JCPM2021.09.01EDResearch.PenileRehabilitation.AutologousVsHomologousVsMinimallyManipulated.Peyronies.PE

Topics Discussed Include the Following...

*How to find answers on the membership sites
*The Priapus Shot® procedure for Erectile Dysfunction. Research
*How to Do Unnecessary Things, Hurt Your Patient More, and Make the Priapus Shot® less effective (straight from the research)
*Why the PRP Research Moves Slowly
*Injections to Help Premature Ejaculation
*Priapus Shot® for Penile Rehabilitation
*Autologous, Homologous, Minimally Manipulated
*The Priapus Shot® procedure for Peyronie’s Disease

Video/Recording of CMA Journal Club, Pearl Exchange, & Marketing Tips

Transcript, Relevant Research, & Relevant Links

Transcript

Thank you, guys, for being here. I had several questions this week about the Priapus Shot® and the research supporting what we do. Of course, it's a growing body of research, but there've been a number of papers that came out in the past six months, and I wanted to tie those things together, specifically, (1)

talk about some of the research about applying PRP, using our protocols for erectile dysfunction. (2) Number two, for rehabilitation of the penis post prostate surgery. And (3) number three for Peyronies's disease. Some of the ideas, then I'll take questions.

How to Find Answers to Questions on the Membership Sites

Before I get to that, I also had several questions concerning the O-Shot® procedure, and these questions actually live on the website in a pretty robust, thorough way and much better than I could do answering the phone. So since I wound up referring people to this page, I thought it might be useful to just show you guys how some of the resources that are available to you for being a part of our group.

We've been doing this a decade now and thankfully the combination of the many minds, we're now over 4,000 members; we passed that mark since COVID slowed down; now there are over 4,000 members. The collective of both asking questions, doing research, getting together every week without much exception and talking about, (I think, once I skipped for a Bob Dylan concert and once a hurricane shut me down, but we just didn't have electricity); other than that, we haven't missed many.

Next Workshops with Live Models<---

And those webinars, some of the better ones, or many of the better ones are recorded and transcribed with the transcription searchable. Maybe the people in the group don't know this is available, but one of the questions that happened today I wanted to point out because it's a common question. What happens if the O-Shot doesn't work? What do you do if your person doesn't get better? I wanted to show you where that answer lives and how to head off disappointment by referring something, showing your people this, and then we'll get back to the research.

But I'm just showing you functionality. When you sign into the O-Shot website, the membership side, you're going to be looking at this dashboard. Of course, many of you have already been in the group for a while, so you have a good understanding of how to do the procedure and come up with your own ideas and innovations, depending on what the problem is.

Navigation to Answers to Questions

That's the thing. I want to make it clear. I'm the first person to point out these are not magic shots. These are not magic shots, inaudible 00:02:58. If someone is having dyspareunia inaudible 00:03:02, well, the pathology lives right there in the local tissue and we have something that makes tissue healthier. If they have anorgasmia, that could be any part of the orgasm system, from psychological blockage due to some sort abuse as a child or modal abnormalities, lots of things, other than local tissue.

Depending on the problem makes a big difference about the percentage of the results and the likelihood of a particular patient might get results based on where the etiologies of their person's problem might lie, since their usual, almost always multifactorial was something as complicated as sex.

Anyway, back to what to do, because there is no procedure that's perfect, and so what do you do when the O-Shot doesn't work? If you go and you log onto the dashboard, you'll see this. If you go to this webinar page, you'll see that I posted here, first of all, the difference between an O-Shot® and a G-Shot®. You should know that, because that question comes up a lot, and they are not the same, and we are not aiming for the G spot when we do the O-Shot. We're aiming for, and I explained the difference and why, what thinking is in that video.

Then if you scroll down here, there's this question, what do you do when your first person with an O-Shot doesn't get well? Everything from, first of all, if it's only been two days, they haven't had time, versus the different problems they may have presented with.

And again, I don't claim to be the know-all end-all be-all, I'm far from it. I'm sure many of the things that we're thinking and saying will be proven to be wrong, or hopefully on the path to what's better, but with our best understanding of today, from the research and from talking to 4,000-plus doctors and teaching this almost every month, at least for a decade, my best understanding from curating the ideas of the group for the past decade lives on this website.

Now, if you have a specific problem, you can also go here and search. So if I just put in say, dyspareunia and search, it's going to come up and bring up the transcriptions where we talked about dyspareunia.

Not every video got transcribed, and not every webinar made it to the website, but we do have over 400 videos, and so you'll find lots of conversations.

Then if you just want to see the last one that was posted, say, you get an email and says, "Okay, I just put up a webinar," which will happen after this one, just put up our journal club from last week. You just go to recent posts and you can find the most recent one, so you can see the last one, where we had one of our premier teachers and providers on the group talking about how she treats women who have genital mutilation, and gave a really moving story and some amazing clinical pearls. And I've put the research that backs up what we talked about below it.

Later, when I talk about the research regarding the Priapus Shot®, that's where it will live and I'll have links to all of it. And so, I've shown you where to find the video about what to do, if your first or any of your O-Shots don't work.

Also, I would recommend that you send your people to this recording, which I put here to help answer some of the questions that happen before they get asked. So if you scroll down here, this is just a podcast. And I recommend you listen to this and do your own version of this, either written or recorded, as a podcast or a video, where you put your experience in here. But this is me telling people what reasonably to expect, depending on the procedure and depending on the problem that's being treated.

Hopefully, you found that helpful. Of course, we're always on standby to help you. We have a staff of 10 people, actually, we're down to nine people, depending on...If you want to count our virtual assistants, we're more than that, but people flesh and blood living close enough to report to an office, we have nine full-time people, and others on retainer.

So we have a support staff that's made to help you guys if something comes up that's unusual. Like today, I've got a question that was about an unusual problem. I honestly didn't know the answer, but I went to the research and ask a few other people in the group and we came up with an answer.

Okay. That's our promise to you about how to find the answers, and that same idea would go for all the procedures, you just log in and you can use the search bar to find where we talked about it, if you want to see what we talked about recently, and we do usually cover research that's been out within the past month or two.

And like this one, we talked about research and treating keloid, that's very recent. And we usually have one of our teachers on the call, this one we had inaudible 00:08:42 talking about how he treats scarring and the surgeries he does in combination with how PRPs are used for scarring.

The Priapus Shot® procedure for Erectile Dysfunction. Research

Okay. That's enough about how to find the answers to questions. Let's go into what I think some of the more premier studies are regarding our Priapus Shot procedure since that's... I think, we'll start with this one study, which came out... Oh, it made the cover this year of the Journal of Sexual Medicine. So many of you guys saw it in an email because I was so proud of it. It was like having a picture of your idea of a baby. So you have three sons, and so it's not as fun as having a picture of your baby child, but it's fun to have a picture on the cover of a high-impact magazine that shows a graph, a picture of your brainchild.

This is that study.

How to Do Unnecessary Things, Hurt Your Patient More, and Make the Priapus Shot® less effective (straight from the research)

We briefly mentioned it in a previous webinar, but I wanted to dive a little deeper into it about their study design and tell you why, although I'm grateful for the study because they did show benefit, and this double-one study where this came out of Greece and very well done study, where they used saline as the placebo, which makes me a little nervous, because saline being a physical therapy, if you inject it, it's not exactly a placebo, but they still showed benefit. But I wanted to show you the method and why I think maybe it's wasn't as good, or it's not what I would have done, and why.

They were randomized. They used inaudible 00:10:45, which is a double-spin centrifuge, as you guys know, that part of the criticism of all of the PRP studies, especially the man analyses, is that there's still no real consensus about what exactly PRP is. It's a lot of apples to oranges. And in their conclusion, they even stretch it to say, "Well, we can't really extrapolate this to other PRP preparation systems, which is somewhat true in that a double centrifuge would be much different than say a gel kit, but maybe not that much difference between double centrifuges.

Anyway, that's right, you can't extrapolate to every PRP prep kit, but they did show a benefit.

Okay. With this kit, I can tell you, they've got about five times the concentration of whole blood, doing what they did.

Now, this is the part I wanted you to see. After repairing the injection, they're placed in the supine position, a tourniquet was clipped around the base of the penis. Now some of the people in our group do this, most do not, and I'll show you why I don't. I'm going to show you a picture. You guys, of course, don't need to see a picture because you can visualize it. But if you look at a picture of the penis, if I put a tourniquet right here, we're missing out on treating a good portion of the penis.

Now what really this tells me is that, and I'm just going to speak plainly. I've already prefaced it by saying I may be completely wrong or shown to be wrong down the road, but we've been getting great results without tourniquets. It's not something that I didn't consider the first time I did this, which was on my own penis, now 11 years ago. I thought, well, maybe I put a tourniquet.

The reason I didn't is to think about it. When we do the facelift, we don't put a tourniquet around their neck. And actually, when you do it, you can see that it stays there. And the reason it stays there, is the PRP, which you guys know is activated and then the platelet-rich fiber matrix is formed from this gelatinous matrix that's set up, that's intended.

It's the thrombin cascade. You don't really have to put a tourniquet to keep it from going back into the circulation, but it could be a worry because technically it's an intravascular space.

Now, the other thing that gets batted around sometimes, which I'll just tell you it's going to happen because first, they laugh, and then they take it, and then they bar you from it. That's what happened with a heart catheterization. The radiologist first did it.

And a radiologist who attended my class, an interventional radiologist, just told me once, he said, "Charles, watch. What happened with us was we did it and then the cardiologist took it over."

He says, "Eventually, this is going to be shown and widely done, but then the urologist may want to be the only ones who do it."

That could happen.

If you think about it, and I've already had a couple of urologists suggest, this should only be done under ultrasound.

Now here's my argument against that. What is smaller: Putting a needle into the vein of someone or putting a needle into the corpus cavernosum?

For most guys, I would say that the corpus cavernosum is significantly larger than the veins on their arm and I don't need an ultrasound to do it.

Now, there does need to be some understanding of the anatomy, but if a man can do his on Trimix injection and get a needle into the corpus cavernosum, I do not need an ultrasound to do a Priapus Shot, but I've had some urologists look at me with a straight face and tell me that's the way it should be done. I think that's just a prelude to saying that only urologists should be doing it.

Okay.

The other thing that I think about, back to the tourniquet thing, I think what happens is that those who have injected the face and have seen how PRP behaves, would know that the tourniquet is probably not necessary. Again, these guys are brilliant.

They did the study.

I love them for doing it.

It strengthens our position, but when you read the study, I want you to know why I think maybe they're changing of our method was based upon their having not injected faces for a decade.

Okay.

Then the other thing, and this really makes me cringe more than if someone were scraping their nails across the proverbial blackboard. A total of five cc's was infused in each other corpus cavernosum, get a load of this, by slowly retracting the needle for better distribution of PRP into the rectal tissue over a two-minute period to minimize platelet cell injury.

Are you're getting the picture?

It looks to me like they put a needle, and threaded it through the corpus cavernosum, and then slow ...

My penis is retracting right now.

It's an innie instead of outie.

And then they slowly over two minutes, retrograde injected PRP into the penis.

I mean, okay. So, all right, whatever. I don't know. I think I'm going to leave it at that, but I don't think that's necessary.

These poor guys.

They should have called one of us up and then asked us about ... Or maybe come and watch one of us inject faces to know that when you inject a sponge, it's this corpus spongiosum and the corpus cavernosum is similar with all the sinusoids, you wouldn't have to take a needle, and thread it, and slowly move it out of the sponge to fill it. Just inject it and let it spread well.

Well and what about this minimizing platelet cell injury?

I want the platelets to be injured when I inject them. Actually, I'm going to activate them and make them release those growth factors and put them into the penis very quickly within a minute or two, so while they're still active. This really made me cringe and I didn't want anybody thinking that's the way it should be done.

Again, great respect for these guys, but holy smoke, I'm glad I wasn't one of their patients.

Okay, was performed under sterile conditions without anesthesia. Thank you very much.

Following administration, additional compression of the penis with a dressing placed around the penile shaft. And then, the tourniquet was removed after 20 minutes. Holy smoke…

Tourniquet two minute retrograde per side, without anesthesia, so we got four minutes per total of injecting. And then, you're going to put some sort of compression dressing with a tourniquet at the base for another 20 minutes. And then, they're instructed after the tourniquets removed after 20 freaking minutes, then they go home and take the compression bandage off four hours after the injection.

All right.

What's the idea behind that, the compression bandage? So you don't bruise. Get a clue.

We're making a bruise. We're creating an artificial hematoma.

When you do this, what happens when you get a bruise? Plasma comes out of the blood vessel, activates the thrombin cascade, and you get a bruise or a hematoma. That's all we're doing. The only difference is that we're taking the blood out and because we're fractionating it, instead of just the amount of blood ... Let's say you have a bruise or a hematoma that's a centimeter. Okay. That'd be a cubic milliliter, a milliliter. We're injecting five milliliters, so that'd be five centimeters if it were water. Now, remember, your definition of a millimeter is a cubic centimeter.

You put five cubic centimeter hematoma, but you have, because you fractionated and concentrated the PRP, you had the same amount of growth factors as if you would have had a 60-milliliter hematoma, or a 30-milliliter hematoma the way they probably did this Magellan kit, or 60 milliliters total, which of course, would be fricking amazingly painful. Still, it's a hematoma, and it's going to stay there, and you don't have to create it slowly because you want everything to be activated.

I just wanted to go through how they tortured these poor guys and realize it still worked, everything is great, but we don't have to do it that way.

You guys know we have a better way of doing it.

And I think doing it the way we do, you are actually treating all of the corpus cavernosum, both the part that's outside in the room and the part you can't see that's just as important and necessary for erectile function.

But yay for these guys, I still want to congratulate them. Great study.

I just wished they would have come and done Vampire Facelift® with us for a week or two before they designed these things and tortured these poor guys.

Okay.

But still, cover the fricking Journal of Sexual Medicine. That's huge.

All right. This one I wanted to look at, this is a review of current ... One more about erectile dysfunction and then we'll get to Peyronie's disease and penile rehabilitation. This one, they go through just reviewing, just like it says, current therapies for erectile dysfunction. They have a section for a PRP, which let's see, here we go, which they give us a good review. It's the same criticism, which we deserve. There's a need for standardization of PRP processing methods, which is part of the reason for our group. We've agreed that you should be at least one and a half times, you should activate the PRP with calcium chloride and calcium gluconate, thrombin, or something because we know without activation ...

See that's the other thing. These guys did the slow through the needle, so that means they only had 65% activation by one of the platelet experts that I talked with in Serbia when I was there. And so, they basically undid their centrifuge, if they happen to not activate them all.

There is a need for standardization, which is what we're doing.

The reason for our group, is we're trying to come up with some ideas. At least we're going to use an FDA-approved kit, so we know whatever amount of PRP we think we have, we at least have that. It may be different than someone else's kit, but we know what we did with our kit, which is something. When you look at some of the studies, they're just using yellow tops and pipetting, which is completely non-reproducible because maybe your lab tech pipettes today and everything's fine, and tomorrow they smoke two joints and had a fight with their wife, so their pipette technique is a little different.

I like something that's standardized in an FDA-approved kit, and it's sterilized in a way that you're able to say that this PRP is safe to go back into the body.

That's some standardization, and there's a need for more of it, and we do need more randomized control trials with larger patient samples.

Why the PRP Research Moves Slowly

Part of the hindrance with us, of course, is that we're grassroots. We don't have many millions of dollars, like a drug company. There is no patent on blood and the PRP companies, about all we can have them do when we do our studies, is they'll give us free kits sometimes. That's about it. It's hard to ... One of the Emcyte/PureSpin reps, Jeff Petrillo, gave us some cash for a study, but other than that, I've never gotten anything from anybody other than free tubes for the studies we've done.

So including the Magellan people who did that, who provided the kit for our lichen sclerosus, two of those studies and for the one you just saw that was done at the University of Aristotle in Greece.

Okay, so that's two very nice peer-reviewed articles. One of the Journal of Sexual Medicine, the other out a couple of years ago in Medical Sciences talking about PRP for erectile dysfunction.

Injections to Help Premature Ejaculation

This one, frankly, I haven't done for my patients, but it's coming, and some of the people in our group are doing so I didn't want you not knowing about it, and I wanted to bring it up because we now have some studies talking about it, plural. I'm giving you one of them, and this is peer-reviewed International Journal of Impotence. This is a high-impact journal.

And what they're doing is they're using HA as a way to decrease the sensitivity, and of course, the side effect is the penis gets bigger, which is for most guys, not a bad thing. So this is coming, and you can see some pictures, you can see how they're doing it.

I'm a little bit hesitant to do injections in the glans because technically... With HA, because technically you're putting HA in the intravascular space. I'm less hesitant to put it subdermally for just pure girth, and also it could have some decreased sensitivity in that case, because you're subdermal, not in the intravascular space.

And we know a long, long history of HA not causing neoplasia, and I liked Juvederm Ultra Plus because the granuloma formation is almost zilch and good safety profile.

So I don't teach this, but I wanted you to know about this study. Again, I'll have links to all this when I put it on the website and just showed you how to find it, and it'll be up by next week.

So that's for... I've actually put... I won't show it to you now, but if you go on Amazon, I put one chapter of a book I've been working on about premature ejaculation, and I honestly think the best way to treat it, it's probably not with our injection techniques, but I think adding it, injections, to other things could be very helpful.

So I think that's all I'm going to say about this. Now, the next one, though, I think is extremely, the next two, I think are very important. One about Peyronie's and the other about post-prostate surgery, and then we'll shut the place down the.

Priapus Shot® for Penile Rehabilitation

The first one is about post prostate surgery.

We've been doing this now for a decade. Finally, I love that someone's talking about it.

Reading between the lines, I like people that give us a hard time. Always be grateful for your intellectual enemies, because they make you be smart. They make you smarter. They make you have to think and work and do research and think about your position. So I'm not offended by this, but I also want to walk it through line by line because there's some...

First of all, they rightly point out the legal problems of stem cell therapies in the United States. Be careful. In my opinion, if you're in the US, you should not be saying the word stem cell in relation to your procedures, unless you're talking about how platelet rich plasma recruits themselves from the bone marrow. Unless you have an IRB-approved research protocol.

Autologous, Homologous, Minimally Manipulated

Now, because platelet-rich plasma is autologous and homologous and minimally manipulated, and those three words, if you're not sure what they mean, we have some stuff online that explains that, but briefly autologous, from the person, homologous in that it's doing the same thing where we put it, that it was intended to do had it occurred naturally. So we put it in the penis to help it regenerate neovascularization, neurogenesis, collagen production, which is what it would do if there were an injury. So we're asking it to do what it would normally do, which is homologous. And it makes sense. You shouldn't have to do, we want to, but you don't have to prove that making blood flow, if you treated a wound in the leg, would help a wound in the arm. And by the same token, because PRP is not a drug, you don't have to prove that it would help with those things in the penis if it helps in the leg.

And it's not even off-label because it's not a drug.

Now the kits were made to do PRP for a specific indication, but that's the kit.

The PRP, once it's made, it's not even FDA business. So autologous, homologous use is minimally manipulated in that we haven't done so much to it that it quits being the person's body as what happens with stem cells. So, so that's why it's safe and long, over a decade, close to two decades now of safety, many studies. The safety profile is amazing.

So let's just look at these two paragraphs. The use of PRP to improve erectile function has been reported. Now, remember, we're talking about rehabilitation following prostate cancer treatment or surgery. And of course, this would vary based on the surgery, and hopefully, we'll have more of our urologists, we have quite a number of urologists in our group who will extend these ideas.

So there have been preclinical and clinical studies in vitro, in vivo, and rat studies, it's been shown to work. So promising data with good short-term safety, and he goes through some of the studies that are out there.

Now here's the part where it gets a little bit political, but that's okay. Again, I like people who rough us up a little bit so we think harder. The evidence to support PRP in treatment is not strong especially in the setting of prostate cancer. Well, depends on how you want to define strong. Not strong enough, obviously, that every urologist is doing it. So I'll go with that. But we have now at least a dozen very good studies in high-impact journals. But he's also right that using it as part of a penile rehabilitation protocol post-prostate surgery has not been studied that much.

In other words, we don't know how much it adds to the penile rehabilitation protocol. But we know that it seems to make sense, and when it has been looked at, it seems to help. So I and others in the group, after the person has gone through whatever the urologist intended, and now they're as good as they're going to be, I've put people back through the normal penile rehabilitation protocol, which is daily Cialis, daily vacuum device, and then added in a Priapus Shot with great results. That's not a study, I know, but it makes sense. It's not waving a crow's foot and doing something that's not supported by research.

So my thinking is there's no finish line. There's just a gradual knowing and learning and a gradual, but reluctant, understandably reluctant, acceptance until insurance is paying for it and everybody's doing it.

But if I'm the guy who loves my wife, taking one of the veterans I treated, I'm close to Pensacola, so a lot of veterans live there since there's a base, who have been married for 50 something years, he had prostate surgery, he was several years out, wanted to do another honeymoon with his wife and wanted things to work. So I put him back through the protocol, the usual penile rehabilitation protocol.

He's several years out from his surgery. And within a couple of months using Cialis, he was able to have an erection again. But before the protocol, using Cialis, he was not.

Now, is that worth doing?

I think so. I think it's worth doing, and it doesn't mean that it needs to be that everybody's going to do it. But my thinking is that if there's enough research to support it, it's safe, you have a person sitting in front of you that might benefit, then I say do it.

And he's right, none of these studies were...

This is where it gets political, the medical hype and the commercialization within a limited regulatory framework have deterred high-quality research data. Here's where I'm going to call BS because commercialization doesn't limit high-quality research. Actually, you can't commercialize blood. Commercialization of a drug gives you billions of dollars of research, and add on the fricking Superbowl and gorgeous supermodels who walk in your office and give you an erection trying to get you to write a prescription for something.

So it's the opposite. We will never have that with platelet-rich plasma ever because there's no patent on it.

So this I'm going to call total BS and it should be struck out, the editors should have struck this out because commercialization doesn't limit research. Commercialization helps research. And because we cannot commercialize PRP, we can't do the kind of research we want to do.

But what he really means here is that “It aggravates me that somebody is charging the cash for this instead of doing only whatever Blue Cross Blue Shield decides is appropriate.”

And this is why this sentence is why you must, you very must always swear before whatever's holy to you that you will give every patient all of their money back if they ask you to, because the person who wrote this sentence will crucify you and call an audience to applaud if you keep somebody's money who is not happy.

There's a lot of anger in that.

It's completely wrong because remember, commercialization pays for research, and our little fees that we charge allow us to make a living, but they don't allow us to do half a billion-dollar research as Flibanserin does. So this is a BS sentence, but whatever, I'll forgive them, because it makes us smarter and it makes us want to do whatever research we can afford to do.

Now, none of these studies is designed specifically as part of a penile rehabilitation protocol, which is true, in addition to clinical application and specification of PRP needs to be optimized and standardized.

All that is absolutely true. Okay.

But the bottom line is thankfully it's being talked about, and I'm so grateful this person wrote this article because it's a high-impact journal and the discussion has been going, but now has been brought, you can see this is fairly recent. It's been brought to the forefront and hopefully, you guys, you can see this was this year it came out. So we will just keep doing this discussion and gathering data.

The Priapus Shot® procedure for Peyronie’s Disease

Okay. So now, that last one, and then we'll call it a night, talking about Peyronie's disease. This one's been out for five years now, but it's still my favorite because this guy's a wizard. I have a textbook of sexual medicine and Ronald Virag's pictures in the front of it. This is not a lightweight.

And he did, instead of using a placebo, he used a positive control. He did good ultrasound studies with visualization and showed that PRP worked better than the positive control—Xiaflex.

And he showed that PRP works better than Xiaflex for Peyronie's disease. And the side effect of course, is with PRP or the Priapus Shot, the side effect is you get a better erection, a harder erection on the erection scale. Virag usually documents an average of about an increase in seven on that scale of five to 25 versus Xiaflex where you have a 5% or one in 20 chance of developing a penile fracture.

So Priapus Shot side effect, harder erection.

Xiaflex side effect, fractured penis, limp noodle.

PRP side effect: bruising, cost a couple of grand.

Xiaflex side effect: fractured penis, costs you the price of a nice car, 50 grand.

So not saying Xiaflex goes out the window, but for my thinking, we have a good, strong case in a high-impact journal by a very prominent physician about this.

Now, a couple of things about his methods, then we'll shut it down. He injected them once a week and he injected into the plaque. My thinking, two things about that, if you look at soft tissue studies and there's a lot of them because platelet-rich plasma, as you guys know, has been used in wound care. So there's a lot of studies about PRP and looking at soft tissue. Also, now in the past 10 years in the aesthetics space, look what happens to soft tissue. So full effect is eight to 12 weeks. So to repeat it weekly, to me seems like more than what's needed. It's like fertilizing your lawn before it has a chance because this is growth.

This is not a pharmaceutical effect. It's propagating cell growth. And to do something to propagate growth before you've achieved the optimum growth from procedure number one to procedure number two, in my opinion never hurt anybody.

There's no downside, but perhaps they were treated more frequently than what's necessary.

Secondary, again, no harm done, but if you look, Dr. Virag is doing this, his disclosure is that he was doing it for the region company, Regen Lab. So again, I know the Regen people are ethical, but there's a different motivation than there would be--say with a clinical person like myself in rural Alabama, where having this treatment done every week would be beyond the convenience and budget of many of my patients.

But I'm glad he did it.

And it could be that doing it weekly maybe and made it more likely to work. I'm sure there was a lot to this. I'm just saying that interval doesn't necessarily translate clinically. And I wanted to point that out.

Second thing is that probably the person that I know this to have done more Priapus Shots® than anyone on the planet literally at seven clinics now, all of them doing seven or eight P-shots® per day: when he treats Peyronie's disease, he just does a normal Priapus Shot. In other words, it may not be necessary to inject into the plaque.

I'm not saying it didn't help, perhaps it makes it more likely, but we don't have a study that shows Peyronie's disease injecting into the plaque versus Peyronie's disease just injecting into the corpus cavernosum. It's one of those things we discovered a decade ago accidentally by just trying it in some people years before the study was done, just trying with people and getting great results.

Also, I actually spoke with Dr. Virag. We shared the podium in Venice, and when I asked him, clinically, when he treats a person outside of study, he combines it with a vacuum device because there was a study in the British Journal of Urology showing that 51% of men canceled their surgery for Peyronie's disease if they used a vacuum device twice a day for 12 weeks. So just traction, physical traction, and hyper expansion, and I think it needs to be vacuumed, not a traction device for best results, because you're going to expand the erection more than... It'll be like hyper-inflating a balloon. And then when it goes back to normal, I think there's some correction of some of the scarring and helping with the curvature more than if you just did say traction or try and mix injections.

Okay. So that's the studies I wanted to go over and I'm looking to see if there are any questions. And the penis pump, that's right, they didn't use the penis pump, Elizabeth. By the way, I saw your idea. Great. I won't bring it up today, but one of the leaders and teachers in our group, Elizabeth Owings wrote a book about clitoral anatomy. And she had an idea she sent to me today in an email. So hopefully I'll have her develop it to the place she wants to teach you guys about it.

But yeah, no penis pump in this study. And if you look at these studies, that's part of the study problem, if you go back to penile rehabilitation. The guy's giving us a hard time for not doing the thing, but to really look at the rehab protocol, you'd have a three-variable study. It would be a pump, vacuum device combined with Cialis combined with the Priapus Shot versus one of those things alone.

Yeah. I mean, you see, as we all know, doing multi-variable studies are difficult to show results in, so much so, I guess it's been six years ago now, there was an editorial New England Journal of Medicine talking about this problem and the FDA trying to encourage people to do multi-variable studies, but no one really wants to do them because they cost a lot of money and you wind up having trouble showing what you intended to show.

So I think with that, I don't see any other questions. I just wanted to go over those things. And hopefully, you found that helpful looking at the studies and I'll put links to these what I think to be critical ideas in the membership site and on the research page for you to refer patients to, along with the recording of this meeting. So thank you very much.

You guys have a great night.

Good-bye

Relevant Research

Chung. “A Review of Current and Emerging Therapeutic Options for Erectile Dysfunction.” Medical Sciences 7, no. 9 (August 29, 2019): 91. https://doi.org/10.3390/medsci7090091.
Chung, Eric. “Regenerative Technology to Restore and Preserve Erectile Function in Men Following Prostate Cancer Treatment: Evidence for Penile Rehabilitation in the Context of Prostate Cancer Survivorship.” Therapeutic Advances in Urology 13 (January 1, 2021): 17562872211026420. https://doi.org/10.1177/17562872211026421.
Littara, A., B. Palmieri, V. Rottigni, and T. Iannitti. “A Clinical Study to Assess the Effectiveness of a Hyaluronic Acid-Based Procedure for Treatment of Premature Ejaculation.International Journal of Impotence Research 25, no. 3 (2013). https://doi.org/10.1038/ijir.2013.13.
Poulios, Evangelos, Ioannis Mykoniatis, Nikolaos Pyrgidis, Filimon Zilotis, Paraskevi Kapoteli, Dimitrios Kotsiris, Dimitrios Kalyvianakis, and Dimitrios Hatzichristou. “Platelet-Rich Plasma (PRP) Improves Erectile Function: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial.” Journal of Sexual Medicine 18, no. 5 (May 1, 2021): 926–35. https://doi.org/10.1016/j.jsxm.2021.03.008.
Virag, Ronald, Hélène Sussman, Sandrine Lambion, and Valérie de Fourmestraux. “Evaluation of the Benefit of Using a Combination of Autologous Platelet Rich-Plasma and Hyaluronic Acid for the Treatment of Peyronie’s Disease.” Sexual Health Issues 1, no. 1 (2017). https://doi.org/10.15761/SHI.1000102.

Relevant Links

-->Apply for Further Online Training for O-Shot®, P-Shot®, Vampire Facelift®, Vampire Breast Lift®, Vampire Wing Lift®, or Vampire Facial®<--
-->Next Hands-on Workshops with Live Models, worldwide <--

--> IMPORTANT (ONLY) IF YOU ARE NEW TO THE CMA: Please take any relevant online tests so that we can immediately list you (and your clinic) on the directories and start supplying you with other helpful marketing and educational materials. Testing takes an hour at most (including watching the videos. If you want to expedite the testing, you can simply call the CMA headquarters (1-888-920-5311 9-5 New York time Mon-Thur; 9-12 Fri) and one of our business consultants will log you in and walk you through where to find the study materials and the tests. If you are already on the directories for the procedure(s) you provide, then you already took the tests or did hand-on training with evaluation by your instructor.

O-Shot® CBD Arousal Oil. O-Shot® providers order wholesale by logging into the O-Shot® membership site, or by calling CMA Headquarters.

Altar™--A Vampire Skin Therapy™. All CMA members can order wholesale by logging into the membership sites and going to Dashboard-->Supplies

 

 

 

 

 

 

 

 

 

 

Charles Runels, MD

 

 

 

 

 

Cellular Medicine Association
1-888-920-5311

 

JCPM 2018March14.FDA.Altar™.AllergicGranulomatous.Profit.VolumaVsJuvederm.CaCl

Topics Discussed Include the Following...

-FDA Talks about PRP & Stem Cells in the NEJM "Balancing Safety & Innovation for Cell-Based Regenerative Medicine.
-Altar™. Vampire Skin Therapy™.- Protocol for Vampire Facial™ Combination.-How it Works
-Facial Allergic Granulomatous Reaction and Systemic Hypersensitivity Associated With Microneedle Therapy for Skin Rejuvenation
-Installed Base Profit Model & How the Pharmacist Makes Off with the Booty
-Can you use Voluma® instead of Juvederm® when doing the Vampire Facelift® procedure?
-Calcium Chloride Sources and Mixing

Video/Recording of CMA Journal Club, Pearl Exchange, & Marketing Tips

Transcript
FDA--PRP & Stem Cell Guideline Summary

Charles Runels: So, if you look ... So, we're talking offshore havens, polar extremes, medicines wild west, unlicensed stem cell clinics ... When I saw this article come out, this is when I started becoming extremely careful, or ... I'd already been careful, but more careful in warning those in our group to be careful [00:00:30] about the words used. These articles, by the way, are often written, including the one we'll cover today, by people who work for the FDA, basically telling you how they think, how to play by the rules, and what's not playing by the rules. In other words, "We're coming after you if you don't play sweet."

Balancing Safety and Innovation for Cell-Based Regenerative Medicine (click)<--

So, this one is extremely important. Let's go ahead and open it up and get to it because [00:01:00] it lays down the rules, and if you want to go deeper, it tells you where to find it. So, both of these guys ... By the way, if you scroll to the bottom, you can see they are from the FDA. So, that's where they're affiliated from. So, this is great. You're getting it straight from the people who are making the rules.

I just want to point out a couple things. Most of you guys know this already and you're looking at it, but those who aren't, [00:01:30] just a few things to notice. If you look down here somewhere in here, they say that the definition of stem cells are obviously ... Depends on who you're speaking with. And they make a big point in here, but they make a big point out of the fact ... I'll just quote it. It says, "Even in the absence of serious, adverse events, the use of therapies that are of unproven efficacy is a disservice to patients in public health. [00:02:00] An increasing number of safe ..." I'm reading from somewhere in here. I don't know where it ... One of these paragraphs. It says, "An increasing number of safe and effective therapies," I'm back to quoting this, "are becoming available on the basis of the findings of well-designed clinical trials."

But then, if you pop above that, it says, "Two explanations [inaudible 00:02:20] should be safe and effective for so many different conditions, and [inaudible 00:02:28], and that they can [00:02:30] differentiate appropriately based on the environment to which they're introduced, but we now know with reasonable certainty," I'm still quoting this, "from the scientific literature that this is not always the case." And if you search through the New England Journal alone, you'll find a few scattered articles where they talk about the wrong tissue growing in the wrong place.

FDA Guidelines About HCT/Ps<--

So, this article is part warning, but thankfully, mostly explanatory about how [00:03:00] to know when you're safe and how to play by the rules. And I'll just go ahead and say, the punchline is down here in the fine print. In this, they give you where the rule books are: four guidance documents, and here's where to find them. Right there. Okay?

So, by the way, this is a free ... You don't even have to be a subscriber to read this article in the New England journal. They make it available to you.

So, two other quick points, and then we'll come off of this. Definitions ... [00:03:30] So, pull this up. Right here. Okay? And all these section numbers and everything ... I'm gonna try to simplify this. I don't claim to be an FDA expert, but I want to make sure I know the rules well enough to play and keep them from knocking on my door. So, section 351, there's two basic things that make ... Where the FDA gets to govern how we talk [00:04:00] about human tissue. Right? They don't have any rights obviously on your hair, your urine. That belongs to you. So, when does it become FDA business?

It becomes business, and this is the paragraph that outlines it for you, when it becomes "a biological product," which is sort of nebulous to me. That's 351. And 361 is "when there may be risk of infectious disease." And so, [00:04:30] then they define this HCTP right here. So, regulatory human cells, tissues, cellular tissue-based products, that's the acronym for that.

So, the fun thing is that they make a big point of telling you in this chart what doesn't even ... In other words, we don't look at it. It's not even on our radar. Human milk is not even ... Because it's not even considered HCTP, [00:05:00] so those two regulations, 351, 361, that have to do with biological products and transmission of infectious disease do not apply to anything on this list.

And the last on the list, whole blood or blood components including platelet-rich plasma. So, if you're looking for something in writing that lets you know the FDA's not going to be knocking on your door when you're using platelet-rich plasma, there it is. The other thing that sometimes comes up, "Well, do I need the [inaudible 00:05:30] [00:05:30] waiver or something that says that I have a laboratory clearance to be able to do this?" You do not because you're not analyzing it, so you do not need that. So, here's your in-writing thing. This comes up sometimes from IRBs who are replying for research. Sometimes the institution review boards are still not sure exactly what has to be done to be able to do this. There it is in writing.

Now, when you get up to this area, this gets divided based [00:06:00] on what you're doing. If it's a biological product, then it has to be approved or regulated, I should say, to make sure it's been manufactured in an acceptable way, but it does not have to be approved like a drug. If you start manipulating it, then it becomes a drug, and they can rough you up about it.

So, it's a really nice article. Most of you guys ... That's all you need [00:06:30] to know or all you want to know, but if you start to do any research or your attorney, or whoever's doing your keeping you out of trouble person in your office, needs to read the definitive article, that's it. And I'm happy to put ... I'll just go ahead ... I'll put a link in the replay of this on the page where this video will sit inside our website. And I think that's all I want to say about it.

Next thing I wanted to talk about that might be helpful [00:07:00] has to do with a really deep dive into what it means to be having stall-based profit model, and how that helps your practice, and how the pharmacies are sort of ... They're walking away with the booty because they've got an interesting set-up which I'll dive into in a minute and tell you better how you can take advantage of it. [00:07:30] But let's ... In a way that helps your patients, and helps you keep the lights turned on, and puts your kids through college ... But let's answer a question quickly, and we'll come back to that.

So, not so many questions this week, which is good because it gives us time to dive deeper into how the profit gets made, and our most profitable members of our group, and what I think is going on in some of the groups that struggle. And I've learned this from being [00:08:00] beaten up, you really understand, as you guys know if you get hit by a left hook, you start to watch for the left hook, so I don't ... Anyway, we'll get to that. Let's answer a question.

Can You Use Voluma® Instead of Juvederm Ultra Plus® When Doing the Vampire Facelift® Procedure?

This is a good one. So, "Have you used Voluma ..." Let's open this up where we can see it better. Here we go. "Have you used Voluma instead of Juvederm Ultra Plus during the Vampire Face Lift, particularly in the cheek region of the procedure? I thought I saw this question, but I can't seem to find it. [00:08:30]

Further, any suggestions for a micro-needling device for the Vampire Facial?" Two very good questions.

Recommended device for the Vampire Facial® procedure

First of all, the device question is simple and easy because as of literally a week or two ago, there's only one device that has become FDA-approved for micro-needling in the way that we're using it for scarring, and not tattoo removal. Now, that doesn't mean you can't have another one out there, but if you want the only, at this present moment, FDA- [00:09:00] approved device, it's the SkinPen. And they don't pay me to say that. No device company gives me one penny. I keep it that way even though lots of pennies are offered to me.

But as of two weeks ago, that's it. And the reason that's important is because they had to prove to the FDA that the blood is not being pulled up into the handle, and is therefore contaminating the device and cross-contaminating, of course, with other patients, which some of the old devices did. Not good. So, [00:09:30] if the FDA was ever going to come in and look at a device, in my opinion, it should be the one that knocks holes in your face and has the possibility of transmitting disease from one patient to the other. Horror of all horrors. So, I'm not pushing hard for that. If you've got one that you trust is not cross-contaminating, go for it, but I'm highly recommending ... If you're ready to buy a new pen, they're the only ones that are FDA-approved at [00:10:00] the present moment. Others may be coming.

Voluma vs. Juvederm Ultra Plus

Now, back to the first part of the question, Voluma versus Juvederm Ultra Plus ... And any of you guys that have done hands-on training with me know that I tend to be more of a minimalist. Even if someone wants to have an exotic look, I like to achieve that with minimal amounts of material, and product, and puncture wounds, and such. And I think when you combine Juvederm Ultra Plus with [00:10:30] PRP, you get the effects of Voluma. I was lucky enough to train with [Mark Bailey 00:10:35] before Juvederm was approved in the US. We only had Restylane, and we started ... This was up in Canada, where I trained with him, and at the time, he was the top [inaudible 00:10:47] at least in North America, maybe the world. I'm not sure.

And we were using Juvederm Ultra Plus, like many of you, the way Voluma is taught now. [00:11:00] Of course, Voluma lasts longer, but I think that Juvederm lasts, at least a similar amount when you're combining the platelet plasma with it. I haven't proven that, but that's what I think. I also feel more comfortable using Juvederm all around the face, in tuning up the mouth and such. So it's just more versatile, but it can definitely be used, many of our people do use it and I really think it's very similar to internists [00:11:30] who has 200, maybe not that, let's say 50 different beta blocker, blood pressure medicines and hypertension use. But only has to become expert with one or two out of each class and the rest just be good with whatever it is you're using.

To expand upon that I don't think the research backs up as well combining plate rich plasma with Ray DS because just the structure of the gel, of the [00:12:00] liquid gel that's in an HA, I think provides a better substrate on which the pluripotency stem cells to migrate and mature verses the calcium hydroxide [inaudible 00:12:11] crystals that are in ADS. Not saying Radius is a bad product, I'm just saying when you're doing this, the fame part face lift where you are creating a sculpture that you have to augment and improved with plate rich plasma. I think using your favorite HA, whatever it is, and combining that with plate rich plasma works. So the answer to that question is, yes, is [00:12:30] the short answer.

Installed Base Profit Model

So let's go back to a little bit about profit, since we don't have as many questions this time. So we covered an update about the research. One question, let's talk about what install based profit is. So, some of you guys may have bought computers where they give you the printer. And course the reason they give you the printer is that now, you have [00:13:00] to buy the ink from them. And that know that they're going to make enough profit on the ink, that they can afford to give you the printer. So that's install base. So you put a base in and then people have to buy something to substitute. Something works with the razor, you buy the razor, that the Gillette razor, that cost you only 15 or 20 Bucks. But the next time you buy about refills it's $40 to get four little razors. [00:13:30] The thing is that people are more sensitive, this is an important point about this, I'm diving deeper than I've ever done with this model even in our hands on classes where we talk about this. But you are very sensitive to price point when you buy that initial thing.

Let's say you're buying printers, it costs more, they all have lots of different options. And so [00:14:00] because of that, you shop around to save $50 on the printer and look at all those options. This is very important, here. This is how people have made fortunes outside the medical world. So you shop like crazy, but now once you have the printer, you don't shop at all because there's one kind of in that fits it. And it's a lower priced item, maybe some of the more frugal people find some way to refill it or get a knock off version on Amazon, [00:14:30] but then it clogs your printer and go back to the brand name. You're just not as sensitive because you've already made the decision for the printer and now you need what fits it. Alright so hold that thought, you have the more sensitive higher priced item that you purchase and now you have a less expensive item that fits the thing you purchased. That's important, it fits the thing you purchased, so it's the thing you want. It's called [00:15:00] installed base. Here's where we get ripped off.

Another quick example is, you don't need another example you guys have got it. I will give you. Another one is you buy the Lamborghini and you have to buy the insurance. Now that one's interesting because two separate people sell it. You've got the Lamborghini guy who is flashy and good looking, or the woman who's good looking and [00:15:30] you buy the fricking car that costs more than a house. At least in some parts of Alabama. Then you gotta have insurance, and the person who sells the insurance to you is not so flashy. But selling insurance on a bunch on Lamborghini's and now he's getting, or she's getting money every month. Not so flashy, the insurance guy maybe he's flashy but he's probably going to have a big streak [00:16:00] of sort of accountant nerd in him and look straight laced and more secure and less flashy because he's selling security on that $150 000 investment. SO you have two people, one sells you the installation installed base, and the other one is you the thing that makes possibly more profit than selling the car, because its recurrent monthly.

Next Workshops with Live Models<---

Now here's doctors have been duped. It's so bad when you think [00:16:30] about this, imagine if you did this. I almost used the F word, because it makes me angry, because it happens every day. What if you sold the Lamborghini but you got paid $130 and then they walked down the street and gave the $150 000 to another person. How would that go? See [00:17:00] that's us. So you're riding and that other person gets to sell the insurance too. You just got to sell, you made 130 with one zero dollars to sell the Lamborghini, but then they go down the street to pick up the Lamborghini. You guys know where I'm going with this right? They go pick up the Lamborghini down the street, and that guy who didn't have anything to do with the sale, makes [00:17:30] the cash. And then gets recurrent payments on the same Lamborghini every month. Right? You know where I'm going?

I'll tell you exactly how it's happening. You go drive about a mile from here and a one quarter on a four lane highway, you'll see four pharmacies. All of those buildings much bigger than the local family practitioner, who's getting paid $130 to figure out what medicines grandmother needs with [00:18:00] three organs failing. And she goes down there and you better believe refilling those prescriptions, is like the Lamborghini literally, in price. And the pharmacies getting the money. So you have a big B, Walgreens, Win Dixie Pharmacy and Walmart Pharmacy literally all within a stone's throw. So that's installed base only we don't get it. Now I worked around that, in Alabama you can have a pharmacy and for awhile I did. And [00:18:30] you better believe, it put me right in cross hairs. So even though it's so called legal, you try doing it and if you think your colleagues are jealous of their turf, you better believe the pharmacies are jealous of your turf. Even though they can go do fricking free shots all day long, and put their toe on your turf. Control the money, you control power. And so when it's time to make the the laws. [00:19:00] Now I'm getting more off on the politics, but you guys know the physicians get their pay cut more than the pharmacies do. Okay. Anyway.

That's installed base, you get it? Now to understand it, and you understood it before, but now you see sort of how I'm diving into it. How do you do that with these procedures? You want a base and they're going to shop and kick the tires and "Do I want a Vampire facelift or I just need to get a facial [00:19:30] down the street from the whatever." And so they're price sensitive, "Do I get this light therapy or what do I get?" That's equivalent, of course, to shopping for the printer. The lost opportunity for us has been that once they do the thing, some of you guys are selling lots of aftercare products or the residuals, like the Lamborghini insurance. You're already doing that and you're making something match. [00:20:00] I'm not saying you quit doing that, but for eight years I have wanted a residual that match the base. So, we finally have it. And some of you guys already know it. You've seen it on my emails, but we have vampire skin therapy now, that is the after care products that fits our procedures. The first one we're rolling out, is altar, A-L-T-A-R. Play [00:20:30] on words. So this would be the aftercare product for the vampire facial.

 

I have a word of warning, though. One of our providers, I think it was Sylvia, sent me a picture where someone had some sort of something put on their face and then micro-needled and had a reaction [Facial Allergic Granulomatous Reaction and Systemic Hypersensitivity Associated With Microneedle Therapy]. I haven't seen the person, so I wasn't sure if it was urticaria [or something else].

 

 

 

 

 

There are two cases we've had in our group and there's a couple [00:21:00] of mentions in the research about urticaria happening from your PRP. We're not sure why that happens, but you just Medrol Dose pack, it goes away.

We've had it in one one face and one [inaudible 00:21:10] in the inner. But this look like it could be actually some sort of granulomatous thing and there's an article in the research showing that, that happens. And it's treated with antibiotics & steroids. And it's because your micro-needling actual particles into the face.

So, the protocol [00:21:30] for this would be doing your micro-needling. If you have an HA that you're using, that's fine micro-needling that, but nothing particulate, including this cream. Even though I think you could probably micro-needle it in on the foot side, I do not recommend it. We have not checked that out. The research that goes with this, if you go to our, let me see if he's on the call. He [00:22:00] didn't make it today, but we had him, Dr Glassman. I'll get him on one of the future calls. He brought these to me, and we have a ... Thanks to our collaboration with Dr. Glassman, we have the exclusive on the patent to the material that's an extract that has been proven in clinical trials, and a $2 million NIH study looking at wound healing to decrease the numbers of senescent cells and increase [inaudible 00:22:27] activity and such.

So if [00:22:30] you want to see the details on that, here's some of the research. I actually found some before and after pictures from the research which I'll post on the recording here.

 

 

 

This is the guy who invented it. He's got a pedigree that can with anybody, multiple research studies, and we have the exclusive on this. So now you have many blades that match the razor and you can offer, alter, a Vampire Skincare [00:23:00] therapy as an aftercare product after the facial or the face lift.

So the protocol would be you usual way of cleansing the skin, I vote for hydrochlorous, which you get on Amazon. It's very cheap, and I think it's easier to use, it doesn't irritate the eyes.

Hydrochlorous Acid

Vampire Facial® Protocol that Includes Altar™

Whatever you do to cleanse the skin. You apply your PRP micro ... And the plus, minus HA micro needle it in, and then your PRP after that, and then alter [00:23:30] on top of that, and then they use that, could use it, perpetually. If they're prone to acne, they should not, cause it has ... We're not sure what it does with acne, but if you have oily skin you'll find it has a heavier feel to it. The before and after pictures on people have who have been radiated, or have dry, cracky skin from either age or exposure to the cold and heat and such, or even some psoriasis and [00:24:00] with diabetic wounds, are absolutely amazing. So, anyway, that's the protocol and this is now install based.

1. Cleanse the skin (after topical anesthetic cream).
2. Apply PRP
3. Microneedle
4. Apply PRP
5. Apply Altar™ twice a day for 3 weeks then every night perpetually (suggested retail is $147 per 1.7 ounces).

Where to buy Altar™ (click)<--

 

 

 

 

 

 

We'll be making install based products for the O Shot, for hair, for other things. So stay tuned, we'll probably have a peptide cream and the, my ... The reason it's taken me eight years is because, in my opinion, nothing really was new under the sun that I thought was up to par. [00:24:30] I've owned the name Vampire Skin Therapy for at least five years, and ... But I just didn't think anything was up to par.

So to buy this, I'm going to put a link in here. The suggested retail price, which you know what you do in your privacy, if you want to give it to your mother-in-law or sell it occasionally to a special person for less, or give it as a bonus, that's fine. But that should be the one off, and the only advertised retail price should be $147 [00:25:00] or more. That's for the 1.7 ounces, and that gives you over doubling of your ... You'll see, you could do the math on it. But it gives you more profit than you get on any of your other products. Not saying throw everything else out, but there you have it. That's our new thing and ...

Oh, last thing, we have some people with pretty nice audiences in the million range of followers. A couple of celebrities that are going to [00:25:30] be talking about this in the next week or two. We've got two press ... Possible press publishing that will happen. We're sending samples to a couple of fairly popular magazines, print and online. So this is not ... It will not ship until April the 12th. So if you order it, they won't bill your credit card until they ship it. It does go throughout Europe if you're listening to this, and you can get ... [00:26:00] If you're not in Afghanistan or something where you're shooting at people, we can get it to you, and I think that's about it.

Let's do another question or two and then we'll shut it down.

Can you do the O-Shot® on  someone with ITP?

I get this a lot. I have a patient with ITP. Her platelet count runs in the 70 to 90,000 and she's interested in having the O Shot. You know, here's the thing, we're still obviously in the early stages of proving how things [00:26:30] work, and I honestly don't know. My feeling is that you have nothing to lose by trying with this woman, and a lot to gain.

My warning is this, if you're starting out, stick to the easy, easier cases. Nothing is 100%, because I highly recommend that if someone is not happy with what you do, you give [00:27:00] them every penny that they've paid to you back. And if you're going to do that, and you're treating only the difficult cases that we're not sure how things are going to go, and you're giving people their money back, you'll be frustrated. Especially if you haven't been doing it long enough to see it's benefits. You don't even know with confidence that it's helpful.

So stick to the easy cases with the O Shot, which is the younger to ... Younger as far as structure goes. Women [00:27:30] who have ... Younger to mean is, you know you could be 70, but you usually it's the 35 to 55 year old woman who her cervix is not falling out of her vagina, and she's got incontinence. She can have an orgasm, but it's not what it used to be. She's got dyspareunia, because we do well with that for some reason, but it's not a surgical cause of dyspareunia, and Lichen Sclerosus. Those are easy wins [00:28:00] for us, and course they're difficult wins for other people so that's why people are going to like our stuff.

Something like this, I would treat it, and I often do treat it just because I want to help people. What you guys do, I don't see a downside for it. But just if you're new to the groove, I would stay away from the harder cases. For example, we've also had some anecdotal reports treacle incontinence women when they've had the big tearing. Things that can go in the grade [00:28:30] four or five, I think, when they a postpartum tear. And we have ... I know of two very definite, excuse me, three very definite anecdotal reports of that improving after one, in one case three different injections to help that. So anyway, stick to the easy cases.

Calcium Chloride Sources and Techniques

So Terry says, "On the calcium chloride question." And there's a video out there where I show to transfer it from the ampules in your crash cart in to a 10 CC syringe. Can you just leave it in the glass ampule instead of transferring it? You could, I think it's just obviously I think a cut testament to how careful our FDA is when it's difficult [00:29:30] to find people to serve you salt water, which is of course what calcium chloride is.

Source of Calcium Chloride <--

But I usually transfer it, of course, to a sterile syringe, cap it, and then I just don't let anything that's not sterile touch that and use it as a multi-dose vial. But I can usually get vials from McGuff and many of the people in the group are telling me they also will get it, so go to our supply list and check out McGuff if you're in the US. Those outside the US probably [00:30:00] don't have as much trouble coming up with that.

Let's see if ... I don't see any other questions, and I want to thank you for being here and posting your comments. It would help, you know I don't want to be the sole source, I want to hopefully do a lot with helping you guys talk to each other, so anything that gets posted here, gets discussed, if not before at least during our conversations. I'll post links to everything we talked about, and you guys have a wonderful week. Thank you very much.

Charles Runels, MD
Charles Runels, MD (photo)

Cellular Medicine Association
1-888-920-5311

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