The Vampire Facial®, Vampire Facelift®, O-Shot®, & P-Shot® are all “service marks.” Service marks are a particular type of trademark that indicates a very specific method of doing something.
The Cellular Medicine Association and Dr. Charles Runels (the originator of the “Vampire” procedures) license providers of the above procedures when providers receive training and agree to follow the recommended methods. This then gives the provider the rights to use the service mark to advertise the procedures. Then people who wish to have a procedure done can identify those providers who are licensed and so who have demonstrated an understanding of the best way to optimize results and minimize risks.
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.
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 (service marks) 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, licenses 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.
4. What are the health risks of undergoing the procedure?
5. Is there any data on how many people undergo this procedure in the U.S.?
6. How rare/common are incidents like the one that occurred in New Mexico?
7. Why did it occur?
Transcript
Charles Runels: Hello, my name is Charles Runels and I think due to recent events in New Mexico and all the press that's coming out because of that scare it is worth describing exactly what is a vampire facial, does this happen? Lots of questions coming. That's Rolling Stone. That's CNN talking about it and also on Fox News, all over the place people are wondering, what the heck is a vampire facial?
Is it safe and how did this happen? So first of all, who am I? If you go to the U.S. Patent and Trademark Office, uspto.gov, and you search trademarks, right there, and then you put in search a trademark and you put in vampire facial you will see that I own this name. So Vampire Facial, there you go and then you search and there I am. So Charles Runels, just so you know where this is coming from. Do the same thing for vampire facelift, which is not the same thing. Vampire Facelift and then you search and you'll see the same thing. There's my name.
First of all, before this came about, I was injecting procedures and I did not like that I would be saying I was doing Juvederm and another doctor saying they were doing Juvederm and there was no way to predict the results. There is still no medical board that claims cosmetic injections as part of their medical testing. Not the plastic surgeons, not the family practitioners. It's not part of a board exam. It's just done and it comes under the medical licensing. It should be done in the proper way and because of that, there's a variation in state requirements.
For example, some states like where I live, you have to have an MD to do these injections. In some states like Texas, you don't even need an RN degree. So it's all over the place about what's needed to be able to do. You can be an esthetician and do Juvederm in some states. So I didn't like the fact that I could be advertising Juvederm and no matter what the degree or letters behind someone's name, then when I did facial fillers and someone else did facial fillers, the level of expertise and the level of training was not predictable by what we were talking about.
So when platelet rich plasma, which has been around a very long time, this is PubMed and if you just do to PubMed, which is where most doctors go to research, there's over 10000 papers about platelet rich plasma, which is one of the two ingredients in a vampire facial.
That's been around a long time and it started to come on to the cosmetics scenes mostly used for healing scars, healing hard to heal tissue. It's what the body makes when there's an injury and over 10000 papers there's not one serious side effect or infection. It's what your body makes to heal tissues. So it would be like saying your suffocating from oxygen. Nobody gets a serious infection from PRP because it's coming from the person's own blood. So the process is you draw blood, it goes in the centrifuge and then that centrifuge, which should be FDA approved for preparing blood to go back into the body, a modern kit that's made for analyzing blood, that device should be approved by the FDA for preparing blood to go back into the body or plasma to go back in the body.
That's then processed, put back into the person's own body. So we do blood transfusions all the time. As an E.R. physician, we handle blood all day long, every day and there was never even worry about it as long as you follow the right processes of taking blood from one patient to the other because you follow the right protocols. So using kits that are FDA approved not for a particular procedure for preparing the blood, the blood actually belongs to the person. So the FDA does not approve a person's blood.
Let's just get that off the table. Now, the FDA doesn't approve your spit, your urine, your hair, your skin or your blood. That is not a drug. The food and drug administration governs drugs and devices but if a physician uses a instrument that's not made to prepare blood to go back into the body and instead uses a lab kit, which is a lot cheaper, to put blood back into the body, that is second rate medicine.
So I did not want the same unpredictability that goes along with injectable fillers and Botox to be applied with blood. So from the very start, when I came up with an idea of using platelet rich plasma to go into the face and combining it with expertly done fillers, either Juvederm, Restylane or one of those FDA approved liquid collagens, I wanted the process to be predictable. Even with the same physician it's not exactly the same results with every patient. Faces vary but at least the ideas of safety and protocols and the ideas of aesthetics should be understood by everyone doing the procedure. So that's why I went to the Trademark Office and I patented this not to mean a material but to mean a process or a way of doing things. Now vampire fillers out there, vampire therapy was being used to mean using PRP in the face. But when I first used this word or phrase, vampire facelift, that compound word had never been used.
You could Google it in quotations marks, it did not come up and so that meant the combination of using PRP with done in using the FDA approved kit in the most sterile way, the way that physicians and people who are used to dealing with blood know how to use it. Doing that in combination with expertly used Juvederm. Now, in the same way, using PRP in combination with micro needling means the vampire facial. So vampire facelift is a way that's of using Juvederm or Resilin or one of the FDA approved liquid collagens and then using that as a substrate and then putting PRP on top of it. That's been used in wound care for a very long time and you can see that research if you go to vampirefacelift.com and look on the research page. You can see we're using an HA filler like Juvederm and then putting PRP on top of it helps heal hard to heal wound but it also helps rejuvenate the face.
So back to this thing, what the heck is a vampire facial?
This was meant to imply a method, not just any method but a very particular method that evolves with the research and has agreed upon by the members of this group. So it's not a franchise, it's not a material, it's a method and this trademark means, using this trademark should mean, that this person is part of our group. I own the trademark. I lease it out to the Cellular Medicine Association, which is our group of physicians who have agreed to do research and come up with very useful protocols for doing things like PRP also helps lichen sclerosus. We published in one of our dermatological journals how using PRP ... It didn't show up but you can go to our research page and find it. When it comes to lichen sclerosus or a very serious auto-immune process that causes problems with skin of the vagina, causes it to crack and bleed and cause problems. You can see where we've done research showing that it helps with that process.
This was published right here in American Academy of Dermatology and we had blinded the pathologists demonstrating benefit. So that's a very good paper.
and where we also spend hundreds of thousands on legal shutting down the people that are pretending to be us and even though I've been interviewed by the New York Times twice, very nice articles. I've been in Cosmo, I've been in the Tattler, I've been in lots of articles. We were recently, our procedure was recently in New Beauty. I've never seen, even though I've wanted it, I've never seen anyone stress the idea that this should be done by people that are in our group. We own the trademarks throughout for the O shot. We own the trademarks throughout Europe for the vampire facelift and the facial. We own the trademarks throughout the United States and throughout many other countries.
So if you go to say vampirefacelift.com or vampire facial, which is what we are talking about now and you look here in a very big disclaimer and this has been here for now almost ten years, I guess it's eight years now, you have this very big disclaimer at the top of the page.
It's protected by patent and trademark law...
and only people listed on our directory have agreed to follow our protocols and anyone else advertising it is stealing intellectual property.
They're stealing intellectual property. That means they're not ethical and anybody that's done this procedure has gone, you can't tell me they're not gone to the main website and looked at it. So they've read this big red letter thing here and if they're using it without joining our group, they know they're stealing. So by definition they're unethical so if you go here in whatever country or state you're in, you are ... If you want to find someone who's agreed to follow our protocol, I mean, these are top-notch doctors. Plastic surgeons. We spent half a million dollars on advertising ... Excuse me. A half a million dollars on legal, just in the past six months, shutting down people who are pretending to be us, trying to protect our reputation.
Unfortunately, there's so many people pretending to be us that we haven't gotten to everybody yet.
But we just sent out hundreds of cease and desist letters.
We spend thousands on lawyering because people realize it makes them money, and they drop their standards, and they use lab kits, and people who aren't even qualified to do it. Like here's one where someone died in a massage parlor. Not from one of our procedures, it turns out. If you read here, it was an illegal buttocks enhancement, which is very dangerous, often done with stuff from the hardware store. It's a very dangerous thing, and if you Google that, you'll see lots of people died that way. But this person was advertising Vampire Facelift. Illegal.
Now the only thing that makes that word illegal for her to use is that we own it. All these amazing physicians with reputations to hugely ... I just showed you the list, all these people on that list that have amazing reputations, they, whenever someone steals it, it would be exactly like they're using any other trademark name, like they were pretending to be part of the Mayo Clinic, or any other respectable clinic. It's hurting the reputation of us when somebody uses our good reputation and our hundreds of thousands of dollars in research per year, and using that good will and good reputation to trick people into coming into a clinic and having substandard medicine done.
So I have been spending out of the funds from this group of amazing physicians, hundreds of thousands of dollars trying to shut these people down. I'm very grateful, not for the misfortune, I hate that misfortune happened, but I'm very grateful that articles like this are calling attention to what the heck is a vampire facial? It's a very particular way of using an FDA-approved kit to prepare blood to go back on the face.
If you go to here, and you look at all these 10,000 papers, which I've read most of them, and I read all the review papers, you won't find any serious infections ever done. You will find research showing that it helps fight infection. So just go here and put in infection, and you will see that the dentists and the wound care physicians, they use it to help fight infections, in transplant, and all sorts of stuff. Diabetic treatment of a chronic wound. You can see this helping eye ulcers. You can literally put it in your eye for dry eye.
It's a very, very safe thing that's coming from the person's own blood.
So done properly, there is nothing in the room that has blood of anybody else on it, and everything is sterile, as it should be in a medical facility where you're dealing with blood every day, all day long. In every room of an emergency room where I worked for 12 years. So it's blood everywhere, all the time. But it doesn't mean that anybody ever gets cross-contaminated, because you follow the right procedures.
So all the people on our list of providers, if you go here, Vampire Facelift, or Vampire Facial, and you click Find a Provider, all these people have agreed to follow the right protocols.
We've turned down three people just this week, people trying to do our procedures who are not qualified. They apply and we say, "No, I'm sorry." Or, and then we had, I think 200-and-something letters going out last week, shutting down the infringers. So you can see a list of the infringers here. You can see some of the litigation we're under. Some of the people who sell the kits want to be able to use our name to sell some of the kits, that are FDA-approved, but then they want to use our name. Some of the sales people have in the past, and even currently, using our good name to sell the kit, and then they want it to just mean using plasma with that kit, and no particular method.
So that's kind of what this is. Let me go back and make sure I've answered this.
So how does the process work?
I think I covered that. We draw blood in a sterile fashion from the patient. It's put in a centrifuge made to process blood to go back into that patient in a very safe way. Then that person's blood is then put on the face, and then a device that's FDA-approved for doing this, now, you can buy these off of Amazon. And not all devices are FDA-approved. Some of the devices suck blood up into the handle. So even if you clean up the room, you've got blood in the handle of the freaking device. So, you want to make sure the device is FDA-approved, too. So then you do micro-needling, and if you go to the Vampire Facial website, that's the facelift.
If you go to the Vampire Facial, vampirefacial.com, and then you scroll down, you'll actually see me doing a Vampire Facial on one of the beautiful, Yasmin, one of the beautiful reporters there at CNN. You see what I'm having. I have gloves on. I have a device that is approved, does not suck blood up into the handle. It's completely closed off. I have plastic, or a disposable condom sort of thing that keeps any blood off of the thing, so that the only thing that's contaminated with her blood, which is not a contaminant to her because it's her blood. It's clean. So this gets thrown away, and then this is protected. Of course the gloves are thrown away, and then everything is gone that had her blood on it. The device is made such that the blood cannot be transferred from there to there into the handle.
Even still, the device is cleansed before it's used again, and then with the next person, there's new gloves, there's a new clean condom, a new, my tip, that's making multiple puncture wounds, about 80,000 puncture wounds a minute, about a half a millimeter to two and a half millimeters deep, and then the blood is applied topically. That's a Vampire Facial.
It's not just for cosmetic reasons. Before some of you say, "Oh, just age gracefully."
First of all, who says that about the house? I'm not going to paint my house, I'm not going to wash my car or wax my car. I'm just going to age it gracefully. That's Middle Ages stuff. Those old priests who thought you shouldn't bathe the body because you should be paying attention to the inner soul. Okay, take care of your soul, but take care of your body too, and don't make any excuses for it. So, it's okay to take care of your body as long as it's done in a safe way.
Over 10,000 papers ... One of the FDA kits alone, one of the FDA devices alone, they sell over a million tubes that are used to process the blood per year. So there are millions per year, probably somewhere in the neighborhood of 5,000,000 PRP procedures at least, probably closer to 10 PRP procedures per year worldwide, and never one, never one serious sequelae, ever. Not a neoplasia, not a serious infection, nothing when it's been prepared with an FDA-approved kit and done by a trained professional. Nothing, not one. Except for one incident when someone injected the eyeball. So don't inject the eyeballs. I don't know who got that crazy idea. Actually, I'm told it can be done safely in the right hands. Except for that one incident where an eyeball was injected, no serious sequelae yet, ever.
And it's not just about being beautiful.
Here, I know, because I had serious cystic acne. I know what it's like to have adults look at you when you're a teenager and ask you what's wrong with your face, because pus is running out of your nose, and people are too fucking ... Excuse my language. They're too stupid to know that as a teenager, that is painful emotionally and physically. Using micro-needling, we can fix those scars. It's been proven, you can read the research here, it's been proven to work better if you use our Vampire Facial procedure, where you combine the micro-needling with PRP. I'm sorry I lost my temper, but there's a lot of pain with having acne, and with needing to hide your face as a child. Not a few bumps, but serious cystic acne. It can cause horrible scarring, and our Vampire Facial is a way to fix that. We can also help keloid, we can help hair regrowth, and so this is an important advance, a very important advance in medicine that should be taken seriously.
So what other questions? What are the health risks? The benefits, we just covered some of that. It's aesthetic, it's hair growth, it's scars. For example, one lady I treated had horrible zoster, which is like herpes, only on your face, with left her horribly scarred, and she felt embarrassed to go to her granddaughter's wedding. Why should I not be able to fix that? And I see the blogs, and I know some of you guys would put on here, "Well, just age gracefully." Or, "Beauty is in the soul." Yeah, but this is our body temple, and we get to take care of it if we want to, especially if it's something safe. So the health risk of undergoing the procedure, 35,000 people per year die from gastrointestinal bleeding from aspirin and non-steroidals. No one ever, with millions of procedures done per year, has ever-
No one ever, with millions of procedures done per years has ever died or had a serious infection from PRP as a standalone [WHEN DONE BY SOMONE USING FDA APPROVED KITS AND PART OF OUR GROUP].
So the health risks are basically zero. I won't say there's no sequelae ... People have pain, they get bruising, things happen, but as far as a serious life-threatening thing like what happened here in this New Mexico thing has never happened one time with millions of procedures per year, so I don't know anything this safe. And the reason it's safe is we're using the person's own blood and that part of the blood that helps you recover from other procedures.
When you have surgery, the thing that helps you recover is PRP. When you scraped your knee as a child, that scab that formed that helped you regrow the new skin, that was platelet-rich fibrin matrix, which comes from PRP. So how rare instances like this occurred in New Mexico, well, I don't know, because what happened in Mexico was not one of our people. But I can tell you that this never happens with our people because we follow the right protocols.
Now I'm not up in everybody's office,
I can't watch over everybody's shoulder anymore than anybody that's a member of the American Board of Obstetrics and Gynecology. They don't have board members watching everything they do, but that board asks people to follow certain guidelines when they do a hysterectomy or pap smear, and if somebody's out of line, they get kicked out of the group. We've only had to kick one person out of our group, and there was no serious harm, it was just they weren't following our guidelines. So we don't let everybody in and we don't let everybody else stay in.
Why did this occur?
Because it was in the hands of someone who was not licensed and able. First of all, they weren't even licensed to be able to do ... handle blood, the best I can tell, the way they were doing it. But they weren't part of our group. So if you want to make sure that you're seeing someone who's able to do this, then ... and has agreed to follow the right protocols with using FDA approved kits, then you should click on Find a Provider and find somebody that's in our group. That doesn't mean others aren't doing it the right way, but I can promise you that the people in our group have agreed to do it the right way and they have the proper licenses for their state.
So in some states, it's perfectly acceptable for a nurse practitioner, or an RN, or a physician's assistant ... Physician's assistants help with heart bypass surgery. If you've got the right training, you can handle blood. It doesn't have to be an MD or a DO, but it needs to be someone who, in their state, is able ... The guideline we follow is, in their state, are they able to inject Botox and Juvederm or basically ... because you can get serious sequelae, from say Juvederm, can cause necrosis and blindness even if done the wrong way. PRP's never done that.
So if their license ... If they are able to get a license to use Juvederm in their state, we approve it. This person where this happened was not part of our group, and so the person it happened to might have avoided it had they only gone to someone listed on our provider list. I'm not blaming the victim, because apparently the people who are running this must have been pretty persuasive, they had a clinic going. But do you blame the manufacturers of Tylenol if someone opens up a Tylenol bottle and takes a pill that's not really Tylenol, if the seal was broken on the bottle? That would be ... You would be suspicious that it wasn't really Tylenol if the seal was broken when you bought it at the store. You probably wouldn't even purchase it.
So in the same way, I would be suspicious of anybody who's using the word Vampire Facial in the United States because by definition, if they're not on our ... I would be suspicious of them if they're not on our list.
If someone's using that name and they're not on our provider list, they are stealing. Now there are people who are trying to say that it's not really a thing and that I just want to use it, and there's no reason you have rights to it. Well, yeah, there is. We proved it to the US Patent and Trademark Office and the people who are challenging it are all people who stand to benefit financially if it goes generic. But the reason I have fought and spent way more than a house costs here in this state to defend it, is that if it goes generic, there will more of this sort of thing happening and it's to everyone's benefit if this means actually doing things in an ethical way.
Now. If you want to know more about that, there's stuff here you can go to, you can see the people that are infringers. You can see who I am, who the Cellular Medicine Association is, and like anything, you're going to find good and bad out there, but we are fighting for the safety of the use of something that can be faked off. Like you can't go out and pretend that you're a gynecologist and do a hysterectomy. That's not going to happen. But you can buy lab equipment on Amazon and pretend like you're doing ... and you can buy a microneedling device on Amazon and pretend like you're doing a Vampire Facial, and both devices could be substandard and you could be hurting people all day long.
I'll just show you. Here's Amazon, and we'll go to ... We'll put in microneedling. There you go. All sorts of microneedling devices. So you could buy one of these devices and if you're using it on yourself over and over again, okay. You don't really know how we're doing it, so it's going to be less than how we do it and the way we teach it, but you have a way to look like you know what you're doing. And all of these would be at risk for transmitting disease mostly likely ... I haven't examined them all, but I know they're not FDA approved for using it on multiple people.
So yeah, if you want to buy this and do it to yourself, go for it. It's not going to be as ... It would actually be dangerous, extremely dangerous, and criminal if you took this and you started using it on multiple people, okay? So that's where ... You could actually buy that and you can go buy ... Watch this. You can buy ... Let's see ... blood ... So here you go. There it is on Amazon. You can buy a hundred tubes for $57, so six pennies apiece. Believe me, these FDA kits are way, way, way more expensive than that. So you could go get these kits, you could go get the microneedling device, and you can pretend like you're doing great medicine and you could be hurting people, making them sick, all day long.
So for example, you couldn't fake off people and pretend like you're doing hysterectomies or mastectomies or brain surgery. But you can fake off people and make it look like you know what you're doing when you're doing this and you'll be hurting people all day long.
And how to know that someone is actually trained and not using these substandard kits, you go to our official website for the Vampire Facial, the Vampire Facelift. You click on a provider, and you know that they've been trained to know what's the FDA approved kits, how should they be used, and then they take their previous knowledge from being a physician or a nurse practitioner or physician's assistant, used to dealing with blood in critical situations, and then they apply that to a much, much simpler process and they do it safely all day long every day, just like they handle blood all day long every day in the ER or the operating suite. Think about it. You're cutting people open. Blood's all over the place, and then the next person rolls into the room and nobody gets cross-contaminated. So a little procedure with a little one tube of blood and microneedling is a very easy thing to do safely from someone who's trained adequately. It's a good way to hurt people if you don't know what you're doing.
So again, our people have been trained, we have teachers that are officially our teachers, we have 70 of them worldwide now.
Not in every country, but in multiple countries, that are trained. If you go to our Cellular Medicine Association, you'll find a link to our teachers and to our classes. We have some of the best teachers out there, faculty in multiple medical schools, who know what they're doing and they're doing this and teaching it the right way. Plastic surgeons, dermatologists, gynecologists, doing this the right way. So this is where you go and ... amazing, amazing people.
So it makes me angry when someone does this. Obviously I don't blame the victim because they were duped by someone, but our name is clean when you go to our list of people who've been properly trained. If you don't and you see someone else using our name, you're doing exactly the same thing as taking medicine from a bottle that the seal was broken on because you don't know what's in the bottle, and you may get something wonderful, but you also may get poison.
So I hope that helps, and you guys feel free to contact me. The press can reach me or doctors can reach me at the Cellular Medicine Association. Just go there and then click on the contact button and you can reach me, and that's also my email address. So I hope that helps clear this up. It's horrible that someone has possibly been hurt and I hope that helps you know how to find someone who knows how to do something that's very, very safe that also has great benefit.
Important Notice
Important Notice from the Cellular Medicine Association--the recent incident in New Mexico took place at a center illegally using our name (Vampire Facial®). Qualified medical professionals handle blood all day long without serious problems and this procedure is even safer since it's done with the patient's own blood. But done improperly--people can be killed by cross-contamination. The providers in this article were imposters.
This is the official website to find those who have been certified to do the procedure by the Cellular Medicine Association and where you can read the research--click to see our directory<-- Providers found there agreed to use devices approved by the FDA to both prepare the blood and to do the micro-needling. Anyone advertising the Vampire Facial® who is not listed there is stealing intellectual property and cannot be trusted. See PubMed & our website for more research
The Vampire Facial® name is owned by Charles Runels (see the website for the US Patent & Trademark office), although the name is currently under attack by those who would want free use of the name to sell devices and procedures without regard for our standards.
Someone using the name —as described in this article (click)—to trick people is exactly like someone making a fake Tylenol bottle and putting poison in it. Please—buyer beware! Only providers listed on our official website should be trusted to do the procedure.
Woman dies in the office of a massage therapist advertising the Vampire Facelift® (if you read the article, you'll see the person actually died from a buttocks injection of something other than blood (probably something from the hardware store--NOT from a Vampire Facelift®). This woman would have never been accepted into our provider group and was using our name illegally.
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: '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...
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.
Speaker 1: Okay. I'm here with [Michelle 00:00:03] and we are preparing for a Vampire Facelift. How are you feeling?
Michelle: Numb.
Speaker 1: Yeah. We already put some numbing cream on here face. We'll let that sit for about a half hour. In the meantime we're going to draw the blood and spin it in the centrifuge. Here we go. You're going to feel a little poke. And today we're going to be doing the face and the neck so we're going to be drawing two tubes of blood.
Speaker 1: All right. We just finished drawing two tubes of blood. How did that feel?
Michelle: It was fine.
Speaker 1: It was fine? All right. We will get ready to put them in the centrifuge and spin them down.
Speaker 1: Here are our two tubes of blood before we spin them in the FDA approved region tubes for this procedure as you can see. We have the red blood cells on top and on the bottom is a little gel separator. When the procedure ... When we finish spinning it you're going to see the gel separator move to the middle and we'll have some platelet rich plasma on top and the red blood cells on the bottom I'm putting them in the centrifuge now. And in nine minutes we'll see what happens.
Speaker 1: And here we have it after nine minutes of spinning in the centrifuge. You can see now that the packed red blood cells are being separated with the gel separator and then we have that clear gold platelet rich plasma. Now that is what we're going to be micro needling into Rochelle's face and neck and, and that is going to activate her own stem cells and growth factors to come to that area and help form new tissue, help with fine lines, wrinkles, texture, tone and tighten.
Speaker 1: Okay, we're applying the PRP, Platelet Rich Plasma, to the area of the face and neck we're going to be treating today. All right. And this is the MD pen we're using. And you can either speed it up, slow it down. At the fastest it'll puncture the skin about 220 times a second so we're creating all those micro channels for the PRP to be delivered. Now Michelle, how's that feel?
Michelle: It feels fine.
Speaker 1: It feels fine. We removed the numbing cream so she should be nice and numb. And you can see we're getting some nice little flash here. That's a good result. That's just what we want. Now Michelle, what areas did you have concern? More a little bit here?
Michelle: Yeah, the fine lines and wrinkles, especially when I'm smiling. All the crinkling and everything. I keep doing Botox but I really just want to have it re-textured.
Speaker 1: Right. I'm going to go a little more aggressive just in some of those areas that she's most concerned with. Is that okay?
Michelle: Feels fine.
Speaker 1: I'll do the face first and then I'll move onto the neck. Okay. I'm going to have you bite your lower lip. How is that? Yep. I was going to say, thumbs up, it's okay. Okay. Good. This device has a gauge on it, how deep you want the needles to go so you have to switch it for different parts of the face. Okay. Then, we did almost half her face. I like to reapply some of the PRP to those open channels so it absorbs. Now these channels will stay open for about six to eight hours after the procedure so we'll send her home too with some additional PRP to apply.
Speaker 1: All right. I'm going to do your forehead. All right, here we go. How's that? Feel okay? Good.
Michelle: I'm fine.
Speaker 1: You don't have too many wrinkles and fine lines on your forehead so I'm going to go a little lighter here. Turn. Do a little bit more.
Michelle: I'm going to sneeze.
Speaker 1: Are you going to sneeze?
Michelle: That's so funny.
Speaker 1: Usually that happens when you're doing the nose.
Michelle: I know, the nose. I feel a sneeze coming on. Sorry.
Speaker 1: All right. And we like to do two passes to really cover all the surface area. Very good. All right. We're going to do this last part of the face and then we can move onto the neck. But this is where you have a lot of concerns too so we're going to be going really aggressive here. Now you've had one of these before is that right Michelle?
Michelle: Yes.
Speaker 1: And how did you ... What did you think of the results?
Michelle: The results were fantastic. It really really softened, re-textured. My skin glowed. It felt ... it looked, [inaudible 00:06:59] so many compliments.
Speaker 1: That's great. You still pretty numb?
Michelle: Um hum (affirmative).
Speaker 1: Okay, good. All right. You're doing awesome. We're almost done. We'll put a little bit more PRP. Then I'm going to go a little bit deeper on that area of concern here. Now these are some lines where even if you do get Botox, Botox will not cover these lines here. It's not indicated for this area of the face so that's why micro needling, especially with PRP is great for that. I'm going to have you bite your lip again. Okay. And now your upper lip.
Speaker 1: Okay, this is going to be a little uncomfortable. I'll try to go fast on this one. Okay. Last area. The nose. Always a little sensitive too and lots of times people want to sneeze with this part. Okay. Okay. All right.
Michelle: Excellent.
Speaker 1: You are all done.
Michelle: Thank you.
Speaker 1: You're welcome. Again, I'm going to reapply while these channels are nice and wide open. If you see some redness, a little bit of bleeding, that redness will go down over the next 24, 48 hours. Which is nice because we're putting on these healing growth factors which makes the skin heal pretty quickly. Okay. Turn this way. How does your face feel? Little tight?
Michelle: Tight. Tight.
Speaker 1: Yeah. That's typically what we hear. Okay. We'll let her sit for five minutes. Let that all absorb and then we're going to reapply again.
Lecturer: If you take a tube of blood and you place it on the counter, it settles by weight. The heavier stuff sinks to the bottom first, and the lightest one's up at the top. All you need a centrifuge for is to make it happen faster, and when you're done, it goes red cells, white cells, platelets, in that order, and most of them are stuck right here in this thing called the buffy coat, and then this also has platelets in it, but you can see the color changes. This is my finger. I just spun the yellow top and took a picture of it. The color changes as you get closer to the top and by the time you get here it's mostly water.
Now, what is platelet-rich plasma? Remember the guy called me down at the ortho meeting because what I was calling platelet-rich plasma didn't meet his definition of what platelet-rich plasma is. I think I told him ... Did I tell him my joke about the girl and the high school kid? So my Dad told me there was this girl in his high school that only had sex twice. Once with the football team and once with the basketball team. And so, my point is that you got to, that words can mean whatever you decide they mean and people are going to use the word platelet-rich plasma to mean two different things, and I want ... They're not trying to trick you. It's a true statement, just like the girl just had sex two times. That was true. So they're not trying to trick you. They just have a different meaning for their words, and I want you to understand what those meanings are so that you can make a smart choice.
Okay, so you ready? So, if you take this, let's assume they don't, this person probably has hematocrit of about 40 percent, 45 percent. How do I know that?
Male student: Just estimate by ...
Lecturer: Yeah, exactly. You can look at it.
Male student: ... [inaudible 00:01:41].
Lecturer: Exactly. So if the crit was 50 percent, it would be half plasma and half red cells, right? So let's just to make the math easy, let's assume we're dealing with a man with a crit of 50 percent, and without using a microscope, I'm going to tell you how to know how many platelets you got. So, let me set this down for a second. So, if this were, if I just took a tube of the man that had a crit of 50 and I spun his blood in a centrifuge, I would have ... and this is 10 milliliters, I would have 5 milliliters give or take of red blood cells and I would have five milliliters of plasma with the platelets mostly living right there. You guys still with me?
Some of the platelets would be in this upper layer of red cells. The younger platelets have a weight that's very similar to red cells so they would be right here, but that's a small number. Most of them would be right here with some of them through here. So if I took this and I put that into a syringe, I would have platelet-rich plasma if my definition of rich means compared to whole blood. Right? And what would be the concentration of platelets in this compared to whole blood? Two time, three times, four times. Which one?
Male student: Two times.
Lecturer: Two times, right? Because you took the platelets that were in ten and you put it in five, so you doubled the concentration of platelets, and you didn't need a microscope. So, the gel kits are engineered to do that. When you're through spinning them ... oops, went backwards ... We should probably talk a little bit about what's in the platelets. So these are seven or so of the over 20 growth factors that we know are there. The way I describe this to the patients, and I'll say "You're making what was in that scab ... " because they always remember scraping their knee as a child, I said "You're making that yellow goo that was in the scab, and that's what prompted your body to grow the skin back." When I go to Antigua next week and teach this class, they're going to have me on the news. I always use that analogy when I talk to lay people about what it is I'm doing.
But we didn't invent a drug, we're just taking what the body normally does every time you are cut, scraped or had surgery. This is nothing hokey. If this wasn't there you couldn't heal when you scraped your knee as a kid on your bicycle. All were doing is getting those same platelets that started the thrombin cascade and we're putting it in a syringe. And we don't even care about the platelets. We care what's in the platelets. So when the platelets are exposed to collagen or calcium or thrombin, they break open and they release all these growth factors. And people say "Well, how does it stay in place?" It stays in place because it gels, and that's why you had that yellow stuff, and becomes platelet-rich fibrin matrix. Everybody say that. Platelet-rich fibrin matrix. Because when, I'll see our doctors on the news and they'll get tongue-tied and say "Rich platelet plasma" or all sorts of crazy combinations. It's platelet-rich plasma and platelet-rich fibrin matrix.
Now the Selphyl people have a great kit. It comes with calcium. They finally lowered their price a little bit. It used to, they tried to sell it for 400 bucks for those three drops of calcium, but now what they're doing, they're using a little bit of a game on our doctors, and they'll say "Well, we're the only ones that are selling platelet-rich fibrin matrix." And all they're doing is they're selling you one kit that makes the PRP and another little tube that has calcium in it. Well, heck, all of us are making platelet-rich fibrin matrix every time we inject it or add calcium to it. Okay? So don't fall for that.
All of us are making platelet-rich fibrin matrix. When you take the platelet-rich plasma and you inject it, it turns to this matrix when it's exposed to the collagen in your body. Yes, sir.
Male student: The calcium, what's the ...
Lecturer: Okay, yeah. So I haven't introduced that yet. So calcium chloride is ... I usually use 10 percent, this is in the research a lot, and again, a lot of this came from our orthopedic friends trying to think how can you ... Let's just stop and think. Why do we even need to do this? Why can't you just take whole blood and shoot it in the face? It's got platelets in it?
Female student: [inaudible 00:06:18].
Lecturer: Well, that's basically, I mean ... It's got platelets, though. Right?
Male student: Well, you're not going to get the matrix ... It's going to be diluted.
Lecturer: It'll be diluted, but you still have platelets.
Male student: So you're not going ... It's going to be too diluted to get the effect for the small area that you're working.
Lecturer: Maybe. Maybe. It's a good point and that's what our orthopedist friends would tell us, is that you don't have a high enough concentration. So the game they were playing was, they have a little, tiny space like a knee, and they need a lot of growth factors to heal something that doesn't have good flow, like collagen in a knee, so that's where the technology came from and the reason the plastic surgeons and the derms and gynecologists have to think about is you've got a lot of blood flow in a vagina and a face. I've sutured up hundreds of faces like you guys have. You hardly ever see it get infected. They can go through a windshield, get drug on the street and get urinated on and cut with a beer bottle and you wash it with a little saline, sew it up, they're fine. Not so with a knee.
And so, the game they've had to play, and same thing with the dentists at Wound Care Center in the hospital over here with the hyperbaric chamber, and the oral surgeon would send people over that had been radiated for throat cancer. Now they have to do surgery on radiated tissue, so we'd do hyperbaric medicine, then they would do their surgery and do PRP afterwards to try to make it heal better. So, what the technology, what the research shows out of that is that if you activate those platelets before you inject them, you get a more complete activation than if you depend on the collagen itself to activate the platelets. And one guy, when I lectured in Serbia, there was a guy there who had just published a paper he had worked on for 20 years. I was definitely not the smartest man in that room, and he was big on that. He said if you don't activate, the tissue itself is only going to activate about 65 percent of your platelets.
And so the orthopods have been activating with calcium and thrombin and they've been looking for what's the sweet spot for concentration, and what they have found is for a knee, the best healing takes place at about five times the concentration of whole blood, for a knee. But we don't know that that's the case for an easy to heal tissue like a vagina or the face, and what I can tell you as a clinician is that for three years, I spun gel kits. I used Eclipse, I used Regen, I used Selphyl during those three years, and a gel kit, all it does is it starts with a little goo at the bottom. You got one in your kit, C?
Male student: Yeah.
Lecturer: So want to show them one that hasn't been used. Just hold it up where they can see what it looks like. Can you pull it out of that package? And you'll see it looks like a little goo at the bottom, and what happens is that goo is stuck here and you add blood. Then the good pops up like a cork to the top of the blood. Yeah, hold it where they can see the goo at the bottom. Yeah, you see that white stuff at the bottom. Yeah, Vanna White, there you go. So, that goo pops to the top and then while it's spinning in the centrifuge, it winds up stopping somewhere in the middle so that ideally you've got nothing but red cells there and platelet-rich plasma right there. Compared to whole blood it's just this with the goo stuck between the red cells and the plasma.
So it winds up looking like this. We'll come back to all this. Like that. So platelets here, red cells there, goo right there and your buffy coat ideally should be there. If you try a different speed or a different length of time you're spinning, the goo's going to be at a different place. If you use a centrifuge with a different diameter, you're going to get a different g-force, so their intellectual property is that they know that, the people who sell these kits, that this goo put in a centrifuge with this diameter and circumference, spun at this many RPMs for this many minutes is going to put your plasma right there.
And it sterilized in such a fashion, again, nobody gives me kickbacks on any kit. Nobody. I don't get a penny. I don't get something put into my son's bank account. I don't get a blowjob. I don't get nothing. Okay? And so, that's why you see kits from eight different manufacturers back there, right? But what I'm telling you is there are people out there who don't use these kits. That's why I'm prefacing this remark. You can get a yellow top for seven dollars. You don't even have to pay for it. You can probably have Lab Corps bringing you yellow tops to your office. You all need something? You guys okay? Do you need something? I'm just making sure you're good because we got fed and breakfast and juice and you guys just came in off of a plane, so I want to make sure you're comfortable. Do you all need some juice or food or something? Because we got beignets. I hate being on airplanes. I freaking hate it. And so you're probably feeling beat up and dried up right now. You got some Perrier or something? Give them some Perrier.
So, anyway. So that's a long way of saying that don't do that because that is second rate medicine and when someone asks you is this a FDA approved procedure, what is your answer going to be? Is this o-shot FDA approved? How do you answer that?
Class: No.
Lecturer: No. Why? Can you elaborate?
Male student: Because one, it's not a drug.
Lecturer: He's right. Blood's not a drug, and so the analogy I give people is I'll say "You know, if I sell a needle and thread to a doctor ... " I'm getting back to the kits. "If I sell a needle and thread to a doctor, I can't go get a needle and thread that's made to suture up clothes and sell that to a doctor to suture up people." So, I have to prove to the FDA ... it should be called Food Drug and Device ... so the FDA has to approve a device to be used in the human body, but then once that suture material's in a doctor's hands, it's approved, now it's doctor's business. FDA's got nothing to do with how you sew up a wound. Nothing.
So in that same manner, you're using ... and you need that analogy to explain to patients ... you should be using a device that's FDA approved to prepare blood, not to examine in the laboratory but to go back into a human body, and that's a different game than preparing it to look at under a microscope. It's a different level of approval. So if the patient says that, you say "I have a device that's FDA approved to prepare plasma to go back into the human body, and I know the concentration of platelets that I have in there, but the procedure is not needful of approval because it's your blood." That's the way you explain that.
Okay, so back to this thing. So, you do this with a gel kit, you got two times concentration of whole blood, and I can tell you I've literally treated hundreds of people with two times concentration of whole blood with a very, very high success rate on the o-shot, the face, and the priapus shot. The two times concentration. In my opinion, I don't think you need more than that to do those procedures like you do with the knee, okay? On the other hand, I don't think you're hurting anything going to five times concentration, and it could be that our research eventually shows that you get a higher percentage of ... Not all my procedures work.
Maybe you get a higher percentage of success rate when you go to five times, then you do a two, just like you do with the bone. We just don't know that yet. But my suspicion is you'd get a pretty high success rate with these procedures if you used whole blood. I'm not going to do that, but my suspicion is that you might because there may be enough platelets in just whole blood to make it work for a face or an o-shot. I don't know.
But activation, whether it's by calcium chloride or by the body's own collagen, makes PRP turn into platelet-rich fibrin matrix, and that's why it stays in your penis or around the urethra or in your face because of that matrix gel holds it there. Now, here's what I've decided ss a clinician, I'm open to be taught. I'm going to send you home with more questions than answers. It's just like when you get a new drug, suddenly there's hundreds of research papers come about how to use it. Part of the danger of me teaching this is I start to believe everything I'm saying. I want you guys to go research it and figure out a better way, okay? But here's the way I'm thinking about it.
If I'm treating something like a face or the scalp, I want that PRP to spread, and if I'm treating the breast I want it to spread, and if I get a little bit less activation and it still works, I don't really care. But if I'm treating around the urethra where I want it to stay in a space that's only a few millimeters in diameter or in a penis where I want it to kind of stay in a, you know, relative to my whole scalp, it's a lot more area than here, than my penis, so I want it to spread. So what I'm doing is I'm using calcium to activate when I do the o-shot and the p-shot and when I do loss of sensation for the breast. Everything else I'm not activating it.
And what I found is a lot of our people that have told me their o-shots are not working, they've not been activating it. So I think you need the complete activation and I think it's helping it stay in place. You should be activating it when you do an o-shot. Activating it and adding something to that syringe before you inject it, so you're getting a more complete release of all of your platelets, dumping those growth factors. Is that making sense? If not calcium chloride it can be calcium gluconate, it can be thrombin. Some of the kits come with thrombin, some with calcium chloride, and Cell-Fill includes the calcium chloride, but you pay extra when you can buy a vial of calcium chloride and treat a hundred people for a ten dollar vial. Okay?
Now, what's a double centrifuge kit? What a double centrifuge kit does is it takes this and you spin it and you wind up with your red blood cells. This is Harvest, Insight, Magellan, True PRP, that's the double centrifuge. So what they do is they get, you get red blood cells here. You got plasma up here. I'm just going to call it plasma for now. And then they do a second centrifuge that pulls off the richest part here, so then you have ... If you had 60, you would get 30 of red blood cells, 30 of this total, and then you could pull off ten of this richest part and 20 of this, so this would have fewer platelets, this top two-thirds. This lower one-third would have most of the platelets, and so in this case you would call this platelet-poor plasma and this richest part would be called platelet-rich plasma.
And now this is rich compared to plasma. You see the two different definitions now?
Class: Yeah.
Lecturer: So this is rich compared to your plasma. The other, when you take all of this, this is still platelet-rich compared to the whole thing. Two different definitions using the same name. Now, what you can do, you'll see Z has a kit that spins 22-CCs and if you want you can spin that 22-CCs, have a gel kit, and then if this is your gel, you can pipette off this top part and use that part and you'd still have rich compared to ... So that's how you can alter your gel kit. So that's the two, that's kind of the idea behind that.
