Are Placenta “Stem Cell” Shots Actually Stem Cells? | Conversations in Regen Ep. 20

Orthobiologics is evolving fast—but are placenta stem cell injections really delivering stem cells, or is the science being misunderstood? Explore the evidence behind orthobiologics.
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This educational discussion is primarily intended for physicians, clinicians, and medical professionals interested in orthobiologics injections and regenerative medicine. However, patients and curious viewers are absolutely welcome to listen and learn from the conversation.

In this episode, Dr. Ariana DeMers, the Queen of Business Orthobiologics, sits down with Dr. Kristin Oliver to unpack one of the most debated topics in regenerative medicine: placenta stem cell therapy. As more clinics market placenta-derived products as “stem cell shots,” doctors are left asking an important question—does placenta have stem cells in the final injectable product?

Through a thoughtful, physician-focused discussion, they examine the science, regulatory considerations, and clinical realities surrounding placenta stem cell injections and other orthobiologics injections. The conversation explores how these products are sourced, what the research actually shows, and why the terminology used in marketing can sometimes blur the line between science and assumption. For clinicians navigating patient demand for “stem cell shots,” this episode offers clarity on how to evaluate biologic products, communicate evidence to patients, and practice ethically within the growing field of orthobiologics.

Building a successful cash-based orthobiologic practice is not a single decision. It is a series of the right decisions made in the right order. The Business of Orthobiologics offers three distinct programs designed to meet physicians at different stages of readiness — whether you are just beginning to explore PRP, ready to build a full practice system, or committed to going all-in on a comprehensive transformation.

Learn More here: https://thebusinessoforthobiologics.com/programs-explanation 

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Transcript

SPEAKER_02 0:00

You don't want your old crusty dried up cells. You want new baby cells. And I'm like, oh my goodness. Really? What this is this is really happening. And you know, people are on their edge of their seats. They're in a desperate situation. They're looking for anything to make their knee better.

SPEAKER_00 0:19

We realized this, they were telling us when they came to the office with the marketing material, those cell numbers were done on the freshly harvested product. More and more people kind of got on board with hey, these products have some growth factor in them, but they aren't really stem cell products. For those of you that are out there that don't understand that, are there guys in black showing up at your office and putting you in cuffs and taking you to the jail? Now, usually it's just a warning saying, hey, what you're doing, these are the things we don't agree with, these are the things you need to clean up.

SPEAKER_02 0:55

Welcome, welcome, welcome. We are so happy to have you here. This is Conversations in Regenerative Medicine where we are exploring the frontiers of PRP with the BMC, with MFAT, and maybe some other things today is very exciting. And so, you know, this is a little bit of a different experience. We are absolutely loving this, and this is more of a conversation rather than a lecture. And this is maybe giving you some insights that may shape your intervention orthobiologics and tackle some of the controversial pieces of the puzzle. So for those of you who don't know me, I'm Dr. Ariana DeMers. I am a board-certified fellowship train, orthopedic sports medicine surgeon, and regenerative medicine aficionado. I do a lot of training and educating in orthobiologics and ultrasound. And I have successfully moved my practice away from commercial insurance. And I am most passionate about helping doctors to incorporate orthobiologics and cash-based practice seamlessly. So I am so, so happy to introduce it to you all. She needs no introduction, but joining us tonight is Kristen Oliver. She is a board-certified family medicine, a physician, fellowship trained in sports medicine, has her master's in public health, is the co-founder of Blue Tell Medical Group, who greater than 15 years ago, pioneer in the field, leader in regenerative orthopedics, over 25,000 orthobiologic patients treated. So man, I'm keep I'm trying to keep speed with you. Expertise in PRP, bone marrow concentrate, lipoaspora, and of course advanced musculoskeletal ultrasound. So holy cow, I'm so glad to have you here. I'm really looking forward to our conversation. It's gonna be so much fun. For everybody that's here today, thanks for joining me. This is always so much fun. I really love having a fireside chat, pulling back the curtain, and getting to know us, exploring controversial topics in orthobiologics, regenerative medicine, and hopefully gaining some actionable insights that you can implement in your own practice immediately. At the end, we will have a live QA session to get all of your burning questions answered. So I do believe that orthobiologic treatments will be first-line treatment for musculoskeletal care in the next five years. We are hitting an inflection point where the train is leaving at the station. And if you are not actively offering these uh treatments to your patients, you gotta get on the train. It is leaving. So the thing about the cash-based practice and an integration of orthobiologics in your existing practice is this is hard. And having a successful orthobiologics practice sometimes uncovers these anxieties about the fact that maybe, you know, I don't know all of the things. Maybe I, you know, tried some things and they either did or did not work. Maybe we don't know all of the science or the latest science, techniques, cash-based business, marketing sales. And maybe you just thought I'm just not good at this business thing. But honestly, it's not our fault. We just didn't learn this in school. It is a learnable skill. We just didn't learn this one. So don't stress out. This is absolutely doable, and I'm sure some of you are really wondering how do I create a successful orthobiologic practice so we can capitalize on this four billion dollar orthobiologics market out there. We do deserve to win. So why are we struggling, right? So if you're struggling with anything, because we're gonna go over this, but tell me the most difficult thing that people are you're you're struggling with right now, and and we'll maybe address that as we go forward. So the question is how to win, right? We are gonna be talking about science today, but we also need to consider how we talk about this with our patients. So we all win. The doctors win, the patients win, our practice wins, and so how do we do that? Well, we need a system, and we're not gonna go over this entire system today, but we are gonna get a little further down the journey to be wildly successful in your orthobiological practice. So let's get down to really starting a little bit more on this orthobiologic knowledge. Alright, so we have questions for Kristen. This is uh what we're here for. We're gonna ask her some really interesting, fun things. This is a subject that is near and dear to her heart, and she is passionate about really, you know, knocking the dust off this stuff and and getting down to business. So the first question I have is are most stem cell claims in placenta and cord blood products scientifically false, or are they just strategically vague enough to avoid the accountability that our government has placed?

SPEAKER_00 6:49

That's actually a great question. If I can, I'd love to break that into kind of two facets. I think there's the manufacturing facet, like the manufacturer issue, and then there's the clinical issue. So, you know, I can tell you back in like yeah, 2018, 19-ish, when this stuff first came to market, we would have reps come from the companies into the office, and they would show us these amazing numbers of stem cells that were in this little bottle of product. And, you know, we started to use it. One of my partners actually started to use it to begin with. He was sort of like the hey, let's let's let Mikey try it. And but we kept good data on it, and really he wasn't getting improvement for more than about six months, if that intra-articulate, which primarily intra-articulate for osteoarthritis. And we had a relationship with Franciscan University and sent samples to them. And the main PhD there ran through those, and you know, after culturing, there were no living cells. So we realized this what the they were telling us when they came to the office with the marketing material, those cell numbers were done on the freshly harvested product, not after it had been, you know, lyophilized, frozen, irradiated, etc. And then kind of shortly after that, uh Lisa Fortier did a study on Amnion, same thing. You had IOF doing it, Albera Pinero actually had a great paper on it. So more and more people kind of got on board with hey, these products have some growth factor in them, but they aren't really stem cell products. Okay, so what's happened in the last year or two is that a few of the manufacturing companies like Lux and NUVIDIA, not Nvidia, NUVIDIA, and I think BioXTech is another one. They received formal FDA warning letters. And you know, for those of you that are out there don't that don't understand that, like what does that mean? Are there guys in black showing up at your office and putting you in cuffs and taking you to the jail? No, usually it's just a warning saying, hey, what you're doing, these are the things we don't agree with, these are the things you need to clean up. So if you go out there and you look at most of the websites now, like Mimedex, Vivax, I mean, those sites are really clean. The websites are extremely clean. Their written marketing material is very clean. They don't talk about stem cells, they don't talk about applications orthopedically except for wound care. So they're staying within that homologous, minimally manipulated thing they're supposed to. But I don't know, like, do they still stay within that framework in the office? And I don't know if you've had any exposure to them. Might be interesting to see.

SPEAKER_02 9:30

Yeah, so I think that's so interesting. So I I appreciate the way that you break that down, you know, like okay, is the company, you know, making false claims or just being super vague so they don't get a slap on the wrist? The answer is clearly yes, right? Now, you know, I have some doctors who are like, this is the hill they're they're they're gonna die on. They're like, my patients do so good. Like, it's not fair. Um, and then there are, you know, so the question is number one, is there stem cells in it? Pretty across the board, it seems like not exactly. Is there growth factors in it? Yes, yes. Now, so what I talk to my patients about, I'm like, because they're like, oh, I want that that cord blood stuff, I want the Wharton's jelly. I'm like, well, okay, let's back up. Clearly, you know, there has been a struggle to demonstrate that there is viable cells. Okay, so there's growth factors. Cool. When would this be the best idea? Okay, well, what if my human doesn't have good growth factors? Maybe they've had irradiation, maybe they are not metabolically well. Then we start to think, okay, this might be viable. Now, the the second part is is it legal?

SPEAKER_00 10:54

I don't think good question.

SPEAKER_02 10:55

I don't think so. Yeah, right.

SPEAKER_00 10:57

Yeah, so I would say that the biggest issue has become kind of this gray zone, right? Like, and there's light gray and there's dark gray, right? There's this big, huge gray zone, especially in states now like Florida, Utah, which was one of the first adopters of placental cells, which is where I live. And why why one of the why it's sort of near and near to my heart, and also places like Wyoming, which is very forward in the, you know, some of the my own cells are my own cells, right? Like I can do with them what I want to. So, but again, from the amnion perspective, I think there's value in those patients who are thrombocytocytopenic for some reason. They don't have signaling, they don't have growth factor. I think it's a viable product for those individuals, but it shouldn't be marketed as a stem cell product. Which brings me to the second part, which is the clinical part of this question. And, you know, I like to believe the best in everyone and that the wool is just getting pulled over the eyes of the practitioner and that they believe what we did to start with, and that was hey, there's all these stem cells in there because I'm getting this white paper and I don't realize it's on the pre-frozen product. But when you get right down to it, if you look at the number of businesses in states like Florida, Utah, Texas, that are, you know, there's stem cells all over their websites and they're using an umbilical product, a placental product. And we know that they may have a few cells, but most studies have shown no significant living cells.

SPEAKER_02 12:23

Yeah.

SPEAKER_00 12:24

Not to say, I mean, I don't mind if you market it as a growth factor product, right? Say to people, hey, if you don't want to get your blood drawn, right? You know, you can go and I can shoot this little bottle in there.

SPEAKER_02 12:34

Yeah. And and is it legal? Probably not. Who's gonna be in trouble? Probably both of you. Um, if you try to have Medicare pay for it, you're definitely gonna get clawbacks, so please don't do that. And so it is really interesting, right? And I think that the the dichotomy of 351 pathway versus 361 pathway, 351 pathway for FDA approval is a drug. And so, if you have not jumped through all the hoops, done all of the paperwork, you know, done all of the studies, done all of the FDA trials, you're not gonna go down that 351 pathway. And so everybody is really wanting to push for the 361 pathway. And if you're in a 361 pathway, you have to prove that you're mentally manipulated, that it's homologous use. I just talked to a doctor yesterday, he was like, Well, it's homologous use, it's it's umbilical cord for cushioning. I'm like, Okay, so Connie a couple years ago stood up and said, For half of the population, that may be true. If you've ever had umbilical cord within you and you've been pregnant or you've had a fetus within you, that may be considered homologous to use. For those of you who have never had been pregnant, that is very unlikely to be homologous use. So, you know, how how far do you want to stretch that, right? How far are you willing to stretch it? And at what point? If you are making, you know, millions and millions of dollars, some companies that is the price of doing business to fight with the FDA and to close down, you know, set up shop somewhere else and then rebrand, right?

SPEAKER_00 14:28

So yeah, totally, and you know, a lot of the times, like when this these first came out, what you really saw was a host. You there were a few companies which have now been sanctioned, actually, like closed by the FDA, that would market to chiropractors, and nothing against chiropractors. I mean, some of my best referral sources are chiropractors, and you know, they would market to them, they'd set this up in their shop, they'd provide them with marketing materials, they would provide, they they'd take that, they would have a nurse practitioner that the provider, the chiropractor sort of affiliated with, that nurse practitioner would go for a weekend course, learn how to do ultrasound, come back in, and then there was an individual who kind of was the salesperson in the office, sold it, they did the injection. And most of the time, in many of them, in many of the states where the nurse practitioner or physician assistant couldn't work with, you know, couldn't work uh separately from a, you know, couldn't had to work, didn't have to could work separately and individually without oversight from a physician, they could just do it. In the ones where they needed a physician, they would just pay a physician per hour. Like in Columbia, we had this, and there was a guy who was just like uh he'd done research for 25 years. Like he had never he hadn't taken care of a patient since residency, and he was their overseer. So it's a little shady, right?

SPEAKER_02 15:47

Yeah, yeah. So there's some really good questions here. You know, floor there's some questions here that are really interesting. Florida requires third-party live cell viability analysis, and and he says, I believe Wyoming too. Thoughts, yeah, awesome. Let's have that, you know, thought live cell and viability analysis through third-party testing. Great. Yes, and you know, GMP manufacturing facilities, absolutely. Now, is it FDA clear or approved? Because a lot of these companies, I just had one in my office last week telling me that it was FDA approved. It's clearly not, and so and I'm in California, so that's a risky and risky little biscuit.

SPEAKER_00 16:37

Yeah, um, and the question becomes you know, those states, Florida, and I get that point. So I actually read through the entire law, and Florida does require that, but the it requires it of the manufacturer, okay, not of the provider. But the question becomes I mean, if we if we believe the studies that have been done on these products previously by third parties that aren't, you know, interested in the monetary aspect, the question becomes is all like where where are those studies by these companies that show viability after thawing, right? I I don't see them out there. And if if Florida requires them, is the manufacturer actually providing them to the physician? I don't work in Florida, I don't know. In Utah, they're primarily used at this point for aesthetics.

SPEAKER_01 17:21

Yeah.

SPEAKER_00 17:22

Yeah, like the aesthetics market here is stupid. So if you want to make money here, be an aesthetician or a dermatologist.

SPEAKER_02 17:29

So and and there's a lot of discussion and that there's differential, you know, there's differential license regarding, you know, topical injections versus intra-articular injections from just from a licensing perspective.

SPEAKER_00 17:43

Correct.

SPEAKER_02 17:43

Yes, yeah.

SPEAKER_00 17:44

And they are FDA approved for certain applications. So they are FDA approved, a lot of these for wound care, for wound healing, for use, you know, orthopedic surgery as a wound application. And some there's some others that are used as matrices in the orthopedic market. And interestingly enough, there's a company called Renew, R-EN U, and they're actually they're formally applying to the FDA here in early 2026 for a BLA, so a biologic licensing application. They kind of put in this rolling initial thing in in 2025, and it's for osteoarthritis. So it'll be sort of interesting to see what data they show. But again, like you said, there's a growth factor.

SPEAKER_02 18:25

Absolutely. So, you know, everybody gets a little riled up, and it is there's there's I think people are on both sides of the fence, right? I'm having this a very large uh conversation in the chat, which I'll share with you.

SPEAKER_00 18:45

Am I getting hate mail?

SPEAKER_02 18:47

Nobody's gonna get hate mail, and here's why is honestly, we're just talking we're trying to figure it out things that what I what I hope we take away from this is that the manufacturers are in this to make money, right? Who gets caught in the middle is the physicians, right? And and we're just trying, we're trying to keep our clinic afloat, do right by our patients, and follow as much guidance as we know how to how to follow. And when states and uh you know the FDA is is giving varying data, it it's just hard to sometimes figure out what the right and it does vary by state. So it it is it is really fascinating to me how much excitement people have around this topic, and I think there's a lot of rhetoric that is you know a little bit more inflammatory. That's not what we're doing here today. I think what we want to talk about is you know, there are bigger problems, right? Is like okay, so the bigger is the bigger problem that the product, the claims, or the business model that incentivizes overselling, right? Does is it is it because it's a cash-based service and it's moderately unregulated, or you know, some people would call it the wild, wild west or wild, wild southeast? You know, I'm I'm in Florida a lot, and they do have some interesting perspectives on these things and requirements, not only by the manufacturer, but and then the question is is is it is the manufacturer doing what they say they're doing? And and is the incentive there for them to be on the up and up?

SPEAKER_00 20:46

Yeah, I mean, I think if I look at that question, I mean it's tough because it's all kind of intertwined, but I would say that the product is not a bad product. I I'm nothing against the product. I think the product is a great product, I think it's great. It's it's just the question is should it be marketed as a stem cell product? People have issues with us marketing bone marrow concentrate as a stem cell, right? They're like, oh, there's a beer, only just a teeny bit of stem cells in there. I get that. There only is. If you tell your patient that, great. But if you're going to your patient and you're saying, I'm giving you this, if you're having a seminar and you're telling your patients, hey, I'm giving you, I'm choosing this placental product and promoting it, let's say we're gonna say birth tissue product, and I'm doing it because these cells are young and your cells are old, and your cells are are not are worthless. Why wouldn't you want a nice young cell versus an old cell? And to me, that is the business model issue, right? It's the but the business model kind of relies on the claim. Although I believe the product is a good product, it is primarily, unless it's proven so before provided to the practitioner, it's primarily a growth factor product, sort of like PRP.

SPEAKER_02 21:57

Yeah, yeah, absolutely. So You know, and then you mix money into it, and everyone like starts to have a coronary about money. Like, I think as a whole, the general public has an issue with physicians making money. They think we're all rich. If they looked at my Medicare reimbursement, they'd fall over right.

SPEAKER_00 22:23

They could only read their own EOBs.

SPEAKER_02 22:26

Even other physicians, I'm quite vocal on what I get paid to do a knee replacement. You know, $1,100 for the surgery, for the pre-op and the 90-day global is not very much.

SPEAKER_01 22:38

No, it's quite shocking.

SPEAKER_02 22:40

You know, one of my anesthesiologist friends was like, didn't you miss a zero? Like, gosh, I really wish so, but no, you know, it's not eleven thousand dollars, it's eleven hundred. And so anytime that that question of money, I think it starts to get a little bit more dicey. So clearly, we still have questions. So when patients come in and asking for that, I want those baby cells, I want those placental stem cell shots. Is it ethical to offer PRP as an alternative? Or should we be having a more nuanced long, you know, conversation about what actually is a stem cell? Is it a MSC? Is it a mesyncal stem cell? Is it a medicinal signaling cell? Is it autologous? Is it allogenaic? How is it processed? How how do we know? You know, that that's a big conversation. And and what we don't want is we don't want the bait and switch. And is saying, oh well, yeah, I want that stem cell thing, and you're like, okay, here you go, here's some PRP. Is that a little risky or is that onus on us to try to crystallize the the differences and the nuances in in the the landscape of orthobiologics, both autologous and allogenaic?

SPEAKER_00 24:04

Yeah, I mean that's good. I I don't think it's a bait and switch because I think of a bait and switch like someone comes in wanting like a Mazda, right? And you and you get them to buy a Maserati. I mean, to me, that's sort of a bait and switch. Yeah, yeah, exactly. To them, correct. But I feel like to me, it's ethical to explain it to them. The problem is how do you approach it without throwing a colleague under the bus? Right. I'm never someone, I'm like, if you can't say something good, just don't say anything at all. And so how do you do that and be respectful? Because if you all of a sudden, me personally, when I would deal with this exact question in my office, you know, multiple times, you know, I would say they would ask me, and you know, I would have to very delicately talk to them about placental cells. I'd explain I can give you significant literature if they can come back with literature that shows you what is injected after it thaws. And I explained the freeze thaw, gave them some websites, and you know, there were a few patients that despite the conversation, because you know, you don't want to spend an hour and a half in there getting on your soapbox, right? Because they aren't going to appreciate that, and you're not gonna appreciate that, and your staff isn't gonna appreciate that. But you want to be able to say, you know, ethically, I have to tell you that you know, those are great products, but they contain growth factor, which we can also get from your own platelets, okay, and probably at the same cost and without with less risk because it's homologous, even less cost depending upon what device you're using. So, you know, to me, it's sort of that ethically. I think I need to tell them. I don't feel bad telling them, but I I want to do it in a kind of a delicate way.

SPEAKER_02 25:42

Absolutely, absolutely. You know, I think that I've been to one of those conferences you're telling me about. Really?

SPEAKER_00 25:50

Crazy.

SPEAKER_02 25:51

Oh my goodness. I snuck in the back door and I was sitting there and he's like, you don't want your old crusty, dried up cells. You want new baby cells. And I'm like, oh my goodness, really? What this is this is really happening. And you know, people are on the edge of their seats, they're they're in a desperate situation. They're like they they're looking for anything to make their knee better. And I'm just thinking, oh my goodness, this is what this is what is happening. You know, it was someone coming to my town, didn't live in my town, was recruiting to a different town. And it's like, oh my goodness. And then unfortunately, I get the I get the the down the line effect where they've come in, they've spent, you know, their life savings on this, and they're no better off.

SPEAKER_00 26:40

They're no better. I know. It's very sad. So you're just trying to, and then it gives honestly a bad name to orthobiologics in general. You know, people sit around and they talk at like the canasta table or the bridge table or the hair salon, and you know, they'll say, Oh, don't do that. My friend, you know, Joyce had that done and it didn't work, and it turns out, you know. So there's sort of this, like, I don't know, it's it's sort of, you know, the orthobiologics in general, when you consider all the factors that we have to put into success, from the system to the practitioner to checking cell cap. I mean, all those things are so variable. And then you add this other thing in, and it just seems like it muddies the water more. And then, you know, when you have different states with different laws, then okay, I'm a practitioner. I work in Texas, Utah, and I'm being told it's okay as long as I post a sign that's no, like in Utah, you have to post a sign that's I think it's eight and a half by 11, no smaller. And the font that says this isn't a non-FDA, you know, approved procedure or device or, you know, I should say application, that that has to be in print that is no smaller than like a 40 font. I mean, there's some interesting rules, but every state's a little different, and then the question really becomes does the state overrule the federal government, which is no in most cases, right? Although I may be wrong, maybe the state does rule.

SPEAKER_02 28:04

Yeah, yeah, yeah. I mean, man, I I'm this is such an interesting time to be, you know, talking about FDA, talking about state versus federal. Like this is all very fluid right now. So I, you know, what is true today may not be true tomorrow. So I just I think the onus is on us to have as much have as much information as we can gather and uh you know seek good counsel. I think the council, you know, I have my uh license in Florida and I have a license in California, and so those states are not the same, those restrictions are not the same at all. And so when I seek counsel from qualified persons, it's all about protection of my patient, adequate discussion, and I'm I'm gonna put this out there, and I think we're all a little remiss in this off-label discussion. So when you dig into using things off label, we have to it the onus and the the responsibility to be able to use something off label is very uh important for us to go over why it is that we think this seems like a reasonable option to use off-label, what the the clear risks and benefits of this off-label use would be for this patient, and what is the the relevant literature that would support this off-label use? But I can tell you I have not had adequate conversations about off-label use for medications that we use off-label use all the time, right? So we use gabapentin off-label for pain all the time, but I will tell you, I have not had that conversation clearly when I prescribe gabapentin, right? I say it is a nerve medication, it was designed for seizures, um, and we use it for pain. I don't produce them with the research studies that support this conversation about off-label use. I think the onus is on me and I probably should, right? As we as we delve into treatments that are have an indication and we're doing it off-label, right? The PRP, you know, for with a 510K clear device, we s the onus is on us to absolutely offer that ethical and and scientific realm of how we came to this conclusion that we should be considering this off-label application for our patient use.

SPEAKER_00 30:51

Yeah, and I think also not only discussing it in the, you know, when you say off-label, the patients don't quite get it. So actually, Gabifentin is what I used as an example. I would say, so this is off-label. PRP can be used for the same reason if I'm in the operating room, right? Because otherwise, or BMC or MFAP, you know, so the 510K says orthopedic surgery. And so if it's an office-based procedure, you know, you are strictly using it off label, but that doesn't mean it's so I say there's this medicine, we call it, you know, gapapentin and the ornirontin, and it's used for seizures, but we found out it helped for pain. So now we can use it for pain. That and I explain the cost of getting a 510K for one application so that drug companies often get it for one and then are able to apply it off label, and it's on the honors of the physician. It's our decision to say this is safe and this is safe and potentially effective.

SPEAKER_02 31:46

Yeah, it's you know, it is the responsibility lies on us to help safeguard our patients. So, yeah, absolutely. This is so I I love to talk about this. It's it's so you know, clearly we need to have more questions.

SPEAKER_00 32:01

Well, and you know, I really think there's a lot of gray. Like I said before, I think the hardest part of this, when you add in all the states now having their own, there's like this gray that's gone from light gray to dark gray. And so, you know, you're sort of like like my accountant always says, it's okay to sit on the fence and it's okay to kind of lean on the fence, but you don't want to jump over the fence, right? So, where is that line?

SPEAKER_02 32:22

Yeah, yeah, absolutely. You know, the the question that I have is like, what is the hardest truth doctors need to hear about why patients buy these offers even when the evidence is thin or like very, very scant, right? Like why, and we were talking about the marketing, this age bias, like oh, younger cells must be better. You know, so how how do we support our patients, but also how help our patients understand that this may or may not be there may not be very much data, but the data we do have points to that maybe it's helpful or maybe it's not helpful, right? So help our patients.

SPEAKER_00 33:12

Yeah, I think the hardest part is is the human nature in the fact that you know we all want a magic pill, we all want an easy route. I mean, we all want to hear, oh gosh, you know, the idea I go to a seminar or an office and they tell me my cells are old. Well, part of the fact, I mean, I feel old. I'm injured, I don't feel well, I have arthritis, I feel old, I am old. So why would I use my old crummy cells when I can use some super fresh baby cells, right? So it sort of hits at the emotional core of the patient who's, you know, not feeling as vital as they did at 21. I think there's that emotional component to it. And, you know, the patient is human. And I don't think it's unreasonable to for someone who doesn't have the education or the data or the ability to look at the data in front of them or like being given possibly false or slightly manipulated data. I don't think it's wrong for them to want easy fast. You open the your in and out. I mean, let's put it this way, Ariana. If I could find a viable way to do something in 10 minutes in my office and provide the same quality, scientifically you know, proven quality that I'm giving them, the same amount of growth. Why wouldn't I do it?

SPEAKER_02 34:27

Yeah, no, absolutely. Yeah, you know, if you are seeing 10 patients a day and you can do it in 10 minutes, you instead of 10 hours, okay, yeah, like sign me up. But then what I'm gonna do with my other eight and a half hours, yeah, maybe I'll take a nap or something. It is human nature, and we are always hoping for that magic bullet, hoping that it's gonna be less hard somehow. Same with like if you look at the weight loss industry, right? Like everybody's looking for that magic bullet, and it's like, well, diet and exercise is also helpful, you know, and the GLP ones are uh one part of it. Do they work? Yes, they do. Do they have you know some issues? Yes, they do. If you don't change anything else about your diet and you still eat hojos and Doritos, if you stop taking the GLP, do you gain all the weight back? Absolutely, right? It's not a magic bullet, and so we use these injection-based therapies in a similar way. This is not like a magic bullet. I I can't turn back the clock to when you were 21. No one has shown that any of these injections, whether it be PRP, BMC, MFAT, Wharton's jelly, culture expanded cells, can turn the clock all the way back. We just are not there yet, right? This whole, you know, issue about cellular senescence, this whole there's so much to unpack that I I always tease. We're we're we're now getting to the beginning of the beginning, you know.

SPEAKER_00 36:06

Exactly correct. I think I agree with you. No, and if you look at offshore clinics where they used to use autologous cells and culture expand, they now use birth products like placenta and they culture expand. And I was down in Brazil, like I don't know, like 15 years ago, maybe, and they had a clinic there where they would use birth product cells, and they had this amazing like little freezer that would bring them from they had a way to thaw them without lysing the cells. And that the freeze thaw process is where most of the living cells are killed. So, but this little device they had was like, you know, $585,000 or something. So some crazy amount. So I mean, the technology is out there, it's just we don't have it in our clinics.

SPEAKER_02 36:46

Right, right. And you know, in the US, there is a number of companies that are in that FDA trial for Culture Expanded. There's a number of companies that are pushing for acellular products, both you know, autologous and allogenaic, and they're going through those channels to be able to do that. We've had a significant number of hurdles. A lot of the companies are still in development. You know, there's now a right to try act where if they pass the FDA safety data portion of their trial, now the US public has a right to try it for life and threatening disease. So it is coming along, but I think you know, we're not there. And you know, then now there's you know, the there's there's so many questions around who to trust and and who to believe. I just got a I was just telling you this flyer, like the the words on the flyer are pure nonsense, like this is not even like real in these things don't exist, these are made-up terms purely for marketing, and so for that, from an ethical perspective, it's like shoot man, like if you are not even using normal scientific, like I can't I can't buy your pro like what else have you fudged? What else have you not done your homework with? And and and really the people always ask me why it is that they're allowed to market. Well, they're not, right? But the question that I have for everybody, and and you know, we all do this: how many people speed in their car?

SPEAKER_00 38:45

That's a great question.

SPEAKER_02 38:47

Like everybody, right? Everybody is it legal? No, no, it is not legal, right? We are breaking the law when we go over the speed limit, right? But what is the ramifications? Are you gonna get caught? Even if you got caught, uh is it is it gonna be detrimental enough to curb that behavior? Same thing in this space. What's what is the downside, right? Minimal. I was just reading some of these award letters where they were like, Oh, we're so sorry, FDA, we did bad, and they were ordered to pay, it was like 0.1% of their revenue.

SPEAKER_00 39:29

Yeah, it's it's it's really, yeah, it is really that the the it's not a big stick, right? Right. And and even then, if you look at the plethora of people who are, even if you're not in a gray state, right? If you're in, I don't know, California, for example.

SPEAKER_01 39:44

Let's say California, California.

SPEAKER_00 39:46

You know, we're not in a gray state, but people are still doing it. And a lot of it is sort of like, well, Joe down the streets doing it, he hasn't gotten caught, kind of thing. And and the truth is, you know, theoretically, if you get a letter, you keep doing it, and you snub your nose in the FGA space, you're gonna have a problem, right? But if you are doing it and then you comply thereafter, you have to change your business model. But in the end, we should be doing what we think is right for the patient. And it's hard if you're getting mixed messages in regards to what's the most valuable way to approach something. And I have a feeling it's gonna get a little more murky before it gets clear. So I'm interested to see what comes down the line.

SPEAKER_02 40:26

Yeah, you know, we always talk, and there were some conversations in the in the chat about the fact that there's some bad actors in every field, right? And there are some clinicians that are knowingly like overselling because it's profitable, like, oh, these baby cells are gonna do great, um, as they're injecting them blindly with no ultrasound, they have no idea where they're going. And you know, the the clinic you explained is the clinic that was doing all of those things. They had a nurse practitioner that was overseen by a retired cardiothoracic surgeon to do joint injections blind, no no ultrasound, with you know, a vial, they didn't draw any blood. They did call it PRP, but they didn't draw any blood, so I was very confused about that. And and PRP and stem cells is what they advertised, and so it's just it's such a and good news, their clinic is shut down when I drive past it. So that's good news for me. I think they've actually shut down, rebranded, and popped up somewhere else because I keep hearing about this. But you know, is do we want to believe the bus that you know the poor uh salesmen are just told what to say and they don't actually know what they're talking about? And so everybody's kind of like misinformed in the supply chain, and and there's just a few bad actors at the top, or do you think it's more concerning than that?

SPEAKER_00 41:54

I don't know. I I like to believe the former. I mean, that's what I like to think. And I know some people who started using these. In fact, I know a guy whose daughter was a rep for one of these companies, and he was trying to get me to start to use them, right? And he thought it was an orthopedics fine guy. And you know, I never got a Christmas card after that because I I didn't to use them. But, you know, I I think that we want to think the best. And I and I think that if you're given a white paper, right, and you read this about the cells and you think, oh, and then you have a colleague who's doing it, you'll probably feel comfortable doing it and start doing it without a deep dive. And really, we started doing it. And and then once we realized we weren't getting the results after six months or so, and then we did a deep dive, right? But this was before there was there was multiple studies out there that showed no living cells after Thaw on the on this group of products. So I don't know, I don't know, Ariana. It's a it's a good question.

SPEAKER_02 42:49

Yeah, yeah. So ultimately, you know, what is that next step, right? How do you be successful? How do you juggle all these things? Like, oh no, no, what is what should I do? How should I do it? Should I do perinatal? Should I do birth products? Should I just stick with PRP? Because you know, is M fat kind of you know risky? Is it not risky? What about BMC? Is relying on elderly people's cellular and platelet health maybe a hard pill to swallow for some of us who don't have that, you know, warm, fuzzy feeling that oh yes, everybody's cells work great. Shoot, you know, we know diabetics cellular health is terrible. Um, and we maybe shouldn't be considering uh biologic and and metabolic optimization before we even step foot in that consideration of in injecting, I don't care what you inject, if if the host is not well, it I really think that that is a another consideration, right? And so as we open and are pushing towards a thriving orthobiologic practice or considering opening this micropractice, a service line within your current practice, we have our orthobiologic practice launch system, you know, that orthobi that orthobiologic and injectable knowledge base that we just went over, we had talk about how we attract the right patients, how to create a cash-based business, because guess what? We didn't learn it in school, how to have high-converting consultations or goal-directed consultations, and how to be successful. Money is inherently not bad. So if you want to know where to, if you want the fast track, I would just offer you your a little QR code. It's a tiny little quiz to say what your next best step is. If you want the uh deep dive, we are now holding a three-day uh predictable cash pay practice workshop. It is only limited to 40 physicians, Scottsville, Arizona, and we do so much with MSK Ultrasound, AI practice tool implementation to save you time, effort, money, a cash pay revenue infrastructure, and it's a private, uh personalized implementation environment. So this is a workshop style environment. We did just extend our um early bird prices till April 1st. Date's June 5th through the 7th. So please write this down. If you want to check out the full uh guide uh guide of what we're doing, it's gonna be truemd.institute backslash arizona. So I'm gonna just wrap this up. Thank you so much, Kristen. We're gonna turn it over to the QA. There's not too much craziness, there's a there's a little going back and forth, a little passion, if you will. So there is some questions. Um, you know, is PRP BMAC FDA approved, right? And we I think we talked about this. Um if you'd like to share your thoughts, I get these questions all the time.

SPEAKER_00 46:26

Yes, the they are both FDA approved. They're they both have 510Ks for orthopedic applications. The caveat, like I said earlier, and you can disagree, Ariana, if you think I'm wrong. I mean, this is a discussion, is that it's it's approved for intraoperative orthopedic use. So the question is if you're doing it in your office, that's really not interoperative. So it there because thereby becomes off label. But most you you could check with the manufacturer that you're dealing with, but the majority of the manufacturers out there have 510Ks, but it certainly doesn't hurt for you to do your homework and make sure that manufacturer has a 510K for the device, right, with the FDA.

SPEAKER_02 47:02

Yeah, so this was a great question. My understanding of off-label means that there has to be an approved FDA indication to have an on-label use. And you are exactly right. So the on-label use for PRP is for the improved handling of bone graft within surgery. That is the on-label application for PRP. So if you are not using it that way, which like 100% of us are not using it that way, then you're using it off label. But that is correct. My favorite like way to think about this is heroin is a drug, it does not have FDA approval, therefore, you cannot use it off label because there's no on-label indication for heroin, although it does exist and is for sale for enterprising young people. So that's uh that's a I think it's a good benchmark because there's now you know there's peptides and like just because it exists in the market doesn't mean that there has been an FD indication and it or has gone through FDA trials or any of these things, it just exists in the black market, um, or the gray market, if you will. So, yeah, absolutely. Let's see here. There's a question. There are practitioners actively marketing Wharton's jelly stem cell treatments administered via IV and nebulizers. Your thoughts, Kristen?

SPEAKER_00 48:32

No, you know, anything FDA or nebula, I mean anything FDA, anything IV or nebulized is so off, you know, it's non-homologous, it is so not FDA okay. And, you know, there have been multiple clinics that have been shut down for that. And really, I mean, where's your indication of its efficacy for that application and risk, right? I I I, you know, the and there are a lot of clinics offshore doing this, and some of them have great results, but it's a it's a whole different to me what they're doing in Panama uh or wherever, it's a it's a different thing than what we can do here.

SPEAKER_02 49:10

Yeah, it absolutely is. You know, I was talking to one of the founders of Vet STEM. So Vet STEM has been in business, it's a veterinary, culture expanded cell company. It's been in come it's been in the veterinary world for 25 years plus. They now have a human branch called personalized stem cell. Um, and so I was talking to Bob Harman, who has been doing, you know, the vet stem forever and ever, and their protocol is intra-articular injection of the culture expanded, adipose-derived, culture expanded MSCs, as well as IV. But when I asked him when you're placing things IV, what you know, what about that like first pass? What about the load through the lungs? And like, what is your thoughts on uh that issue? And he was like, Oh, well, I haven't really thought about that. I was like, oh man, okay, I'm not sure. Like, I've been presented opportunities for Ivy stem cell infusions, and I just get a I get I think we don't have all the information about what happens to those cells, where do they go? You know, maybe if you're treating for lung-based issues, maybe it's brilliant, right?

SPEAKER_00 50:32

Um yeah, the idea of like think about COVID and the you know what what PRP can do to a cytokine storm and you know, or even cells, stem cells. I mean, gosh, what a brilliant idea, right? But it's just not, it's like to me, so far off the reservoir or reservoir, no. Reservation, sorry. I live by a reservoir, I've got reservoir in my mind, and it's so far off the reservation that I just am like, but then again, patients are desperate, right? You have COPD, you have Parkinson's disease, you have ALS, you know, and you don't have 50,000 up 25 to 50,000 dollars to go offshore.

SPEAKER_02 51:10

Yeah, you know, yeah, I know, I know. Yeah, and you know, the FDA is not without the the other part of this, which is it takes millions and millions and millions of dollars and 10 to 12 years of product development to even get pushed through.

SPEAKER_01 51:28

Right.

SPEAKER_02 51:28

And I'm sure, you know, as always, you know, if you're wondering about why things are weird, check the money, right? So I'm sure there's there's plenty of that issue as well. So yeah, I don't think this is a solved problem, but I do think that the the physicians, the onus is on the physician to be educated about what the FDA understand is, what the state rules of the manufacturer, as well as uh the practitioner rules, as far as it it comes around, you know, viability, post-thaw viability testing, which you know, I think in one of these um conversations was like, okay, you know, there's X hundred million, but don't they come frozen to your clinic? So how are they able to show post thaw viability? I'm I'm I don't know that answer, and maybe I need to delve into that has to be, I think, done.

SPEAKER_00 52:30

I think they have to, it's a good question. Like, do they take a batch and do a post-thaw viability on a batch at the manufacturer's and then send the rich rest of the batch off? Because remember, you get a lot of product from one placenta. So I don't know exactly how they do that, but obviously they're not in your office doing CFUs, right? So they're not culturing them right there in the office. So I'm not sure how they do that. And I can't believe with the plethora of clinics that are out there actually using this product that the manufacturers are actually providing. That's the question, you know.

SPEAKER_02 53:02

I mean, if anyone's on this call and and and has insight on, you know, do you get you know post-haw viability? They they, you know, on the conversation on the chat, it says yes, they must provide to the patient a lot, uh, and each lot must be yeah, assuming that they are frozen and thawed by botch. So, no kidding, you're you're absolutely true. I I think that what they are supposed to do and what reality may be happening is maybe two different flavors.

SPEAKER_00 53:35

Yeah, because you think that if there was that much data that they had, I mean, these there's a lot of product, these manufacturers have money. Like, I don't understand why they haven't done a study. You know what I mean? Like, if I am this company and I have this much, I mean, there's like the one that's right now trying to get an IND with the FDA, they're obviously gonna have to do studies that show the viability. So I don't know. It'll be interesting.

SPEAKER_02 53:56

Yeah. Well, I'm going to Columbia to Medellin next week. So maybe I'll report back after my uh see and how the secret sauce is made.

SPEAKER_00 54:04

Yeah, it's pretty interesting there. I I like I said yesterday, I was supposed to go last year and had to cancel, but I think that uh it's it's a great clinic. I think they do good things. It's it's it's gonna be interesting to see that whole other side, right?

SPEAKER_02 54:16

Yeah, that does not exist in the US currently. Exactly. Well, again, everybody, thank you so much for joining. If you're interested, go ahead and just log on to the true mdinstitute dot institute backslash arizona. And if you didn't take the quiz on how the heck uh how ready you are to add ortho biologics to your clinic, please take the quiz and then uh we'll see you in two weeks for conversations in region. I have a treat for you all, it's gonna be a St. Paddy's Day treat with Dr. John Kanab. So everybody stay tuned, come back next uh in two weeks, and we will see you there. Thanks so much, everybody.