hopefully this is the answer to some of your questions, and you’re trying to decide which procedure you would like to learn to do, I recommend that you do the facelift if you are proficient in fillers, and the facial, because you could vary the procedure based on what you’re seeing. If you’re not already proficient in using the fillers, and your state allows you to learn that, then I recommend a hands on course. It’s possible for someone who’s already proficient in fillers to learn the Vampire Facelift, as in the PRP portion of that, using our intensive online training materials, with testing following. The facial is if you are a licensed RN or physician’s assistant, the last we checked, check with your state, but the last we checked every state in the United States and most countries will allow an RN or a physician’s assistant to do the Vampire Facial. Some countries are more particular about the platelet-rich plasma portion of this, so check with your country and check with your state to see if something has changed with that recommendation.

Now, if you are a patient, this is very important. If someone’s advertising the facelift, and they’re not listed as a provider on this site, so if you go to and you click on ‘find provider’, if they’re not listed in this site, they may be doing wonderful work, but they have not been licensed by the Cellular Medicine Association, and so they may not know our methods. So here’s the countries that we have people in at the present moment. We have almost every state, we have people listed, and you can search by zip code and it will list people by nearest to farthest. Obviously it’s listing me first, because I’m the closest person to me at the present moment. But it will list people nearest to farthest from where’ve you’re sitting, or you can put in a zip code and find it.

So, this is where you go to find someone who understands, and has agreed, and has been licensed to use the name, and they understand and agreed to use an FDA approved kit to prepare the plasma, to use an FDA approved device, if they’re doing micro needling, to use an FDA approved hyaluronic acid filler, if they’re doing the Vampire Facelift, using the FDA approved micro needling device if they’re doing the Vampire Facial. Now, the micro needling is different than micro dermabrasion. Think of micro dermabrasion sort of like a scrubbing, sandpapering of the face, which is a nice procedure, but the Vampire Facial should involve micro needling. So you have 10 to 12 needles that are going at a very precise amount, anywhere from half a millimeter to two and a half millimeters. You can see it’s asking me now if it’s okay to know where I am so it can list people from nearest to farthest. So if you so micro dermabrasion followed by PRP, that’s not the Vampire Facial either. The Vampire Facial should involve using micro needling devices that are FDA approved.

Now, why do you need FDA approved? Because the old devices would sometimes pull blood up into the handle, which made them an infectious disease problem. So you should have a device that’s been approved by the FDA. If you ever needed the FDA to approve something, it would be a device that actual punctures the skin, creating both the dermal puncture wounds, and possibility of blood cross contamination. So make sure you find someone on this website, so you find someone who’s agreed to following these guidelines, because I promise you, I promise you, not all providers are following these guidelines.

So, if you’re a provider, you can go to these websites. Let’s say you’re on Vampire Facelift, you can go to ‘for physicians‘ and there’s a place there to give us your information, and we will give you information on how to apply for online or hands on training based on your qualifications. So the Facial has the same possibilities, you just go to, if you’re interested in becoming a provider you click on ‘for physicians’, and then you fill out the form. And we will send to you everything you need to know to find out if this procedure’s for you. So, thank you very much, it was an honor to spend some time with you. (for documentation of Dr. Runels ownership of Vampire Facelift® & Vampire Facial®) …type “vampire facelift” or “vampire facial” into the search box.  click for documentation<–

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
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

Cellular Medicine Association



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.






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..






and here<–

New England Journal Article about Stem Cells…
click <–

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


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.


Copyright - Disclaimer - Earnings - Privacy - Terms & Conditions
52 South Section St., Suite A, Fairhope, AL 36532 - 888-920-5311