Regenerative Medicine: A Look At Transparency In Healthcare | Conversations in Regen Episode 8

You’re Not Getting the Full Story in Regenerative Medicine: A Look at Transparency in Healthcare

Transparency Is Medicine’s Next Revolution – 🌐Visit my Website https://pxl.to/AD/tq8nuql

What aren’t patients being told about stem cell therapies? Are clinics offering orthobiologic treatments giving the full picture—or just part of it? And how can physicians responsibly navigate the murky global market of regenerative medicine: a look at transparency in healthcare?

In this episode of Conversations in Regenerative Medicine, I sit down with Dr. Rikin Patel, a thought leader in regenerative orthopedics and interventional orthobiologics. We dive into the evolving landscape of regenerative medicine, from autologous therapy and orthobiologics injections to allogeneic cell therapies and culture expanded stem cells being used in patient-funded clinical trials abroad. With patient transparency under scrutiny, this conversation brings clarity to what’s happening outside U.S. borders and what ethical considerations physicians must confront at home.

You’ll hear first-hand insight into the development and regulation of regenerative medicine in orthopedics—especially in relation to regenerative orthopedics and sports medicine. We cover hot-button topics like platelet rich plasma therapy (PRP), transparency in healthcare practices, the future of orthobiologic treatments, and how orthobiologics course knowledge can empower clinicians to offer better care. This episode unpacks the role of state laws, FDA oversight, and patient-funded research, all while spotlighting real-world scenarios doctors face in explaining orthobiologics to skeptical or overwhelmed patients.

If you’ve ever wondered whether it’s ethical—or even safe—for patients to travel abroad for stem cell treatments, or how to responsibly counsel your own patients on regenerative options, this discussion is for you. Dr. Patel shares his experience leading over 85 patients through a clinical trial in The Bahamas using up to 200 million allogeneic MSCs, while openly discussing the limitations, safety data, and consent protocols required. We also unpack how physicians can use systems and education—not “sales tactics”—to ethically introduce these options in cash-based models.

By the end of this episode, you’ll understand the importance of marrying regenerative medicine innovation with patient transparency—and why autologous therapy and orthobiologics still play a critical role as the field expands.

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 

_______________________________________________________

Follow us and subscribe to our links below ⏬⏬⏬

Website: businessoforthobiologics.com
Apple Podcast: apple.co/3Azvt3R
Spotify: spoti.fi/3oICYmh
Youtube: bit.ly/drariana

Transcript

Copy Transcript Copied

SPEAKER_00 0:00

We have done 85 plus patients in their MSK trial, combining IV and local joint injections with up to 200 million allergenic bone marrow derived stem cells.

SPEAKER_01 0:11

I do believe that this is the vehicle for change and for freedom from the current medical insurance-driven system.

SPEAKER_00 0:21

You cannot be successful in orthobiologics without a process. So I don't think it's something to fear. I think we need to embrace all the options that we now have that are coming our way.

SPEAKER_01 0:32

So my belief is that orthobiologic treatments will be first-line treatment for musculosched care in the next five years. Thanks everybody for being here. This is Conversations in Regenerative Medicine, and we are exploring cutting-edge insights, and the we're shaping the future of interventional orthobiologics. So very exciting. I am so pleased to have Dr. Rigan Patel. He is absolutely a noteworthy figure in interventional orthobiologics and spine care and really thought leader in the field. And Rigan, I want you to kind of give your what you are up to. And I know you're obviously uh serving Toby in uh some capacity for quite some time. And tell me what you're up to.

SPEAKER_00 1:40

Yeah, thanks so much for having me. It's great to be here. And you know, appreciate the accolades, but you know, amazing to see all the things that you're up to too, and really giving it back, giving back to everyone, kind of bringing people forward who are interested in learning from others. I think that's the most we can do with our experience is sort of give back. And yeah, so well, I'm currently actually practicing in New Jersey, and that's after spending a year traveling and all over the sort of the country and practicing in different practices and doing a lot of the spine work that I do, but working at a large multi-specialty group called Summit Health. And it's been interesting, it's been nice to kind of be welcomed with my regenerative sort of understandings and experience, and look, they're really looking to expand PRP and we're starting with Bone Marrow concentrate at a post and you know, seeing all these excellent groups, large groups and orthopedic groups now kind of wanting to establish centers of excellence. So it's been fun. That's kind of where I thrive in sort of building things out. And then, yeah, like it's been a good almost just over a year, where kind of took that big step into allogenic MSCs and then looking at where we are headed with that. And you know, I was kind of afraid as well in the beginning to kind of even talk about it because I felt like it was so, you know, it was so like with all of us doing autologists for long, it was like it was black sheep type material, like you're doing allogenic work. And kind of was just it was an interesting sort of roundabout way that landed with Cell Colabs Clinical in the Bahamas, and they are running a open label patient-funded, which we can get into clinical trial, a phase one A2. And they met myself, Dr. Samson, through Brian Johnson, who you might have heard of, who's pretty big in the longevity space, and he's talked about it and been pretty open about his stem cell journey. So got the opportunity to become PI on that clinical trial. And here we are. A year later, we have done 85 plus patients in their MSK trial, combining IV and local joint injections with up to 200 million allergenic bone marrow derived stem cells. So super cool. And you know, they call them mesenchymal stromal cells. We don't call them stem cells, and they have a product called stromophort. Um, that product actually comes from 20 plus years of research from Katarina LeBlanc and the Karolinska Institute, you know, and you learn very quickly how some of these cell scientists 20 years ago, like you know, Dr. Kaplan and Dr. LeBlanc and some others really sort of pioneered all these the ideas around the ability of MSCs. And so there's a lot of research behind them in the allogenic world, and now we have this opportunity to kind of start applying them. And that's been super exciting. And yeah, to be clear, I don't do any allogenic work in the United States. You know, my good friend Scott Bruder looks after me in that sense and he kind of watches over me and says, What are you doing? And just to be clear, nothing allogenic in the United States, but excited to kind of be able to travel international and see what other countries have been up to. So that's where I'm at.

SPEAKER_01 4:47

That is amazing. And yeah, this is exactly why I wanted to hear more because I was like, hold the phone, allogenic, allogenaic. Like that what tell me more. I thought that was, you know, not a thing. And but yes, it is absolutely a thing, and it has been a thing for a while with some really good research behind it. So let's absolutely dive in. For those of you who don't know me, I'm Ariana Demurs. I am a recovering orthopedic surgeon and educator and trainer in orthobiologics and in ultrasound. Don't miss out. Please subscribe to our newsletter now to stay ahead of the world of orthobiologics. You can find the link below. Additionally, if you're ready to start this journey with me in my orthobiologics masterclass, come join us. And I'm passionate about helping physicians find a way to integrate orthobiologics into their practice seamlessly. I do believe that this is the vehicle for change and for freedom from the current medical insurance-driven system. So it is a passion of mine, and this is why I do this. And so thanks so much for joining me. This is gonna be, you know, more of a fireside chat, if you will. And hopefully we'll get some actionable insights and things that maybe we can talk to our patients about because all of our patients are asking these questions, like, well, well, shouldn't I just go to Panama? Shouldn't I just go to wherever? And so I hope that we can gain some insight on what's actually happening outside of the US and how do we counsel our patients for that? So, my belief is that orthobiologic treatments will be first-lane treatment for musculoskeletal care in the next five years. I think cortisone will and should go away. And if and only if you fail these orthobiologic treatments, should you be a candidate for surgical intervention? And honestly, the train is leaving the station. If you're not actively doing this, you gotta get on the train. So it's leaving with or without you. Please get on the train.

SPEAKER_00 7:06

You know, in three to five years, this is gonna be frontline treatment. And it's kind of why it's worth it because we cannot leave this, you know, this space with cortisone as being the only option. And we've just kind of hidden from this, we've hidden and not addressed the side effects of that and the lack of data around it and just put up with it, you know.

SPEAKER_01 7:24

Ah, it drives me nuts. Like, if you know, when I tell patients the side effects, they're like, What? No one's ever told me that. I'm like, yeah, we were remiss and we did not appropriately counsel patients the actual risks of cortisone. And so hopefully we will do an expose on the risks of cortisone and hopefully we can kind of give them a better option. And when I think when we neglect to offer all of the treatments out there, really, you know, that is in part maybe a little bit unethical to only offer those things that are covered by insurance, and we're neglecting to offer the whole other piece just because of an insurance coverage piece. So it's driving me crazy, but you know, I'm doing my best.

SPEAKER_00 8:17

But I think that you know, we a lot of people ask, and I was on a call with some colleagues at least and like, like, I don't know how to bring it up, right? And you know, I know you're working hard on teaching doctors, and I've had a lot of conversations as well with like how they have to approach it, but patients appreciate that you laid out all the options, whether or not they go for it or not, they can't make that financial decision. That fact that you included them in all the options and they get to choose and they make a choice for themselves. You know, I'm not I don't love using cortisone, but there's moments where that's all the patient can have and do, but they've gone through the whole conversation on what the options are and they choose it. Their body, their choice, you know, and I think that happens. But when you don't when they don't know about it, I think what we're doing essentially in having that conversation is raising the awareness to each person, who then raises that awareness to the person, you know, in their own community. So that's how you kind of get to where your goal is, where you're not doing it.

SPEAKER_01 9:13

Right. Yeah, and you know, people ask me all the time, they're like, Yeah, you know, it this is hard. We didn't learn this in medical school. You know, maybe we've tried some things, maybe we didn't know the science behind it. That's for sure. When I started, I had no idea. I thought you drew blood, it went in this little black box, something happened, and then poof, out on the other side, magic PRP showed up. We all know that's not true, but we're not being taught this in our training. And, you know, these techniques, the use of ultrasound has massively changed how good we can do this. And so blind injections are really not where the field is currently at. And then finally, you know, that cash business, marketing sales, I think doctors are kind of panicked about it. They're like, oh, I didn't go to marketing school. Yeah, none of us did. But let's talk about this. We sell our patients every day on the things that are right for them, the things that are the best options for them. We tell them the risks and benefits of taking a antihypertensive or not. We tell them about what might be the best option for their health and why they should consider option X over option Y, why smoking is not a good plan for them and what their, you know, other things. So we're doing this. My sales and marketing department is my education and guidance department. And that's what we know how to do, and that is in our wheelhouse. And so it's not some, you know, used car salesman. This is education and guidance to help our patients understand what the best options are. So here's the question: how do we win at this game, right? And while we're talking about the science today, we also need to consider how we talk about this with our patients so we all win. So we all have the opportunity to offer the these treatments that are in our best in our patients' best interest. So obviously, you know need a system, right? We're not gonna go over all of this today, but you know, we're gonna get you a little bit further down this journey on how to be wily successful in your orthobiologic practice. And so you need a system. And with that, we're gonna start with our orthobiologics knowledge. So, Rickon, let's get down to business. We have some questions. So, the first question, based on your expertise and leading the field in this allogenaic stromal cell world, is the use of these culture expanded cells pushing the boundaries of science? Or, you know, is this crossing that ethical and regulatory lines too early? Or is this prime time? Like it's about darn time.

SPEAKER_00 12:07

Well, it's a great question. And I really would say that we absolutely are pushing boundaries, okay? Like a little bit. There's a lot of science, and I don't think it's too soon. I think it depends on where you are in terms of these lines. And unfortunately, you know, I do feel, and a part of the journey for me, and similar to you, is this came from a lot of patients asking questions like, well, I heard I can get stem cells in Mexico. I heard I can go to Panama, I heard I can go to Costa Rica, I could go to Dubai. And, you know, all of a sudden, we're not well educated on those options and what they're pursuing because we're only doing certain things in the United States. And as I dove into this, there's something that's really clear, and that is if your cells are manufactured from a very strict process that fits the guidelines and is compliant with GTP good tissue practice and GMP good manufacturing process, we're not really pushing the boundaries of science because we have demonstrated that MSCs, IV, and you know, injection-based are safe, and there's a lot of studies that show that. But similar to autologous therapies, we're not able to make a lot of treatment claims because we're still in the discovery of what actually works and what doesn't work, but we know it's safe. And then you come into the United States, and I completely understand that you know there's the 351 pathway, and all these things require drug approval. So, to some extent, we could be crossing a regulatory boundary. Ethically, it's extremely difficult because in some cases we might find that this, like you mentioned, is the best option for the patient, but it's not in our arsenal. So I think what we have to be careful of is that we only think about that all the time. Um, and obviously, like my most important thing is my medical license. So I also think about that a lot and what I'm willing to do and not do within the United States. And it's hence why I was willing to travel outside the borders. And I felt, and in collaborating with some of my colleagues who you know, you know, Dr. Samson, Dr. Rowan Paul, and Dr. Alfiero, like we really felt that it behooved us to create a pathway where physicians who wanted to make sure that their patients received, you know, ethical, scientifically credible, and trustable treatments had an option where they weren't going to countries where, as you know, like a lot depends, an outcome depends on a lot. It doesn't just depend on, it depends on quality cells, right? Like a quality biologic or a precise biologic. It depends on a good diagnosis, so precision diagnosis and delivery, like ultrasound and floro. And I think those type of skills, I will say that physicians in the United States are probably the highest trained level that I've seen, you know, and we're treaching the globe and we're learning back from the globe, but we had to find a way because we have to work harder to bring this science to the United States. And there's a lot of countries that are ahead of us already, and you know, that should not be the case. And so, how can we do that in a way that also allows us to collaborate? Is what I think we're kind of in this sort of circle of right now.

SPEAKER_01 15:17

Yeah, absolutely. Well, you know, we still have more questions. So, should clinics offering the allogenetic therapies be required to disclose the the, you know, the long-term safety data? And this, I think, not only goes to allogenic, but uh, you know, autologists as well, as prominently as maybe the promotion of the potential benefits, right? And I've asked this question a lot is like, who should we be policing ourselves? Should we keep it, you know, should we be collaborating with other clinics? You know, how do we clearly, and I think this goes for everybody who's in this autologous and allogenaic field, like, how do you disclose the data or not that much is out there data while still helping to guide the patient that you do think it's a beneficial option?

SPEAKER_00 16:20

Yeah, I think you I think collaboration right now is key, and you have your sort of people that you trust in your kind of circle of collaborators, and you allow the patient to understand. Like, my goal really is to allow physicians to have that conversation of taking them through understanding autologous and allogenic. And I go through that, right? And with a lot of patients, and there are patients that I see that want the allergenic cells, and I'm like, you really just need an autologous. Like, frankly, I don't need to send you to the Bahamas to treat a tennis elbow with 50 mil and allogenic bone marrow derived stem cells, right? But they want it, but they don't need it. Yeah, right. PRP or PRP bone marrow combo, autologist is plenty likely to take care of that. And so I you mentioned it so importantly, and I think it's so important to ethically have that conversation because it's fundamental and foundational to inform consent, right? For someone to understand potential benefits, known risks, and the unknowns, right? So, and making sure I think the biggest thing is that clinics align their marketing and consent materials correctly, okay. And the safety data, yes, I believe there's a lot of strong safety data, especially around bone marrow derived allergenic cells, like the bone marrow literature, way ahead of adipost and umbilical, although there's a lot of good data and systematic reviews on that as well. But I would look at, let's say, Ariana, you know, I have someone who failed PRP or did fail PRP bone marrow a little bit and had less than a year relief, and now like I gotta do this again. You know, I see that people have already tried PRP and they're on to the next thing, and they have severe DJ D and they don't want to have a knee replacement. Maybe that's where you have that conversation. Well, you know, I think that there is an option around getting a stronger dose. And finally, I feel like what, 15 years later, we all are like gotta be above 5 billion platelets, and ideally eight to 10, like consensus, right? And my thought is dose is gonna matter on MSCs as well. And so that's gonna be a hard thing to replicate autologous and be predictable. It's much harder, and I think allogenic plays a role. And you could say, look, here's the things that I would look for if you want to go do this place. You got to really understand where your cells are manufactured, who made this product, because all stem cells are not created equally, okay. Secondarily, like, okay, how what is the actual reconstitution and thawing process of these cells, and how do they check for cell viability and sterility, you know, at the time of procedure? Because a lot of cells get shipped in a lot of sketchy ways, and we know that when they're they don't last, okay. In fact, in the Bahamas, when they reconstitute our cells in the hospital, they check them under a microscope for viability, they make sure that they have the right count that they say they're gonna do within like 99% accuracy, and then we have about a 90-minute window to deliver these cells because not that they're gonna all die, but you know, they get less optimal over time. And finally, the scariest thing I've seen, and I've visited clinics in Mexico and other places, and I don't think it's necessarily intentional, but the idea around procedural processes that are sterile and you know the best for the patient and low minimizing risk, those protocols and SOPs are not always in place. And so I think those are the questions I always ask patients, and then who's gonna follow up with you? Like our clinical trial has 12-month follow-up to look for adverse events, you know, serious adverse events, and look at efficacy. And if you're dealing with the doctors who did the procedure, you go to some of these other clinics, you're like injected and gone, and nobody's there. So I think those are the things that come along with this, and when we be careful about promoting its benefits, and I don't, we don't have any treatment claims, we make none. You know, we know we're still we're looking at the safety and we're looking to see what the functional pain improvements are, and and you know, also some imaging results. And there's a study that's a sister sort of a study going on in in Dubai, which did an excellent job looking at 12 patients and did pre- and post MRIs at six months as well to look for changes. So there's a lot of cool stuff happening, but I feel like sometimes the ones that you're marketed, you know, market at you may not be really the best ones for you.

SPEAKER_01 20:34

Yeah. Now walk me through. So this is because you're talking a little bit about dose, you're talking a little bit about, you know, reconstitution and viability, and we all know that's important. And so when I'm trying to kind of understand because I what I know about the allergenic is from the vet world, you know, the vet data. And that was there was some hurdles about uh sensitizing the equine patient. And so does that happen in the human patients? Do you what is what's what happens with that? You know, because it's an allergenic product, is there the risk of sensitization? Don't miss out. Please subscribe to our newsletter now to stay ahead of the world of orthobiologics. And you can find the link below. Additionally, if you're ready to start this journey with me in my orthobiologics masterclass, come join us.

SPEAKER_00 21:37

So if you're meaning by sort of like sensitization, like are the cells immune privileged? Is that what you're saying? Or are you saying that over time you can't apply repeated doses?

SPEAKER_01 21:48

Yeah, I think more that because that was that's my knowledge base from the VAT literature is that the first one was great, the second one not so good because of the sensitization.

unknown 21:59

Right.

SPEAKER_00 21:59

So So that is an area that I don't know that we have a clear understanding on yet. We have, at least to my knowledge, we are not at a place where people are getting multiple repeat doses. And so that would be interesting, definitely important to follow out. So does it become, you know, less effective, right? Do you need a stronger dose? You know, do you need it's like, hey, you do this once, right? But you need two treatments in a year, and then we see your results in as long as you get is what you get, you know. So I think those are questions that still remain somewhat unanswered. But you know, I do know that pretty much the literature is clear that well sort of manufactured cells are immune-privileged and non-tumorogenic. Like those are the things that people use to scare people very quickly, and that's just not the case with current data. And the last thing I point to a little bit, which is interesting, is you know, we do now have an FDA product approved in the United States using IV MSCs, and that's the mesoblast product that is designed for graph versus host disease, right? And it's a really big step. I think people underestimate how important this is. We're acknowledging that these cells treat a disease, right? They've isolated it to a specific disease, and they're safe to be administered IV. And what's interesting around IV MSCs is they're not really going to make multiple different drugs yet on MSCs. The MSCs are gonna just be delivered for, you know, can be delivered for different conditions. So it'll be interesting to see how that sort of gets expanded because we've kind of checked the box on safety.

SPEAKER_01 23:37

Yeah, absolutely. Well, shockingly, we have more questions. So, how do we reconcile that promise of culture expanded cells? And how do we like where are we on this bringing this to the United States, right? Because we know it's more than minimally manipulated. And then, you know, when you now look at these new laws in Florida, that there are doctors thinking that now it's completely legal to be using alginaic birth product-based stem cells in the United States. How do you rectify that? How do you how are what's your thought process on where we stand on that?

SPEAKER_00 24:23

I would say that time is gonna allow that to really flush itself out because we're at a very interesting crossroads where access is going to increase substantially. My concerns here are that a lot of doctors won't really deeply dive into that state law that's been created and follow all the guidelines, so they'll ultimately be putting patients at risk. We'll see a lot of false claims. And then I'm like, who's gonna police this, right? At the state level. So I think that's the key. And I think Florida, I will say I somewhat applaud an initiative because some of it's very, you know, well thought out. And there's other parts that I think that have some gaps and lack clarification, but the initiative, you know, is to try to allow some of these treatments that fit certain strict criteria, which I'm concerned is not going to get followed.

SPEAKER_01 25:15

Yeah.

SPEAKER_00 25:16

And there's this whole other piece, like, and this has been clearly stated by multiple people smarter than I is that look, you can follow every state law to the T, but you do not that doesn't override the FDA oversight that they have over this. And then the fact that it still needs an IND and a BLA requirement for non-exempt products, and they kind of the FDA still has the ability to supersede that. So, how do you navigate that space as a physician? Um, yeah, I I think you have to one, I would, you know, do not practice outside your specialty. I mean, it's clear in the guidelines, that's an area. And that's where I think the biggest concerns for me have always been. I generally find doctors who are educating themselves on autologous, taking their time with it, they might be the better ones to eventually adopt some of this. And I'd love to see some flexibility around, well, if there's if we are collecting data, right? And we are collecting adverse events and we're reporting it and it's open registry type stuff where, hey, look, I'm recording everything. You know, is there some room and can you maybe start something? And I'm not here to decide what you ultimately decide to do, but I would say make sure if you are gonna do it, you really pick your manufacturer correctly. Because at the end of the day, if you don't have that reliable source, you are definitely taking a risk for most importantly your patients, and that's my concern. Stem cell, you know, good stromal cells or stem cells are not inexpensive and they are being sold that way. And that's a big concern for me as we enter into this space with Florida, and there's other states like Utah who've passed laws, and I hear there's more coming down the pipe, and you know, and that's kind of for me. I believe that we as physicians, and you went back and you mentioned this, like collaborating and sort of, you know, we have to raise the awareness to educate patients on how to make the right choices as they look for if they are going to go down this route because they don't know these things, and often it's very much hidden from them.

SPEAKER_01 27:15

Well, yeah, and I mean, I was in Florida, you know, yesterday or the day before, and I was talking to doctors, and they all were under the impression that it was fully legal. I was like, whoa, whoa, let's hold off and like be very clear with all of the nuances of this, of these laws, like GMP manufacturing and sourcing and FDA oversight for all of these things, still. Yeah. So shockingly enough, we still have more questions. Yes, but I'm so glad that you brought all of that up. And so the last one that I wonder about is, you know, are patients becoming guinea pigs for these unregulated global stem cell market, not the 1A2 trials, right? That you're running, but across the globe, you know, you can fly anywhere and get anything. And what I always worry about, you know, is if we stay silent about this, like who's collecting data? Why can I not find a darn thing on any of these, you know, clinics? And what's what is our responsibility as you know, a leader in the field? What how do you reconcile that as your thoughts for your piece of the puzzle on the global market?

SPEAKER_00 28:38

Yeah, what I recognize a little bit is a lot of things are outside of our control.

SPEAKER_01 28:44

Yes.

SPEAKER_00 28:46

Had to like learn that certain things we just have to let be. And I'm not saying that we don't advocate. I think part of my desire, I never thought I'd be a researcher or working on trials and things, but at the end of the day, the more we can work to not make it look like the black market and bring it into awareness and work harder to collect data and work together to show that it's effective and allow it to be sort of talked about openly and not people searching and educate patients on again. I think that's the only way is educating the consumer to a point where they know how to make a good choice. And I think it's hard. Some countries are doing a very good job, like you know, UAE is doing a really good job trying to like create regulations, guidelines. You know, other countries are just kind of turning an ear. I've seen good things in Mexico, I've seen some really scary things in Mexico, and it depends on where you go. But I think there's only really a handful of really good cell manufacturers, and so that's the other concern. And I think you and I both know that if you get a well-manufactured stem cell, you should may not have an outcome. Okay, you might have an outcome, but you should not have a complication, and that's the part that concerns me the most. But I don't know that we're at a place anymore that we can really prevent patients from becoming guinea pegs, as you mentioned. I think it's happening, and it's not just happening in ortho biologics, the longevity space is just like, you know, that part, you know, and it's wild, you know. We are so restricted as physicians to say certain things in social media, okay. But if you're not a doctor, you could influence anybody to get just about anything, okay, and talk about unproven and unregulated things out there, you know, it's a tough place. So I think that the that side of sort of if you want to call it social media or information media has really shifted. I think the best thing we can do is not be afraid, because I have not been great at this, but working hard is to put our voices out to kind of just speak our truths, you know, come from where people can look at us as trustable sources of information. That's how I like to position myself. I don't need someone to come treat with me anymore. Like, that's not like that, it's probably an old sort of habit. We're like, oh, I want to take care of everything. No, like I think we need to be the influencers of health and guide for someone to look for and achieve a result that they're looking for, whether it's with me, you, or someone else we know, or someone who I trust in Spain, that's the most important thing is that they find that person and they're able to work with that person to get what they deserve, which is a safe, you know, compliant, ethical treatment on their body. And so I think that's how we do that. And a way I think we need to do that better is we all need to sort of collaborate a little bit with connecting patients to the right people in the right places. That's the most important piece.

SPEAKER_01 31:45

Yeah, that's so great. You know, the last piece that you bring up is, you know, this clinic that you are a part of, you talked about the trial and the fact that it's self-funded or patient-funded, right? And whenever we're doing research, there's always that critical piece like, should we be allowing patient-funded trials? Should we not? Should who's gonna pay for it? Like this has been a really big thorn in my side as we try to do a really good job at doing research and moving the needle forward. There's a lot of, you know, naysayers that say that, you know, if you're doing patient-funded trials, that's not a real trial. And I personally don't think that's correct. But what do we say? You know, what how do we kind of address that issue?

SPEAKER_00 32:40

For me, and I you bring up a really good point. Like, do I believe a patient-funded trial is going to get a drug approval? No. Like, that's we need to go, we need to take the patient-funded trial and that data and construct a better trial around safety and efficacy. What is our primary endpoints? What condition are we kind of honing down on to that we're seeing the best results? So I think it's it allows us to be a little bit of a more innovative incubation area to kind of say, hey, this person has a shoulder issue and a hip issue, and they want them injected, and we can inject them. We can follow them, make sure they had no adverse events. We can look at early data and say, well, what was that outcome? What was the knee versus the hip versus the shoulder? What are we seeing? And that's some of the stuff that I'll be presenting, you know, at Toby this year is what we're seeing out of these things, but it's to really give us the opportunity to learn. And the Bahamas has created a full national stem cell ethics committee that we report to. We are running a clinical grade trial in terms of follow-up and trust me, paperwork as a PI, but it's the entry point, and that's what I think it allows us so that we can find a way, a better way, to democratize this in the future and run better trials off of it. Because, you know, and I do think this will be a big place because when you're going for drug approvals in the future, you know, those the reason PRP took so long, I think you know this is going to fund the PRP trial, right? So we've seen great outcomes, but to get it covered, we're gonna struggle. Is my perspective, and one of the things that I think is important is I don't think we need to all run to jump in to start doing allogenics, but I think we need to be aware. I think we have worked a lot of people have worked very hard, way harder than me. I've kind of been riding the wave a little bit to get PRP and some autologous procedures sort of to the forefront. And this is gonna happen quickly, it's gonna happen much faster than PRP. But I think we could both agree that we still don't have head-to-head data on autologous versus allergenic. So we have work to do still and to figure out you know what's gonna happen. And my sort of thought on this whole thing is that as we narrow more and more into precision medicine and we collect more registry data, and that we will basically be able to differentiate who should get what and even potentially from what cell source for the specific problem. And that would be a really great way to be able to approach patients in the future for orthopedics.

SPEAKER_01 35:14

Absolutely. Absolutely, you know, and I do think that's the next piece is that precision medicine piece and to be knowing exactly what, you know, treating the patient in front of you and instead of, you know, this one size fits all. I think it's gonna be much more precise and it's gonna be much more whole body, whole person. It's not gonna just be the cells, it's gonna be the optimization, it's gonna be all of those pieces. So I think absolutely that's so perfect. So then the question is what is the next step? And this is what we're gonna say, you know, when we're bringing this all home, obviously we cannot use any of these Kouldri-expanded cells. But what we can do is apply what we know and what we know is the next step in the field, and then bring that home and say, okay, knowing that there is this thing out there that exists, what's the next step? And how do I go from PRP to this, right? How do I even know this? And so, you know, you need the practice learn system, right? You need to know the orthobiologic knowledge first. You cannot go forward without knowing that. And then you need to be able to serve the right patients, right? The a lot of a book on the litus uh doesn't need allogenic, you know, culture expanded cells. So I think that we've proven that for the last 15 years. That's something that we can treat very reliably with PRP. And then those very small subsets that fail, I think BMC has been shown to be perfect appropriate treatment. So what we now know is that cash-based business is how we do these things. This is how we get those products to our patients. And some of us are doing trials in our office right now, right? And that this is how we move the needle forward. This is how we tell the our patients what to expect and be able to make sure that we are setting those expectations and being able to tell the patient what they can actually expect. And so this isn't a sales job, this is education and guidance. And then really to be able to provide high-quality treatments for our patients and put it all together to not only have success for our patients, but also for us. Being able to step outside that insurance-driven care and actually be able to care for patients with all of the things that they need. I'm sure for you and I know for me, has been just so rewarding. It's been fantastic.

SPEAKER_00 37:58

Yeah, I mean, you nailed it. I think the quickest piece is that, you know, you're not selling something. You know, we feel so, we feel like we're selling a product. We're not really just offering a better outcome. And when you really start to do this work and you can see that you have an option that's better than what you've been, you know, working on it. And you're a surgeon who's like, you know, kind of converting to non-surgical, and then you still have that beautiful surgical skill because there are still people that need surgery, right? So, but like that idea is like I'm actually offering you a better, less invasive outcome. And when they believe that you believe it and that you like you you've seen it and feel it, it's not a sales, it's trust. They just trust that you believe in what you're doing. You know, I think that's the beauty of the stuff you're working on, and people are working on is like we're here to educate, like, you know, you know, a high tide rises all ships. And I think back in the day, people were like a little bit more territorial over this stuff, and now it's just like we got to get this to everybody. There's no shortage of pathology. That's what I always tell people on our webinars like, no shortage of pathology, do not worry about not having people to take care of.

SPEAKER_01 39:04

Absolutely. So here is where that next step takes us is like, how do you educate yourself to be wildly successful? So, as you know, and I've talked to you at length, and this is part of Toby, and this is coming alongside Toby in Las Vegas August 21st. And this is really helping to have success in our clinics so that we can continue widening that array of patients that we can serve where they're at. We don't have to wait until they get worse to do surgery on them. We can actually back that up and start the process sooner where we don't maybe have to ever have surgery. We can modify the disease so that surgery never has to be that final option. And so this is our course. This is why you know you should not miss this, right? A step-by-step roadmap to get the pricing right, get the right patients, how to integrate seamlessly. And let's face it, if you can't run a profitable practice, then you can't offer these options for your patients. I think the saddest thing that I have seen recently is the fact that Yale shut down the regenerative program because they cited that it was not that they it wasn't profitable, they could not keep the doors open. And I was just like, oh my goodness, just change your pricing. I mean, like you're now because you mispriced it, all of these patients are now missing out on that opportunity to have something that is a less invasive disease modifying procedure. It's what a travesty, in my opinion. I'm so bummed about it.

SPEAKER_00 40:49

Yeah, I mean, you bring up a good point. And I mean, look, sometimes if you look at the cost structure, you feel bad, you know, creating a higher price to meet your expenses. But in the end, have you seen what some of these procedures that we do bill out from the insurance and what the people insurances end up paying? And like you realize you're like, wow, it's not that far off. It's just the cost of healthcare. And people understand that, you know, one thing that I've noticed, I'm in a full practice where we take every insurance, I get paid by RVUs, but there's a cash component. And at the end of the day, people understand that their insurance doesn't cover everything anymore. It's not, I don't get the what do you mean they doesn't cover? They're like, Yeah, no, I figured that. Like, no problem. Like, people are accustomed to paying for things. And so there's room to leverage that, and it's okay to do that. And that's the part we have to kind of get over in our heads.

SPEAKER_01 41:37

Well, and I remind people that there's a lot of people who are on these high deductible plans and they've got to pay, you know, $5,000, $7,500, $10,000 before the insurance will even kick in. So if I come in under that number, I'm actually saving them money, right? And they're getting a better option besides cortisone or surgery. So yeah, I don't feel bad at all. You know, I offer all the options and I said, you know, none of these are wrong. This is the one I would recommend, but let's talk about all the options.

SPEAKER_00 42:12

Yep. And I think that's the most important thing. And actually, that's part of this informed consent process, too, that people forget. Like, you got to go over alternatives and those things as well. So it's all part of the process, I think. And it sounds like you're setting up things where give people a process because you cannot be successful in ortho biologics without a process.

SPEAKER_01 42:31

Uh no, sir. It's a system, right? You it's just like learning how to read an x-ray or an EKG. There's a system to it. Yeah. Uh so well, I want to thank you again for you know participating and spreading the word about what you guys are doing. And I hope that we just continue down this really exciting track of really pushing the science, pushing the envelope and showing what's possible and not being afraid of being on that leading edge. And, you know, as long as we're on the forefront and we're collecting data and we're having this informed consent and we're doing studies and we're doing all these things, somebody's got to be doing those things to really move the science.

SPEAKER_00 43:16

Um, yeah, it's super exciting. And, you know, you mentioned Toby, and this year there's gonna be a whole section on you know MSCs and allergenic MSCs. And we have some great international speakers as well. So it's super exciting. It's here kind of, and it's time to start learning about it. And I still don't think it's taking anything away from autologous therapies anytime soon. I feel all these therapies are gonna have a role, so I don't think it's something to fear. I think we need to embrace all the options that we now have that are coming our way. So thank you so much for having me. This was really great chat.

SPEAKER_01 43:47

Yeah, yeah, thanks so much.