Autologous Orthobiologics Vs. Birth Tissue Products | Conversations in Regen Episode 3

Are you confused about the debate on autologous orthobiologics vs. birth tissue products? You’re not alone! Understanding the differences between these regenerative medicine options is essential for making informed decisions in musculoskeletal injury treatment.

When it comes to regenerative medicine, how do you decide between using your patient’s own autologous tissue or opting for birth tissue products? Are birth tissue products truly effective, and what does the FDA say about their safety? If you’re in the field of musculoskeletal treatment, these questions are crucial for patient care. In this video, Dr. Ariana DeMers and Dr. Jason Dragoo break down the latest research, controversies, and upcoming innovations in orthobiologics and regenerative medicine. We dive deep into platelet-rich plasma injection therapy, best practices for PRP treatments, and how to navigate the ever-evolving orthobiologics market.

We’ll explore the real science behind Platelet Rich Plasma injection injection therapy, its effectiveness in treating musculoskeletal injuries, and why PRP training courses are essential for professionals looking to expand their knowledge. Additionally, we’ll discuss the role of adipose-derived treatments, the potential return of birth tissue products in 2026, and the challenges of integrating these treatments into everyday clinical practice. What does the future hold for regenerative medicine techniques? How can orthobiologics and PRP injection therapy help patients avoid invasive surgeries? These are the questions we’ll address in this comprehensive discussion.

Join us as we uncover the pros and cons of various orthobiologic treatments, from PRP training programs to autologous biologics, and discuss how to select the right patients for PRP injection therapy. We’ll also examine real-world case studies, explore the latest FDA regulations, and highlight strategies for ensuring the best patient outcomes. If you’re a healthcare provider, this discussion will give you valuable insights to enhance your practice and patient care.

Don’t miss out—stay ahead in the growing field of regenerative medicine and musculoskeletal treatment! If you found this video helpful, be sure to like, comment, and subscribe for more insights on orthobiologics and regenerative medicine. Have questions? Drop them in the comments! Also, check out my training program in regenerative medicine for in-depth PRP course materials and expert guidance. Stay connected for future discussions on cutting-edge PRP injection therapy and regenerative treatment strategies!

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_01 0:00

Because when we look at those surgeries, those joint replacement surgeries, oh my gosh, this is barbaric. What up the heck are we doing?

SPEAKER_00 0:07

Platelets are not our friend in muscle injury. You have to pick your patients right. And I'm gonna stand and say, we don't know how to pick our patients yet.

SPEAKER_01 0:15

And maybe some of you are thinking, how am I gonna be successful? Why am I struggling to be successful to capitalize on this $4 billion $biologics market out there? We deserve more. We deserve better. Why is this so hard? It is my belief that orthobiologic treatments for musculoskeletal care will be first-line treatment in the next five years.

SPEAKER_00 0:38

If it's me, my best friend is a Talgus Biologics. Using the non-approved product is not advised at all.

SPEAKER_01 0:45

The train is leaving the station. And if you're not actively offering these treatments for your patients, you gotta get on the train. 2026 is gonna be the revival of some really cool things that we can use for our patients. We're gonna start with Orthobiologic's knowledge. Thank you all for muting yourselves. I really appreciate it. And this is going to be exciting. I am so pleased to welcome our esteemed guest, Dr. Jason Dragu. He has been gracious enough to join us tonight. And so what we'll do is I'll go through this, and then this is definitely a do not miss conversation with our friend and uh esteemed colleague, Dr. Jason Dragu. So welcome, Jason. Thanks so much for joining us. Of those who don't know who Jason Dragu is, he is a board-certified fellowship-trained sports medicine orthopedic surgeon. He is a professor and vice chair of academic affairs and a pioneer in the field of biologics and regenerative medicine. He's also a pioneer in minimally invasive sports medicine procedures, and he is the endowed chair of regenerative medicine and has developed many procedures designed to augment healing of the patients. And so Jason is the head team physician for the Denver Nuggets, which is near and dear to my heart since I grew up in uh in Denver. And he's the director of UC Health Stedman Hawkins Clinic in Denver and the CU Sports Medicine. So without further ado, this is me. Those who don't know me, I'm Dr. Ariana Demurs. And the main thing that I want you to know is I am passionate about helping doctors incorporate orthobiologics seamlessly in your practice. So thanks for joining. I wanted to invite all of you to just kick back and relax. This is gonna be pretty informal. This is basically what happens when Jason and I get together and shoot the breeze and talk about nerdy stuff uh that we love like orthobiologics. So that for me is really great. And so I wanted to invite you to kind of be a fly on the wall of what happens when friends get together and talk about this awesome field of orthobiologics. So Jason Dragu is uh not only a friend and a colleague, but really um a beast of a man in the field of orthobiologics. So we'll get to this, but I wanted to talk a little bit about this thing called orthobiologics. It is my belief that orthobiologic treatments for musculoskeletal care will be first-line treatment in the next five years. The train is leaving the station, and if you're not actively offering these treatments for your patients, you gotta get on the train. So that's where we're headed. And I know I want a successful orthobiologics practice, but it is hard. Trust me, I know. I've been there and done that, but I've also come out on the other side, and that's why I want to share this with you. We know orthobiologics is the best treatment for our patients, but the question is how do we be successful at this? You know, maybe you've tried some things, maybe you've done some marketing or you know, talk to your patients and they're not interested. But the problem is, is a lot of us say, ah, I don't know. I don't know the science, I don't know all the support, I don't know the techniques, I don't know how to run a cash business, I don't know how to do marketing, I don't want to be a sleazy salesman. You're not wrong. We've all thought this. And and maybe we've thought, well, maybe I'm just not good at business, but it's not your fault. You didn't, we didn't learn this in school. And so maybe some of you are thinking, how am I gonna be successful? Why am I struggling to be successful to capitalize on this $4 billion orthobiologics market out there? Some of you are thinking, yeah, we deserve more. We deserve better. Uh, why is this so hard? So the question is, and I want you guys all to just kind of put this in the chat, what's the thing that you're struggling with the most in your current orthobiologics practice? And maybe Jason and I can kind of delve in and help about what what it is and why it's so darn hard. So, next, we are going to be talking about how we win this. And while we're actually just talking about the science, we also need to consider how we talk about this with our patients. So our patients win, and we win at this game called orthobiologics. So you do need a system, and and we're not gonna go over all this today, uh, but orthobiologic knowledge is key. Getting the right patients, creating your cash-based business, having converting consults so that you are having patients that say yes, and then putting it all together for success. That's what we really need. And we really need a successful system to allow you to be wildly successful in your orthobologic practice. So, we're gonna start with orthobiologic's knowledge. So, Jason, let's get down to business. We're gonna be talking about science today, um, and we're gonna keep in mind how do we talk about this with our patients? But the first question, and this is a burning question, and honestly, I could probably ask you questions all night. There's this discussion about birth tissue products versus autologous orthobiologics. Friend or foe, right? I get questions every day. Well, why can't you just do that? That amniotic, don't I want that umbilical cord stuff? Isn't that better? Isn't that younger than what I'm doing right now? So, what what's your thoughts? What's your take on this?

SPEAKER_00 7:39

Well, number one, great to be here with you guys. There's always great conversations and thanks for joining. And I hope we can even you know chat more in the uh chat with additional questions that you guys have. But we struggle with this all the time. And I think neither one of these are a foe, but how much of a friend are they? And so maybe we can talk about them, you know, individually. And I think maybe most of you on the call here tonight know that the FDA has taken the birth tissues essentially off the market. Well, why did they do that? Well, it was the allograft suppliers, so the supplier of tissue for surgery, they said, Well, this is allograph, so we're gonna sell allograft. It's okay for us to do that, but then they market it as a biologic. And so then that's different. So the FDA said, Well, wait a minute. There is there is so much difference in between the different products that are coming out from these tissue suppliers that there's just no control. And what happened, as you guys may know, is that there were a couple of suppliers that were uh delivering products that were not sterile that led to some massive infections. And so that's one. Number two, there was a lot of marketing about, well, this is a stem cell injection. And then a lot of basic science showed there were no stem cells within many of these products. So I think overall it's not a faux. There's some really great biological molecules and factors within birth tissue products, but it just needs to be refined and somehow overseen. And to be honest with you, I'm on the side of the FDA. We just need to clean it up a little bit, and I think then they're really gonna be a friend. I'll give you some examples of maybe some patients that I, you know, really think about using birth products, and then I'll tell you a little bit about, you know, when they're gonna be coming back on the market. Uh, but what about uh the patient comes in and they have lupus, rheumatoid arthritis, and they come and say, geez, I have a lot of inflammation. I tried my medications by my rheumatologist, but I really want to have an injection in my knee because my knee is really bothering to me. Okay, well, what do we do? Now, as physicians, do we then draw the blood of somebody who has an inflammatory arthritic condition? We know the blood is abnormal. Is that gonna make a good biologic? Is that gonna make good PRP? Can we just draw their bone marrow and that would be okay? We just don't really know. And so then that's just one possible patient. The other one, of course, is a common thing of cancer. And okay, I have a certain kind of cancer, okay, but it's it's being treated, okay, great. Chemotherapy. Ooh, wow, what does that do to our blood and to our platelets? And maybe most importantly, if there just happens to be a couple of cells that are floating around of let's just call it cancer cells, what would happen if we if we spun those down and then injected that back with our PRP product? You know, all of a sudden then there was a you know a tumor in the me. And so then it's tough. And and and Liz, Ariana and I and you guys saying, geez, I wish I just had something else, right, that we could give other than italy as biologic. And hence I think there is going to be a place uh for birth tissue products. And I wanted to say that there is one company, and probably shouldn't mention it in and just for you know science in general of just keeping neutral, but there is one company that is really far through the FDA process of having their amniotic tissue suspension product come back to the market for the treatment of osteoarthritis. They're in phase three trials. And then if all things go per plan, we'll have that available all of us in 2026. So that's just the the best of the forecast of when they would get through there with their biologic license. So birth tissue products will be coming around the market. I just want to say one more thing before we leave it, and that is that be careful out there. You know what I what I've also seen is emails uh being sent to me and to others within our university saying, hey, I we have a brand new amniotic product, it is fully FDA approved for use, so therefore there's no danger, and that is false. False advertising, false advice. And if you look at again through the FDA and the Federal Trade Commission, folks that are using uh this are being, let's just say, scooped up, and that's closing down their practices, etc. Not advised. We have lots of good things to use now, so to use a non-approved product is not advised at all. So I just highly caution. Anyone who's coming into your office is saying that we have a birth tissue product that's uh otherwise okay to use per the FDA. So, you know, it's gonna be a friend. Right now it's a little bit of a faux, but hang on, there's good that's gonna be a really good new addition to the products we can use in biologics.

SPEAKER_01 12:57

Awesome.

SPEAKER_00 13:02

You know, if you look at the FDA and science, what better can we do than use our own tissue to augment our healing, right? It it it's it kind of doesn't get better than that. Well, why? Well, because anytime that we're dealing with allogenic tissue, there are many things that can happen with that. And we always think that stem cells, so to speak, peripheral cells are privileged, but the more that we see with the preparations, there are some reactions, and it's what the FDA says too. And I think if you're doing this long enough as we have, and you have patients coming in with allergenic products that are, again, not the FDA approved, but they come from a private clinic with a massive problem. Mostly it's orthofibrosis, sometimes it's an immune reaction with severe swelling, uh, sometimes it's infection. But bottom line is if it's me, my best friend is a Tolgus Biologics.

SPEAKER_01 14:05

Awesome. So, what did you tell that patient who historically had a birth product tissue before the big moratorium went down and they had great results? And they're like, you know what, doc? I just want that. I don't care, I just want that. What do you tell them?

SPEAKER_00 14:24

Yeah, well, it's coming around the corner. And between now and then, we have products that have been showing. I mean, there's not a whole lot of comparative trials, but certainly again, trials that show that uh many of the biologics that we have have good efficacy and really showing, at least not comparative research, but one research paper compared to the other have stronger results than the products of the birth the birth tissue products. So, what I would say to them is we're gonna be first in line. You as a doctor are going to be in touch with the the company who will then tell you. So you would be first notified when this is available, although we'll all hear about it, but you'll be notified so then your patient feels really comfortable that you are in control, you know when it's gonna be there, and you'll be able to give them that same or the best product that's available. Until then, then there's some other things that we can do to help you with it, and then go down your own experience of what has been best. And I'll just say, you know, for me, more recently, there are two things, and I'd love to compare your notes, Ariana, but there are two things that really have had the power of the amniotic tissue suspension, you know, or the amniotic injections that are pretty consistent. One is the combination of leukocite poor PRP preparations plus high ironic acid, so that combo. And the combo has really changed it. And the reason uh for it is that the length of treatment uh effect has been much greater than either one of them alone. So I think for folks with troubling conditions and osteoarthritis, that's been a go-to for me. The other one is the adipose-derived treatments, and I I do have to say that I mean I think the literature shows that um the truth is as far as decreasing inflammation and decreasing pain, but the adipose tissue preparation products, again, the ones that are FDA approved, there's at least a couple of them, have really been go-tos as well, powerful biologics to treat inflammation, pain, and the symptoms of arthritis.

SPEAKER_01 16:38

Awesome. Yeah, awesome. Well, thank you. I am gonna just make sure that we don't have any questions in the chat. If anything comes up, if you guys this is interactive, this is that fireside chat. If things come up, you're wondering about things, please, please, please. If you're wondering about it, I guarantee you somebody else is wondering about it. Put it in the chat. I won't call you out, I won't tell you who who said it, but ultimately, if you're wondering about these things, please don't forget to put that in the chat. Uh, so we have questions, Jason. Here's our second question from bench top to bedside. How close are we to getting personalized regenerative treatments for the single patient? What are your thoughts on that?

SPEAKER_00 17:30

Yeah, well, I think it does depend on what you mean by personalized regenerative treatments. Can I maybe um give you an answer? And if you're looking for something different, then you know let me know. But what I see is the the big thing for regenerative treatments, right? If we're gonna use that word, then we're gonna take it saying we want to see tissue production. I'll just say it that way, right? So what have we seen? What has shown these more consistent results with regenerative uh tissue treatments? And for me, it's been dosed biologics, right? Well, we've done myself personal randomized controlled trials. We're just about ready to publish it with lower numbers of cells that are more minimally manipulated, FDA you know, approvable strategies, and we haven't seen a lot of regenerative, true regeneration, such as articular cartilage, tendon, that sort of thing, with a couple of exceptions. But when we're getting into this next ability to treat our patient coming in the United States, possibly late 25, probably 2026, where there's quite a few companies that are developing more of a quantified ability to give us a number of cells that we could again have a dose of a higher number of cells. And if you look around the globe, these are the treatments that have led to regeneration of articular cartilage, etc. So I do think that we're pretty darn close, right? Because the world is ahead of us. We kind of have an idea of how many cells it's going to take to be able to regenerate tissues, something like 50 million cells, just to give you an idea of kind of what we're talking about. And there are a couple of companies that are midway through the FDA process where you would, as a physician, harvest some adipose tissue or bone marrow, send it to these companies, they would then culture the cells, they would then get the number of cells that you would want as a physician, put it in a vial, send it back to you, and then you inject it in their knee. That is gonna be impressive. That's a next level of where we are now, and that's coming, you know, within a couple of years. So I'm really excited about that because, you know, again, look at the world's data, that's where it's at. We do have some things now. I don't know, again, personalized. We have some regenerative treatments, such as we're doing more research on it, but platelet plasma and muscle regeneration. Oh wow, you know, there's there's really something there. And again, this came from the bench when we made a mistake in the laboratory and the PhD was was crying and said, I'm so sorry I messed this up. I was like, show me that results again. And what happened is that we were studying PRP for muscle regeneration. They spun out the platelets, they made platelapore plasma, and all of a sudden, there was multi-nucleated spindle cells in the culture dish, right? And not exaggerating. You see the papers, you know, that were published. And so then we said, wow, let's just see if we could do this again. And then, you know, the same sort of thing. Let's do this in the animal. And we did it in a couple of animal models, and then it it was also uh regenerative, and then we are getting MRI now on our athletes. So that has been a really cool regenerative treatment, personalized, I guess, you know, from you know, your own platelet pour plasma, and uh it's a regenerative treatment. But I wanted to tell you one little corollary because even if you're not a believer, the basic science is there from the bench, again, I think bench research is powerful, right? Because as Ariana said, it brings us good data for the bedside. Now, if we can't get anything to work on the bench, right, or in the cellular animal models, then it's tough to think that it's gonna happen if we're just gonna clinically translate it. So this is a powerful study because it's proven in basic science, but then all you stem cell research researchers out there, I'll ask you this question. And that is if you have a stem cell and you want it to make muscle, what would you choose as a basic scientist to make your cells in the laboratory turn into muscle? And you know, if I don't know if anyone's on, but if anyone is they There, they would say, Ah, we use horse serum. It's this thing that we've been using for the past 30 years, or at least 20, to take adult stem cells or mesenchymal cells and turn them into the muscle lineage. And so then when this whole discovery came, then we said, Oh my gosh, maybe this makes sense. This is platelapore plasma. We've been using horse serum. There's something in the horse's serum that was making this take effect, and now we see it again in our plasma serum, etc. So I think it's coming full circle, very exciting. You're going to see randomized controlled trials coming by the end, I hope, of 2025. We're trying to pump those out as quickly as possible. But that's a personalized approach. And then, of course, we get a little bit further down of being able to gene edit, take cells from a patient, which we're doing now, figuring out what genes are not working in that cell. So we're doing on a tendons for disclosure. And then we're able to we're able to reset those tendon cells to become normal tenocytes by adding genes. Well, can we do that? No. Are we going to do that, be able to do that next year? No. But you know, in the years to come, that's a very personalized process by studying the cells from patients and then seeing what genes are not working, and then being able to correct that through biologics, through gene editing. And so that's the future. That's not that's not as close as what I talked about as dosed biologics, but I think overall that's where we're working for in the future because that's going to be ultimately powerful.

SPEAKER_01 23:47

Yeah. So we have a couple of questions, and and I had this question as well. So I'm so glad uh someone put this in. What viscous supplementation combo do you use with your PRP? Do you have, you know, a high molecular weight that you prefer? Um, and then do you only use it in knee, or do you are you putting it somewhere else as well?

SPEAKER_00 24:06

Yeah. So the first part, which hyaluronic acid do you use? And and as you alluded to, high molecular weight, right? So there is no difference. We haven't studied it well enough. I can't tell, you know, that there's a difference between the high molecular weight, you know, greater than six kilodolms, that's that's synovial fluid, right? That's the reason high molecular weight is thought to be better. Clinical data shows that it is compared to low molecular weight or less than six. So that's kind of that's what we're talking about. There are three products on the market now, and again, there's no difference than I could tell between it. There's no data to show that one of those products are better than the other. So what do we do? We say, all right, which one of these high molecular weight HAs is insurance gonna pay for? And that's that's how we do it. And if one pays for Duralane, great. You know, if one pays for Jowon, great. If one pays for Synvis, great. But that's the way we do it. We're not running a trial on it, but I would use the high molecular weight and the experience and experience with others who we're we're working with on the trials in other universities also are using the high molecular weight versions of the hyaluronic acid. Well, mostly we're doing it in knees. I do mostly knees, but certainly I've been I've done this in the shoulder as well. The great outlier, okay, where we just haven't had the same luck, I just want to tell you, is in the hip. And I think the reason is is just maybe because of the volume. You know, we're talking about two medications here. The volume we use in the knee is somewhere around seven mls, you know, a fluid, four and three, you know, three of HA, four of uh PRP. So now that's fine in the knee. Well, you're not doing that in the hip, right? Because there's not enough volume. So is there enough volume to have two different kinds of medications? And what about in the acetabulum? Do these even how how much do they actually get into the acetabulum become a part, you know, of of the answer to the question? So I'll just say it's been a little bit less exciting, the results of the hip, but but certainly in the shoulder and definitely in the knee, really good results with those.

SPEAKER_01 26:32

Cool, cool. And then I this is uh the you know, our audience is so darn uh smart. I'm so glad they're asking all of my questions. What is your protocol for the muscle tear and PPP? How much blood do you draw? What amount of PRP or excuse me, PPP are you injecting? Are you pulling that out? What are you like? I have had really I've struggled to kind of quantify. I know what the research says, but these people come and they're like limping around, they're like, man, this is a really bad tear. Then they come to see me, I'm like, oh, that is a big old hematoma in there, brother. And then I like talk to them. I'm like, okay. My my last one was a surgeon, right? They got injured deep sea fishing, and he comes back and he's like, I am, I can't operate on this dumb thing. I'm like, okay, well, we can aspirate it and you know, inject it. And he's like, Okay, let me think about it. Let me put a wrap on it. And he's like, Yeah, I'm good. I I'm okay. But what do you tell your patients? How much are you aspirating and injecting? Like, what's your protocol for that?

SPEAKER_00 27:32

Well, this whole thing has been interesting to study. So, a couple of things from the beginning. So, number one, I have always really believed in the Scandinavian trials that say that if you have a muscle tear and you have a hematoma, that a hematoma will displace the ends of the torn muscle fibers and therefore you will have a bigger scar interface. So then aspiration of the hematoma and acute muscle tears has always been part of the formula for for me and the high-level athletes. If they don't have it, obviously there's no aspiration. But looking at it under ultrasound, if they do, that is that is step one. Step two, maybe it was part of a little bit of the question that is, well, do you do just platelet pore plasma or PRP? PRP, both in the basic science laboratory as well as in the clinical trials, has not been showing good results. So I do not use PRP just for clarity. The platelets drive the muscle, the resident satellite cells into a different pathway of fibrosis and multiplication, but it doesn't turn them into muscle tissue. So PRP, no, for me. Finally, what's the protocol? And for me, if you look at this, muscle has to go through the initial stages of the sealing up of any healing that's there, etc. So when platelets are present, then this pot this process has less of a chance for working for the reasons I just said. Platelets are not our friend in muscle injury. So the protocol is to calm down the knee aspirate the muscle, calm down the muscle for a period of time of one to two weeks, and have them come back for the injection at somewhere between 10 and 14 days. The reason is because most of the platelets around the local area of injury have been depleted at that time. So then if you replace it with play the poor plasma, quite possibly you'd have a better result. And so then that is the timing of it. Now, the the other part is the volume. I think this is really important, but there this is controversial because there's some great investigators from Emory University, Iowa, etc., who use higher volume treatments than I do. But I really do think, again, the Scandinavian literature is that basic science is incredibly good. And so then I don't want to be displacing the muscle, the muscle fragments or the fibers with too much volume. So typically what I do is I put around one CC and a maximum of two in a muscle injury, and then maybe a little bit subfascially within the muscle, but not using big volumes. So the most I ever have in my syringe would be three, and then the most I'd use around the muscle is two, and then again uh subfascial, quite possibly one, or maybe one and a half and one and a half or something, but the volume is low, and I've had much better results when we look at our follow-up MRIs with low volume versus larger volume.

SPEAKER_01 30:53

Yeah, and then that follow-up question, uh, this is so fascinating. And I'm I thank you so much for being willing to just kind of go freestyle. But for the muscle hematoma, if it's organized and you can't aspirate it with an 18, like do you just roll with it? Do you let them come back or say, oh, it's too late? What do you what's your thoughts on that?

SPEAKER_00 31:15

Yeah, I mean, we don't really know. I think, you know, in the real old showing my age, we used to use enzymes in there, and I think that's completely fallen out of practice for good reason. Uh that's just not the beneficial thing, obviously, to break down a hematoma. So, you know, there could be a little bit where you can put in some saline and then try aspirate it out, etc. I don't do that. And so then there is the hematoma, and let's just say there's a central hematoma, it's organized, you can't get it out. I put the the platelet pore plasma on the edges of the hematoma, trying to activate the cells, the resting satellite cells. That's what happened in the basic science lab. So their cells are on the end, right? They can't really meet each other, but you're trying to activate them, and then a little bit is what it is. And hematoma is a nut is a lattice, right? Uh, it's a scaffolding. So, quite possibly then the muscles can then be able to go through the area of the hematoma. But the goal of this sort of treatment is to get rid of that hematoma so that's not there. I think to be honest with you, in the future, that's where we're gonna have the best results. If you don't, if you get these patients early and you get rid of that hematoma, even if it takes, again, two injections, one at the time of injury, you get rid of it, you see them back in 10 days, and you give them the play of the porplasma injection.

SPEAKER_01 32:37

Brilliant, brilliant, awesome, awesome. So we still have more questions. This has been fantastic. So long-term outcomes with PRP and BMC, is it myth or reality? Can we tell our patients? Oh, sure, it's a one-and-done experience.

SPEAKER_00 32:56

Yeah, well, I really do think I'll give you some caveats, but I really do think this is more of a myth than a reality. Now, let me tell you that I do believe, and I think the basic science shows this, that the effect of biologics injections lasts longer than the biologics residence time, right? Let's assume you eject PRP, and I'm gonna make it up that somehow people measure that it's six weeks, it's probably much less than six weeks of resident time. But then the question is, well, well, we typically have results much longer than six weeks. What is responsible for that? If there's no PRP, how can we have, as I would say, a medium term outcome? Depends again. Surgery language, this is all short term, right? But you know, medium term, I'm saying six months to two years. Okay, that's what I'm just saying, medium term, long term is one and done, as you said. So I don't, you know, the chances of that are low. So then the question, then as a physician, what you tell your patients, like, well, I just saw an article. PRP is gone in six weeks. Why do I, why would I think that it lasts longer? Say, well, number one, the trials say it lasts longer, but why? And the answer, okay, I think is new data shows that there are factors within PRP, and there are specific ones if anyone wants to know, but that polarize monocytes and macrophages into the M2 lineage. And that then creates an anti-inflammatory consistent environment of the joint because they are policing and producing anti-inflammatory factors. And there's another thing that's produced uh by PRP called platelet-reve of growth factor, and there's an isofraction BB that has been shown to release peripheral base mesenchymal cells, will calm themselves just between you and I, but we won't talk to our patients like that. And they, this isofraction BB releases them into the local environment. So we currently believe that these factors that polarize macrophages and the platelet-drive growth factors that release the local resident cells in that area are responsible for the longer-term benefit of PRP and BMAC. We do not think, I should say, I do not think BM BMAC um has enough cells to matter, right? So that's not giving its longevity. It's programming the local niche, so to speak, right? Of the resident cells that are perivascular and the macrophages are giving us this length of time. One and done, I'm not quite sure. And I'm certainly would never tell my patients anything like that. But so can we have expectations, you know, of this combined PRP plus HA of two years of results? Yeah, well, we do have that. So I just say I don't know what it's gonna be. It's maybe six months, maybe longer. We certainly have patients at around uh two years. So I'm not sure what's gonna be for you. That's what we're going for.

SPEAKER_01 36:15

Awesome. Now, what do you what do you make of the data from Dr. Herniew with the intraaosseous BMC with really compelling long-term follow-up, you know? Obviously, the the the volume of bone marrow drawn as well as injected is very different than what we are achieving here in the US. But what are your thoughts? Like he's repeatedly shown in a number of different body parts that this intraosseous BMC is for in his hands, in his technique, getting really long results.

SPEAKER_00 36:58

Yeah, well, there's so much to it, right? Because you have to pick the right patients. And if the bone bone component of their arthritis is not activated and you inject into the inner osseous area, excuse me, I'm not sure you're gonna get the results in everyone. Matter of fact, when we do, and even though we do have an activated uh subchondral bone, we still have a 20% failure rate. That's what the data shows worldwide. So, you know, so there's so what's the answer? Hertigo is probably right, but you have to choose the right patient. Well, how do you choose the right patient? And this is even more complicated. So, so I'll just shorten as, but there's so many parts of this. But think about this. I call this the 30,000-foot view of our patient. Come in with arthritis, they have a bone marrow lesion and pain in the medial side of the knee. And what I say is I time out. I am not going to talk to you right away about what we can do about this. I need to ask you questions about this and find answers of why your environment is like this to begin with. Why did you get that bone marrow lesion? What's wrong with your joint? Now, is it malalignment? Is it a meniscal insufficiency? Is it obesity? Is it blah blah blah, is a metabolic bone disorder, or to just have an impact injury and you overused it? And I think with then with the whole Hernago thing, absolutely yes. And quite possibly, even with a little off-loading brace, they're never gonna need another thing again, right? Because they it was an impactful type of fracture, you know, subclinical fracture, they have bleeding and edema, and you alter that and allow it to heal, you're going to be the hero. That patient never needs to come back for more. But I have trouble with severe ostearthritis, you know, with broken down media compartments, and to say, you know what, all we need to do is do one bone marrow injection in your inner osteos area, and you'll never have to come back. I have trouble with that because I can't get those results. So I do think there's something to it. I don't want to say it's not true because he's a great investigator, a great man, but you have to pick your patients right. And I'm gonna stand and say, we don't know how to pick our patients yet. He's gonna give us a lot of clues, right, about how to do it. And then I encourage us all to do our own little experiments with it. But I do hesitate to be telling our patients, hey, this is the one and done, and you don't need anything more, right? Because that has not in the United States been shown to be true.

SPEAKER_01 39:43

Thanks. Yeah, absolutely. Well, I'm so glad that you brought up the this leukocyte situation where you know our leukocytes are maybe in charge of this longer-term reprogramming. So the question is does leukocyte rich versus leukocyte poor PRP definitions even matter? Are we not talking about the right things? Are we talking about the right things? So maybe can you illuminate the situation a little bit?

SPEAKER_00 40:16

Uh yeah. Well, it's a good question. And you know, this whole thing I think is a little bit our fault. And I just want to explain a little bit. You know, when Alan Mishra at Stanford did the first PRP injection, and then we started to say, well, wait a minute, what are you injecting and and how is it working? And so we started to do trials and trials with the different components of cells and factors within PRP, and it led to the understanding that if we included neutrophils within the PRP in an animal model, it led to inflammation. And if you took that away, then it led to an anti-inflammatory effect within the animal model. And so then that's how this is born, right? So then it was this, okay. We have an inflammatory PRP, then we have a non-inflammatory PRP. And for the most part, it gave us some utility, right? To know that all PRP is not created equal. And be careful because if you put neutrophil laden PRP in a joint, be careful, and I'd be happy to address any literature that's out there from Europe uh on this. But anyway, so then it is okay, we gave it the name, but then the name over time is probably a poor run, right? Because this we have a consortium called the Barb Network, and so we're collecting peer P and we're looking at people who respond versus don't respond to peer P. And you know what we're finding? One of the the there's two big findings thus far. It's gonna change as we get more and more data, but there's two big things. Number one, in using peer P, peer P with greater platelet concentration tends to create more of response in in humans, right? So these systems, and we there's like uh literature to prove this, uh, you concentrate it 1.5 times or 2.5, there is not much response to peer P injections. So higher concentrations, four, seven times uh concentration, that's what the new data is showing. So that's number one. Number two, lymphocytes are positive. So then when we talk about this and saying, oh, well, we're gonna give a leukocyte pore, we don't want to be taking out the lymphocytes. It's a leukocyte, but we don't want that to be poor, we want that to be enriched, right? So then when you have this definition of leukocyte pore, modern day in biologics is neutrophil-depleted, lymphocyte concentrated. That's leukocyte pore, but the name's terrible, right? Uh with it. So it's gonna evolve. It was there for a reason for us to get a hold of what we're doing. It has been good for tendinopathy and understanding what type of peer P may work better there and arthritis. But you see, as we're becoming more sophisticated, these very junior varsity names that we that was given from the very beginning of PRP is inappropriate and the lines are blurred. And the specific formulation is actually which is really important. I'll give you, you know, again, there you look at the randomized controlled trials from around the world. Some Leukocy poor peer P formulations don't work. Great trials, they don't work. Right. Right, they don't even meet definition of peer P, and they certainly don't concentrate a lot of things. Other ones, they really do work. So I I think this name is gonna be going away. I think it's good for us to know this, and it gotta again away from there is just peer P. I want a peer P injection. You cannot talk like that. And now we have again more fancy formulations, and we have A2M and plasma concentration and other things where we're mining different parts of the blood compartment for different things that we want to do. So now it's much more sophisticated, probably would be another good topic of another webinar is just you know, what are these different formulations of peer pee? But you're right. These definitions are not great. I think they do matter, uh, but they're just inappropriately named, if fair, if that's fair enough.

SPEAKER_01 44:32

Yeah, maybe we'll get Alan Misher to come and talk about all the formulations and what we should name them.

SPEAKER_00 44:39

That's right. That'd be great. It would be a good battle. It could be a good debate. Get three of us.

SPEAKER_01 44:44

Oh my goodness. That's so sad.

SPEAKER_00 44:46

But I get your point. You know, it's not gonna last us into this next generation of peer pee.

SPEAKER_01 44:52

Sure, sure. Just we have a question from the audience. How long after the PPP for muscle tear can the patient go back to sport? Or what can we talk to our patients about expectations? How much physical therapy, how much rest, how much compression, when can they return back to their uh full game play?

SPEAKER_00 45:12

Yeah, well, that's that's the whole approach to athletic medicine and return to muscle tears, which is the graded force or increasing force, mostly eccentric, early stages until they go step by step for a full return to play and return to play testing, right? So it's so you're building them up, it's through physical therapy, and when they get there and when they're strong as their other side, they pass the return to play testing. We have blurred the time barrier. So this is elite sports medicine. Like you would not in modern day say, Oh, coach or general manager, hey, we got a muscle tear, he's out for six weeks. No, that's old days. Now there's no timing. It's like we're gonna give you these treatments, etc. We're gonna take you back step by step and we're gonna rehab you. And when you're not sore with this amount of force, we're gonna go to the next. I don't care what the time is. Okay, well, that generally, depending on the tear, is somewhere between four and six weeks. We might not see a big difference with the plate lipoor plasma on the actual return to play date. There is some literature that suggests that you can return earlier. We may or may not see that. But I think for athletes, if you don't have that scar tissue intervention, right, that piece in between your muscle, where that decreases its elasticity and increases the chance that you have another strain right down the road, we're still gonna win right in this, right? So that's the answer to the question. No timing to step-by-step physical therapy, increasing daily until they're ready to go and pass a comprehensive return to play testing.

SPEAKER_01 47:00

Awesome. My goodness, you have dropped the knowledge bomb on us. Thank you so much, Jason. Really appreciate it. If there's any more questions in the chat, please make sure you put them in there. So, what is the next step? How are you going to translate all of this knowledge that we just talked about, all of these pearls that are amazing into really being successful in having your orthobiologics clinic and being able to treat your patients for all of these things we just talked about muscle tears, arthritis, PRP, BMC. How do we become successful, right? And so one of these, we've done the orthobiologic knowledge in part. It's a small, we can't cover everything tonight, of course. And there's upcoming IOF and Toby and and AAOS and the BA. There's lots of things. Please, everybody, come to as many as you can. This is a growing field, and the things that we know this week may be different next week and may be different in a month from now. So super exciting. The next is Jason, just like you talked about, I think we do need to pick the right patients. And we need to figure out who those patients are so that we can appropriately counsel them how to get good results. Because we don't want to offer these treatments if we're not going to have amazing results. It's going to bring our field backward. And so we want to pick those people and those patients who are going to have impeccable amazing results to be able to drive that field forward and get the results, those 15-year results, like Dr. Hernagel, you know, the one and done, like, whoa, that is mind-boggling to me and so compelling that I just want to find those patients, find the secret sauce, the ones that are gonna be amazing and continue down this path. Because when we look at those surgeries, those joint replacement surgeries, you know, and I do those, I'm like, gosh, this is barbaric. What the heck are we doing? And then I compare it to my needle-based procedure. I'm like, oh my goodness. If I could just give orthobiologics to all of my patients, and only the worst of the worst would be treated with surgical intervention. For me, that would be a win, just for my patients, but you know, in the field as well, being more personalized, being more precise about the way that we practice our medicine. So that's our next step. You need a system, you need our practice launch system. I have put together the regen patient magnet method, how to find those patients. Because the biggest thing that I get is I don't know how to get patients. Oh, patients in my town won't pay this, that, or the other. And really, we just need to learn the way to get that. So I have put that link for this little uh webinar that I'm doing about how to pick those patients. So that's in the chat. Um, if you're interested, uh, that is the next step. And and then if you want the fast track, I'm gonna let you in on a little secret. I've put together a one-day business event. This is at IOF just before IOF in Phoenix, Arizona. It's February 27th, so you gotta get on the train and get going. But ultimately, this will be going over all of those business things that can help you become successful. So, Jason, I really, really appreciate your time. Please, I I put a link in the chat for the BOB Business of Orthobiologics Live. And if you want to register, that would be great. I'll see you there, and we'll learn how to get some really great results for our patients and get the freedom that we deserve to be able to care for our patients in a more personalized manner. So, this is what we get. It's an investment in your well-being, and I wanted to thank everybody. If there's any more questions, please don't hesitate to put them in the chat. Oh, there is a question. This is a great one. Oh, I like this one a lot. We're gonna wrap this up. I really appreciate your time, but just curious, why aren't we concerned about any regulatory issues surrounding using adipose as a source of cellular therapy anymore? Why are we not concerned?

SPEAKER_00 51:53

Well, I think we are concerned, but a couple of things. So, what the FAA cares about is that you don't destruct the adipose tissue down to the level of cells. They have approved products, two of them, more than that, that reduce, get rid of the adult uh adipocytes. You have your mesenchymal cells there at the vascular network and a little bit of kind of fragmented fat that is below a certain size, that is has been okayed by the FDA. And but what hasn't been okayed by the FDA is again uh using enzymes, getting down to the cellular level because that's a product. And so we are worried about that. If somebody's using enzymes and in a clinic and then giving pure adipost uh derived cells to it, I would be worried about the regulatory and they're gonna get shut down. It's just a matter of time. So that is a worry. The micro fragmented MFAT, that sort of thing, I'm I'm not sure, right? Because there's products out on the market and devices from companies to help produce it. I I think it's the I think that's legit things to do. Uh uh obviously check with your product that is help machine these fragments of fat and then uh make sure that it's FDA approved. That's the way to be bulletproof with it. But I think there's less policing in that area, and the more of the rogue of the allergenic cells, the amniotic, again, derived cells from other patients. I mean, that's where the kind of police are out, so to speak, right? That's where it's really they're gonna shut you down. You're doing M fat in your clinic. I have never even heard of it anywhere. So I think there's some concerns.

SPEAKER_01 53:54

I think people are concerned with the FDA, the wording about whether you're using it, you know, for homologous use. People get hung up on this, but I think that's for the marketing of it for companies. That part of this guidance from the FDA is guidance to the companies who are marketing these devices. The way that the individual physicians are using it is a completely different ballgame. And so, yeah, should you put that that you use adipose cells to treat arthritis on your website? I wouldn't. I kind of liken it, and people always ask, well, why can they sell adipose or the umbilical stem cells? Why do why do companies why can't why can they sell it? And I I tell them this do you speed when you're driving your car? Of course, we all do, right? I mean, most of us do. Uh and and that's illegal, that's not a legal thing. We are breaking the law when we speed. It just has to do with the ramifications. And so if you're speeding in your minivan versus if you're speeding in your red Lamborghini at 105 miles an hour, who's gonna get caught and who's gonna really catch the attention of the police, right? Well, it's not the the five mile an hour over in your minivan. Uh and so when we talk about that worry about the the adipost and specifically the MFAT, using the 510K clear devices, I think that the risk is very, very minimal. And then if you're not even talking about the fact that if you're using it as it is intended for cushioning and homologous use, if you read the actual uh uh literature and the recommendations from the FTA, I think you are well within your purview as a physician to use it.

SPEAKER_00 55:53

Autologus?

SPEAKER_01 55:54

Yes, autologous, not umbilical. So MFAT, yes, umbilical or birth product, no, not at this point, but maybe in 2026, right? 2026 is gonna be the revival of some really cool things that we can use for our patients. I'm looking forward to that for exactly those patients that you talked about because I really I don't have a good answer for those people currently. So awesome. Thank you so much, Jason. It's been such a pleasure. Uh, I don't see any more questions. Thank you so much for our viewers, and I really thank you again for everybody. Thanks for joining us. I hope this was helpful, and we'll see you on the next one. Thanks, Jason.

SPEAKER_00 56:36

Good evening, guys.