Why Stem Cell Treatments Vary So Much In Orthobiologic Practice | Conversations in Regen Episode 26

Variability in stem cell treatments remains one of the most important and misunderstood challenges in orthobiologics, with major implications for clinical outcomes and decision-making.
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This content is intended primarily for physicians and healthcare professionals interested in orthobiologics and regenerative medicine. Patients are also welcome to listen for educational purposes and greater understanding of evolving treatment approaches.

In this episode hosted by Dr. Ariana Demers, the Queen of Business Orthobiologic, alongside guest Dr. Karolynn Halpert, the discussion explores why stem cell treatments can vary significantly across patients, clinics, and protocols within orthobiologic practice.

The conversation breaks down key drivers of outcome variability, including patient selection, host biology, manufacturing processes, and differences in regulatory environments shaped by stem cell regulation. It also explores how these factors influence clinical decision-making in regenerative care, including platelet rich plasma therapy and other biologic interventions.
A major focus is placed on how physicians can better understand variability in response, improve consistency in outcomes, and advance orthopedic innovation through more standardized and evidence-informed orthobiologic approaches.

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

Many patients in the US can feel left behind, especially patients with degenerative conditions, chronic diseases, orthopedic, neurologic, autoimmune, and pain-related conditions, where conventional medicine often has limited options beyond medication, surgery, or long-term symptoms management.

SPEAKER_00 0:23

Best rule of thumb is if you got taught to just hold it in your hand and warm it up, that's probably the first sign that you need to find more rigorous company to be able to partner with.

SPEAKER_01 0:43

So we don't have the same amount of stem cells in our body. That's why we see that our healing slows down as we age.

SPEAKER_00 0:58

So welcome everyone to Conversations in Regenerative Medicine. And we will let everybody filter in over the next one minute or so. You know, we don't want to keep everybody waiting. This is exciting stuff that we're talking about. And so this is Conversations in Regenerative Medicine. We are exploring the frontiers of platelet-rich plasma, bone marrow concentrate, MFAT, and we're going to be talking about some more controversial pieces and topics, including allogenetic stem cell, culture-expanded stem cell. And we're going to be talking with one of the pioneers of regenerative medicine. And we'll plan to uncover some cutting-edge insights that are shaping the future of interventional orthobiologics. So without further ado, I am going to just let everyone know, for those of you who don't know me, I'm Dr. Ariana de Mers. I am a board certified fellowship trained orthopedic sports medicine surgeon and regenerative medicine aficionado. I am also an educator and trainer both in orthobiologics and ultrasound. And I have successfully moved my practice away from commercial insurance. This without further ado, I want to introduce you all to Dr. Carolyn Haupert. She is the chief medical officer at Bioaccelerator, BioexTech, and Bioex Science. She's a physician and healthcare executive, and she specializes in Wharton's jelly, MSDs, extracellular vesicles, and secret home therapies. She is trained as an emergency medicine physician and health services management, but also has a master's in health administration. And her biggest focus is on musculoskeletal, neurologic, autoimmune, and degenerative conditions. And the most important part is leading real-world evidence and outcomes programs in regenerative medicine. And this is where we met. We met at Bioaccelerator, and she has really been working very, very hard at a very high level to bring some of the best science I've seen regarding culture expanded. So we are gonna go kind of deep dive in. So, Carolyn, thank you so much. Dr. Halbert, thank you so much for joining us today from Colombia. Uh, and uh we appreciate you being here. So thank you so much.

SPEAKER_01 3:41

No, thank you for the invitation and thank you for that great introduction. I'm very happy to be here and sharing my experience and our experience. So, yeah, you visited us like a couple of weeks ago. You were able to come to Medellin, Colombia, and it was a pleasure to have you here and get to know you.

SPEAKER_00 4:02

Yeah, it was a great trip for anyone who is really looking to do the deep dive on science as well as really understand at a much deeper level culture expanded options, which are not available in the United States at current time in any meaningful fashion. I really am going to recommend and and we can send out definite ways to uh get on a call with them. It's super uh really impressive. So I did want to thank everybody for joining us. I this I want to not only just realize that this is just among friends, right? This is this fireside chat where we get to hear from internationally renowned experts in regenerative medicine, but also explore maybe a little bit more controversial topics. Maybe hear pull back the curtain a little bit and hear the real deal and also gain some actionable insights that you can implement on your practice immediately. And then finally, we get a live QA to get your burning questions answered. So I believe that orthobiologic treatments are first line and will be first line treatment for musculoskeletal care in the next five years. And here's the deal the train is leaving the station. If you are not actively offering these treatments to your patients, you gotta get on the train. It is definitely leaving the station. And I don't want you guys to be left behind. So successful integration is sometimes hard. How many of you are looking to successfully integrate, right? And you know, we know orthobiologics treatments are the best for our patients, but ultimately how to be successful at this, right? Maybe you've tried some things, maybe you're dabbling, but maybe you kind of let's say, I don't really know all of the science, I don't know the mechanisms, maybe I'm not a hundred percent sure on technique, maybe cash business as it seems quite daunting. And we all know we didn't go to school for marketing or sales. And some of us may be thinking, gosh, I'm just not good at business, but it's not our fault. We didn't go to business school, we went to medical school. And so the good news is, is this is a learnable skill. And I, for one, am looking how to be successful and capitalize on this four billion dollar orthobiologic market. And and I do think we deserve more. So if you are struggling with really integrating this as a first line treatment in your practice, make sure and pop in the chat kind of which piece is the most annoying or the hardest to kind of get right. And then we can answer that and talk about that a little bit in the chat. So how do we win? While we are talking about the science today, we also need to consider how to talk about this with our patients so that we all win, both patient and doctor. So we do need a system. And the first and foremost, we need our ortho biologic knowledge, right? And we're not gonna go over all this today, but we are gonna go a little bit further on this journey to be wildly successful in your orthobiologic practice. So we do need a system, and so we're gonna get started with orthobiologic knowledge, and Dr. Halbert's gonna take it away. Dr. Halbert, we do have questions, and so we're gonna get right into it. So the first part that I do have a question about, you know, so let's start at the highest level. What are culture-expanded allogenic cells actually doing that maybe PRP or same-day cellular therapies like Bomer Concentrator Adipose cannot achieve?

SPEAKER_01 8:00

Yeah, so that's a very important question. And I will say that they are very different tools. We have available many different biological products, and all of this have different levels of biologic complexity and different mechanisms of actions and different levels of control. So with PRP, everyone knows that it's an autologous stimulus, but it's it's very it's and it's very valuable, but in the right patient, especially when we have patients that are early or mild conditions, and where the goal is to deliver a concentrated burst of growth factors from the patient's own blood, but we need to understand that PRP has a limited, the limitation is the patient's biology, the age of the patient, the platelet count, the inflammatory status of the patient, the metabolic health, medications that the patient's taking, disease stage is very important. So, and also something important is that all the preparations, all the systems preparation for PRP are very different. So we can have many different products with PRP. As we know, we can have PRP rich loco site, low lococite, hyperconcentration of platoons, and so on. So they're all all of them are very different products. What is important is not only the selection of the right patient with the right biologic, it's also understanding like what's the biologic limitations of each product. So, for example, we know that PRP has a plateau. So it delivers temporary signal, but once that faceted growth factors are released in the local and the local response has occurred, the effect can level off, and that's why we know that with PRP, sometimes we need additional applications and not only one shot, but two or three uh continuous shots. With same-day concentrate cell therapies, such as Bomarocent and Adipose derived concentrates, also selecting the patient is very important. And this ethogen ethic ethoger, that word is very difficult for me, ethoger heterogeneous, autologous mixtures. So the combination it has like a combination of different types of cells: nucleated cells, thromal cells, placid cytokines, inflammatory cells, tissue divirical components. So the actual number of true stem cells in this type of concentration concentrated samples, it can be very low and it can actually be very virable. So all the samples can be different because it's coming from different patients. And here I like to say that the product, when we're working with products coming from a patient and having an autologous source, the patient is the product. So it's better if we are able to optimize the patient and optimize the metabolic states and the inflammatory states before getting this biologics from the patient and then concentrating and putting back because that way we're gonna be having a better product and we're gonna be having a better patient to introduce this type of products. And hope that we are following with the difference. And with culture expanded, what happens is with what we work, we work with warts and gellamycinchymal stem cells. These are the stem cells that we get from the tissue of the umbilical cord, they come from perinatal tissues. So with culture expanded allogenic cells, there's there's it's like a different biologic category. They are not simple, they're not simply a stronger PRP or a higher dose of the same day concentrate. They are a living biologic product that can be selected from different tissues, from different different sources, that is gonna be expanded and controlled under control conditions, is gonna be characterized and is gonna be delivering, be delivered with much bigger consistency so that we don't have a lot of viability between the products and the in the preparation, so that it's all standardized. So, from regenerative medicine perspective, this is a major difference because we are no longer relying on on what the patient's on the body's condition of the patient of that exact day when we were able to get the PRP or when we were getting the concentrated product, but we are working with a more controlled cellular platform. So, and this matters because many patients that are seeking for regenerative therapies, they already have some aging in their body, some biological aging, chronic inflammation, chronic disease, metabolic dysfunction, mitochondrial dysfunction, or poor repair capacity, as we know, and it has been published, the number of stem cells and the function of the stem cells decrease as we age. So we don't have the same amount of stem cells in our body. That's why we see that our healing slows down as we age, and this is and this is very important when we're gonna be selecting the patient to go with autologous or if we decide to go with allogenic. So here we have to really choose the right biologic, choose the right patient, and select the right condition and the state of the condition. But all of these biologics are amazing, all of them work. We just have to be very rigorous with the selection process.

SPEAKER_00 13:53

Yeah, so I I will share a little bit that you know when we when I came back from Colombia and I was feeling a little sheepish because in in the United States we don't have this ability to be so rigorous in choosing because we're only, you know, have our autologous therapies for the most part. Now, that is changing rapidly right now, which is really exciting that the the door is opening. Uh, so that brings us to my next question. That there is a growing narrative that the US is overly restrictive while other countries are advancing. Do you believe that the patients in the US are being left behind? Or what's your perspective on this, especially now that, you know, gosh, it seems like every week there's new legislation regarding stem cell therapies in the US? So what what do you think is happening with the patients right now? Are we behind?

SPEAKER_01 14:51

Yeah, I I do think that many patients in the US can feel left behind, especially patients with degenerative conditions, chronic diseases, orthopedic, neurologic, autoimmune, and pain-related conditions, where conventional medicine often has limited options beyond medication, surgery, or long-term symptoms management. And I also believe that other countries like Colombia are moving faster in certain areas of regenerative medicine, and it's because their governments and regulatory agencies have created pathways that facilitate responsible innovation rather than simple, simply restricting access. So, for example, it's very interesting, Japan and Europe, where they have created specific regulatory frameworks for specific regulatory medicine products that allows them to work with this while they are proving safety and that it works. And I do think the FDA it has been very restrictive, but I also believe that it's important that these regulations exist so that we can protect patients and that we can protect the field. So people being cautious, it's very important, but I think that we we should not stop or we should not slow down advancements innovation with very restrictive regulations. I think that we just have to find the way that we can have some that we can have regulations that allow us to do this in a very responsible way, making sure that we are not harming patients. But regulation must exist. Like it's a must.

SPEAKER_00 16:42

Right. Yeah, I it and really it's still in the United States, it still is pretty deregulated or or unregulated, even though the FDA has been restrictive. So it's still really interesting. I think we're still really early. But I do I do see that there's better options outside the states where these things have been really responsibly tested and tried and when we're relying on that real world data. So we still have more questions for you.

SPEAKER_01 17:16

Let me complement that with another idea, another thought, that it's for example, when there is high restriction environments, it also can create like unintended consequences. So, for example, in the US patients having to go to other countries, having to fly to other countries to seek for this type of treatments and technologies. And some of them end in unsafe clinics with no serious medical oversight, no manufacturing standards, and no follow-up. And other ends and others end up in more serious centers that are physician-led, led, protocolized, integrated with manufacturing, and committed to data collection as we are, that we have all the integration from the clinic, the research center in the manufacturing where we have the lab and we produce our own products. And and and from from but from the patient's perspective, it can be very difficult for them to distinguish between those two different types of actors and those two different types of clinics. So that's also something important. And also when there's high regulation, another consequence is that some physicians in the US or in other countries that are very high regulated are already, they are already using biologic therapies in in and in ways that they might be putting themselves in a regulatory risk. Because as we know, we know that culture and expanded stem cells are being used in the states by by doctors. So if they're putting themselves in an unnecessary risk, and when and when the field is forced to go like underground or into a legal ambiguity, that is not good for patients or for physicians, and that actually reduces transparency and at the end quality and safety. So I think that there have to be a balance between how much regulation, but that we don't over, like we don't exaggerate with regulation, but that we don't either don't have regulation.

SPEAKER_00 19:29

Yeah, yeah, absolutely. And I was just gonna say, you know, the the there are critics of the international stem cell clinics that are operating in some pretty unclear, maybe unsafe manners. And what would you say? Like, how do physicians vet these international clinics? Like, what are the what are the top ways that uh like if I my patient is thinking about going to an offshore clinic? Because I've this has happened where I'm like, gosh, and that's part of the reason I came to visit you guys is because you know, my patients are asking, like, which one's good? I heard, you know, it Joe Rogan went here. Like, that's probably not a really great way to vet your stem cell clinic, but you know, he didn't die, so I guess he's uh he's good to go. But ultimately, what are the top three things that are the that are the good clinics, responsible clinics, are most transparent about?

SPEAKER_01 20:31

Yeah, so I think that the right question is what standards are they are are they actually following? So the key question is whether the clinic has real medical, scientific, and manufacturing standards, if there are licensed facilities, is their specialists and physicians led in the patient selection, controlled cell production, donor screening, product characterization, sterility, viability testing, if they really have written protocols, if they're being ethical, if they have ethic oversight, if they're tracking adverse events, if they're tracking data and outcome measurements, if they are really like working with real-world evidence and real-world data. And in that transparency has to be proven, proven and not like promising. They have to prove it. They have to show they have all of that. And not all the international clinics are doing it correctly. In fact, very few are, and there are only a small number of international centers that are really truly trying to build this field in a very responsible way, with medical responsibility, with scientific discipline, with manufacturing protocols, with clinical programs and protocols, and with outcome measurements and data. So I think that physicians in the States should be open to listen. And curious and asking like the right questions. For example, us by accelerator, the model that we have created is that we have the research where we're collecting all the data, where we're doing all this follow-up, and we're with all this data, we're able to continue improving our protocols and our products. So we are really actually seeing what is happening with our patients. We have the clinic side where we have all our trained specialists, and we have more than 14 different specialists. And we have the lab where we're manufacturing and we control every step of the process from the donor selection, bringing the umbilical core to the lab, culturing and expanding, and doing all the quality control that is necessary and all the controls that are necessary, and doing the responsible release of the product that is good and safe to use in a patient. So when when you don't control all of those steps, for me it creates a lot of concern because things that I'm seeing on the field is that clinics and doctors are purchasing products to biotechnological companies. And I don't think they know what questions to ask. And I don't think they are, and this is what I love what you're doing. This is a lot of education, and it's super important, all of these education, so that physicians actually know what are the right questions they have to do to be sure that they're working with a good, high-quality, potent, functional, viable product and safe, and that they're not gonna end harming a patient or just administrating dead cells or or or a product that is not functional or active at the moment of application. So education is very important with physicians. We don't get educated on this field when we were going in the universities. At least I'm very happy to see that in the last five years, there's many, many courses and training programs and educational programs that are coming out, which I think that it's super important. We need to educate our colleagues and the physicians so that they really know what they're using, what's the characteristic of the products, and that at the time of injection, what are they, what is that they are injecting? Because in the quality certificate at the lab, it can say many things, but that's at the lab time. That quality certificate is not the same when you have a product that you're gonna be injecting. And I'm here only talking about culture and expanded products.

SPEAKER_00 24:42

Great. Yeah. I and I think this is a this is an evolving like set of questions that we're asking as as the FDA and as states pass state laws, it's a state-by-state law, they're all different and the requirements are different. But I do think that those are part of some of the laws. I know at least in Florida, that we there has to be post-violity testing, but it doesn't have to be at the at your clinic. It just has to be a certificate of post-violity testing, right? Post viability testing. So I I think it this is definitely an evolving uh science and an evolving field. And and as long as we can continue to can just have that conversation and have this continued education and and help doctors do what's right for their patients. So what patient populations or diagnoses for you have you seen the most compelling results for culture expanded versus you know autologous therapies? And then more it moreover, you know, where do these therapies not perform well?

SPEAKER_01 25:54

Yeah, so I think that the where where you can see if there's inflammation, degeneration, pain, impair, repair, immune dysregulation, uh, and that there's still a viable tissue and a host capable of responding, there could be a biologic response with biologics. We are very strong, our experience, we are very strong in orthopedic and musculoskeletal conditions, such as degenerative disease, neostartitis, chondromalaasia, tendinopathies, and many orthopedic and sports-related conditions, acute and chronic injuries, and and it's where we have the majority of our experience. We have been collecting data for already over six years. We have six observational studies running. So we're working with real world evidence. For example, in degenerative disease, we have patients that have been that have completed or that we still are following up, more than 1,100 patients, shoulders conditions more over than 800 patients, knee conditions over than 600 patients. So our database is very robust, and we are we have outcomes being measured in a standardized way with protocols. So we're not only looking on pain reduction, we're also looking on functionality and quality of life improvements. And the idea is that if you're gonna be deciding to treat a condition, it's very important that you are gonna be doing a follow-up and that you're gonna be collecting those outcomes and those results, because that's gonna be telling that's what it's gonna be telling you that the product that you're using is a good product and that the protocol that you're using is a good protocol. At the end, if you don't measure results, like then you don't have the evidence to prove it. So in inflammatory conditions and actually also in autoimmune conditions where we have or in in chronic diseases where we have low rate chronic inflammation, mesenchymal stem cells is also very useful because of the immune modulation that they that they have, that the capacity of immunomodulation and anti-inflammatory signaling that they can have with their secret. So we also have experience treating autoimmune conditions. The ones that we see very good results is in multiple sclerosis, in gastrointestinal autoimmune conditions, chronic colitis ulcerativa, ulcerative ulcerative colitis and Crohn disease, in rheumatoithritis. We see very good results with autoimmune conditions, but basically, any inflammatory condition can respond very well as the new the terminology that is that it's being very active using is inflammation, as how low chronic inflammation is the cause of chronic diseases and is the cause of accelerating aging, and stem cells have the capability to modulate that inflammation and modulate the immune system. In conditions that I don't think they perform very well is when there is structural like a mechanical problem, a structurally, structurally irreversible situation, a biologically, very hostile or advanced condition. So, for example, a complete tendon rupture when actually that what you require is actually surgery. Very advanced bone-to-bone diseases, major deformity, severe instability, active infection, out control, outimmune activity, out control, like out-of-control systemic inflammation, and especially what for me is most important is unrealistic expectations of the patient. So that's and definitely cancer. Like stay away, stay away of those patients. They're not good, so all of these patients are not good candidates for for regenerative medicine.

SPEAKER_00 30:07

Gotcha, gotcha, thanks so much. You know, it's really impressive. And it speaks volumes to the fact that you have really doubled down on data control and data collection and and really making sure that this is the right way to be able to treat your patients. And if the protocol isn't giving you the outcomes, I I know you've shared with me that you the that you've changed your protocols based on your real-world data collection. So that's that really is important, and then that's part of the reason that we need to all be collecting data. It's it's really quite devastating how much data loss is happening in this country. We're losing so much data because we don't have robust ways, we don't have robust incentives to be able to collect data for all of our patients that we're treating. Uh it's an extra step. It's an added cost. It's it's all the and it's the right thing to do. So I I would just urge everyone who's on the call, if you're doing orthobiologics, please, please, please, no matter what, you know, pen and paper, collect your data, follow those patients, get those outcomes, the the patient-reported outcomes, the validated outcomes uh is really important. But, you know, Dr. Hobbit, we still have more questions. And I know we talked a little bit about host biology. Now, do you think that host biology is as important as you know, the the treatment? Are we underestimating how much optimization matters before we're delivering these therapies?

SPEAKER_01 31:51

So, yeah, I think that it's very underestimated, very underestimated. And I often explain to our patients the concept of a fertile soil. Like you can have the best seed, in this case, the product, biological products, but if the soil is inflammed, depleted, toxic, metabolically unhealthy, or mechanically unstable, the seed will not express their full potential and you're not gonna be able to get the full potential of what you can get from biologics. So in regenerative medicine, the cells are part of the signal, but the host environment determines how that signal is gonna be received, interpreted, and translated into repair. So if patients are inflammed, with insulin resistance, sleep deprived, nutrition deficiencies, hormonally dysregulated, metabolic unhealthy, smoking, under-recovery, like all of that is going to affect your results with the biological products. So it's very important that we prepare the patient, and this is with optimized like with optimization therapies like creotherapy or anything that it can address low chronic inflammation, ozotherapy, plasma exchange, cryotherapy, hyperbaric, IV drips, so and also nutrition, lifestyle changes. So lifestyle medicine is very important and functional medicine is very important, and all of that they complement very good with stem cells. And something something that we miss and that it's also like missed a lot is that after after stem cells, it's a must to have like rehabilitation, physical therapy, because that signal is very that mechanistic signal is very important to stimulate the cells and the repair or the it's done in a in an organized control way. And if you have a lack of that stimulus, you're not gonna get everything that you can get from the capabilities of the stem cells. So, yeah, optimization therapies and lifestyle medicine, it's like a must, and never forget like include them in your practice and get educated on this and and and prepare the patient for receiving stem cells.

SPEAKER_00 34:21

It's so important. I was just watching a I think it was actually a show. It was a late night show, and it was the Huberman lab, and Andrew Huberman was talking about the cheapest, most effective thing that you can do is make sure that you have adequate sleep. And so he is like, out of all the things that he talks about, and he talks about a lot of things, the number one change that will be positively impacting your biology, your wellness, all of the pieces of the puzzle is sleep. And I think we really, really I don't know if we've just been trained to ignore it as physicians, and or we don't really we maybe haven't learned or been taught the massive impact on regenerative and restorative sleep. So for all of you out there, please counsel your patients to really have that circadian rhythm reset with sunlight in your eye at low level every day, uh, because what that does is it sets your circadian rhythm for to be sleepy 16 hours later, right? And this the circadian rhythm is so important because it's during sleep that all your cellular repair happens. So if you're not sleeping, if you're not getting good regenerative restorative sleep, then you can put the best stem cells in the world in. But if they can't do their job because of this biology, this host biology, I think it's that's one of the cheapest things. That's what I tell all of my patients is we really focus on sleep because it's really cheap, right? And it's something that uh everyone can work on. So we have a couple more questions. So if US regulations were to loosen and or evolve, which they are, what does responsible adoption look like for physicians who want to do this the right way?

SPEAKER_01 36:20

Yeah, so education of the physician is very important. So physicians are colleagues to understand that offering every cell product or every biologic available to every diagnosis is like a wrong direction. We have to very well define indications, we have to have written protocols, we have to have a physician trainings, the proper selection of the patient, standardized manufacturing, and also very important adverse events reporting and outcome tracking. So if we're able to have all of that and if we're able to be like ethical and responsible, that we have a big responsibility as physicians, we can make this field grow in a very responsible way that is gonna be at the end protecting our patients. So it's having the honest conversation with our patients, who is a good candidate, who's not a good candidate, that right the correct selection of the patient and having those honest conversations with our patients, it's very important. This is not a miracle cure, this is a very potent product that we can get a lot of out of it and a lot of good results, but we also have to be very careful because all the biologics are different, and how we manufacture it, manufacture the product, we're gonna be having many different products because the process, in this case, the process, is the product. So we have to know the process so that we can actually know with what product we're working and what can we expect from that product.

SPEAKER_00 38:07

Great, yeah. It's so good, and and I am really the as you probably remember and know, like this is on the forefront of my mind as the the regulations are listening in state by state and it's happening quickly, but it also puts physicians at risk if you don't understand every piece that needs to be done properly to be to keep yourself out of trouble. Um, I definitely have uh talked with some legal representation and the the recommendation is is as long as you're following the the state law to the T, the most the most likely uh chance is that you're gonna be clean, right? But it's still not federally accepted. So we there's still some gray zones. So I I think uh having those honest conversations with your patients, having the the ability to say, yeah, this isn't right for you because your biology. I know for me, my all of my patients undergo a biologic optimization ahead of time before we do any kind of injections. And they kind of sometimes get a little annoyed that I'm asking about their sleep and their stress and putting them on an anti-inflammatory diet and checking their, you know, blood glucose and all of these things. And I said, listen, hey, you know, if you are looking to have the optimal outcome, I need you to be the optimal humans. And unfortunately, I always tell them that they're now the pharmacy because we gotta make their tissue and their blood and their platelets and and all of their proteins and inflammatory markers the best that we can make it. Because at this time frame, we're not using stem cells on an on a widespread basis. I mean, this may this may change in six months, and we may we we may be coming back in six months and being like, wow, okay, now that things are very different in the United States, where do we go now? But for right now, we're still, I'm still really interested in how do we do this responsibly, how do we do this the right way, staying safe not only for our patients and for our license? So I think there's a couple of questions out here, so we're we'll we'll get to that. But I I do wonder how this is gonna look. If you if you had, you know, the a magic wand and you could make this happen responsibly, what does that future look like for patients?

SPEAKER_01 40:45

So what it's happening in the US is actually very interesting. That state changes is very, it's very interesting. What's happening in Florida, Texas, and Utah, and I'm I'm guess I guess that more states are gonna be adding up. And I'm very happy about it. I'm very happy because this is the way that regenerative medicine is gonna grow, the field is gonna grow, the awareness, it's growing, the research it's growing. There's very like it's uh it's it's an area that has in the last 10 years that I've been in the field, I can see how the research activity has like spike and the research interest is taking place. So, as you were saying when you started the conversation, is that you see that orthobiologics is gonna be in five years, the first approach. I actually think that probably is gonna be happening sooner than five years. And I hope, well, we need to like if we want this field to grow and that there's not a lot of scepticism, we have to do it the right way because we cannot overclaim, we cannot approach regenerative medicine as a marketing language. It has to be data-driven, it has to be results, it has to be proven to be to actually really say to protect the field and to protect the biologics and to protect the the making this in a responsible way. So actually, it's gonna depend on us. It's going to depend on how we do this, because if we overclaim, we're gonna be just pushing for more strict regulations to come out. And if we do it in a responsible way and we're showing results and we're showing the data, regulatory entities probably are gonna lose and solve a little bit more and help us to be able to that countries can continue advancing in this field. So we are a very important role in this, in this, to be able to grow it in a responsible way or to or to ruin the field.

SPEAKER_00 42:55

Yeah, so basically it's up to us to do either a good job or a bad job, right? So here's where we say, what is the next step, right? So ultimately, how do we make orthobiologics first-line treatment for our patients? And uh so the next step is, you know, getting that practice launched. So this is our practice launch system where we have the orthobiologic knowledge, we attract the right patients, the properly selected patients. How do we create this cash-based business that's outside insurance-driven care? How do we talk about this in a manner that patients understand our understanding what can be done, what cannot be done, and then putting it all together for success. And so we really do need to do all of these in step. So if you want the fast track, I do have a little quiz for you all. How ready are you to get going? Evaluating your capital, your clinical confidence, your workflow, and really, are you ready to go? Are you out of the gates? Or, you know, are you kind of just thinking about this? So please, please, please scan this code, take the quiz, and then we're gonna go over to QA. So thank you so much, Carolyn Halbert, Dr. Halbert from BioAccelerator. I do there are some questions. I did want to put your your website in the chat. This is the Bioaccelerator website. Uh, there's definitely more information. There is a question, and I'm I I'm curious about this as well. So is there a need or a role for HLA testing for allogenic therapies? Uh, can you speak a little bit about the the confusion or what is required for that?

SPEAKER_01 44:54

So, no, it's not required because stem cells, stem cells they don't express HLA proteins at one and two. So it's what it's called immunoprivilege. They're not detected by the immune system, so they're not attacked, destroyed, or eliminated from the from the body. How they work is that they are they work through the secretone, so through releasing all of the cytokines, growth factors, anti-inflammatory cytokines, and micro RNAs and extracellular vesicles. So they work with because of what they release and what they simulate in the host, in the patient. They don't engraft, they don't change into, they don't become a specialized cell, so they don't become cartilage, they don't become bone in the body, so they work only because of what they're releasing, what they're simulating in the patient. And what they're stimulating in the patient is the patient's own stem cells, it's controlling inflammation, it's controlling the immune system, immunity modulating, so that the so that the patient's capacity of repair and recovery is simulated. So there's no risk of rejection at all. So they are good for allogenic use. Since what we are expecting is not engrafment, and it's not that they become in a specialized cell, is that they stay in the in the stem cell profile and that they release all of this, all of this secretome and all of this signaling and messaging information.

SPEAKER_00 46:28

Gotcha, gotcha. All right, so those are some really good questions. Let's see. I think we have let me see where we are. All right, we have some more questions, and so you know, from a selection process, where would you select maybe fat or a bone marrow concentrate for your patients?

SPEAKER_01 46:55

So we don't do those, we don't use those products, and we are only using white and jelly allergenic products. But I will say that if you have a healthy patient, a young patient with not a lot of chronic inflammation in their body, not being exposed to a lot of toxic and environmental toxins, like they're not smokers, they don't drink, so that they really take good care of themselves, those patients can be a good source of their own stem cells. But if the if they are inflamed and their regenerative capacity or recovery capacity is declined, I will prefer to use another products that are standardized and and off the shell and available to use and safe.

SPEAKER_00 47:43

Yeah, yeah. I did want to invite everybody to a live event that we're putting on. This is an event in June 5 through 7, so it is definitely filling up fast. And this is a three-day immersive event to engineer your predictable cash pay practice. So if you're interested, please don't hesitate, scan that QR code. And this is an immersive event, not only to plan out your 90-day escape from your insurance-based practice, but to really plan out your cash-based orthobiologic practice and leave the event with your step-by-step plan to move forward, not only with ultrasound training, but marketing and the nuts and bolts of the cash-based practice. So I did want to invite you that we are putting this on three-day immersive event, June 5 through 7. So please scan the QR code and uh I would love to have you there. We do have, let's see here, we have a couple more questions, and I always have questions. So, you know, as we go forward, I think that can you tell me the difference? Let's just pretend that you could ship yourselves or or would ship yourselves to the United States. Can you tell me the difference of what you would potentially ship versus, you know, how do I know when I get when a company ships me a little vial, what's in it? How do I know? How do I look? Oh, like how do I keep myself and my patients safe? And and and what maybe are you doing differently at Bioaccelerator? I know you don't ship because you have that direct manufacturing release and application of those viably, the viability tested cells for your patients. But if you were to ship, let's just pretend and say, how do I how do I kind of wrap my head around if I do have a good product or not?

SPEAKER_01 49:54

So let's say the manufacturing company, let's say that it has an amazing product. And the product, of course, depends on the process of manufacturing. So let's say that it's a very good product process. What happens after when the product leaves this infrastructure? Questions that doctors have to do is how is the the change of custody? How is the the code change? Has it been respected? Like has been like how long how long has passed since the product left the company and how long it took to come into the facility that it's gonna be receiving. And if those doctors are being well trained to how to manipulate the product when they receive it and how to storage, how many days they can store it, in what conditions they have to keep it. So all of these are like all the questions and training that doctors must have. And then they have to be also they have to also know how to taw the product, and that in the towing process you're not losing viability of the cells. So I guess that the company has to teach you, give you protocols, give you processes and procedures, train you very well, and that they can prove you and show you that they did all of this testing, that they did the testing of what happens to the product when they leave the facility, what happens during that transportation. They have to be able to show all of those results, and they have to be able to prove that if they send a product and it takes four hours of transportation with what temperature and what temperatures need to be manipulated, so when the product gets to the clinic, it really has what they're promising that it's gonna have. So they have to be able to prove all of this, and they have to do all these essays and research, and they have to provide all of these results to the facility. Then something that I think that it's very important is the manipulation of the product by the doctor. So it's just not if you're having a product that is sterile, you have to manipulate the product in sterile conditions. You just cannot manipulate the product anywhere, like with no control, with no sterility, because you have the risk of contaminating the product. So it's not only that you lose viability, it's also that you can contaminate the product and then you can have like a complication with a patient causing an infection. So I will say that at least minimum, the doctor in the office should have a flow cabin where the manipulation of the product is being under control, sterile conditions, that you're not gonna be contaminating your product, and that it's still gonna be safe to apply. So, so it's where all this training and all of this comes, it's very important because it's just not a bio, get it and inject it, it's much more. It's a biological product, it's have live cells if you really want to see an effect and see a result. We are exploring the option of sending our products with selected clinics and selected specialists. We can train them and that we can actually help them build this area that they can receive storage and manipulate the product in a sterile conditions so that the product at the time of injection is viable or in cases of exosomes and secretum is stable and that also is continue being sterile. So we're we're exploring those options, and that will be like coming also with our protocols, our SOPs of how to handle, manipulate, control, storage, prepare, taught the product in a correct way.

SPEAKER_00 53:50

Awesome. So I think leaving everybody uh today with tell me if this is proper. So if you have been taught to thaw it in your hand for five minutes, that's probably not best practices. Is that correct?

SPEAKER_01 54:08

That's not best practice because there you cannot control the temperature, and they're so they sell devices that you can thaw in a control way that you're not going to affect the temperature changes that is going to affect your product. So it's just not towing on your hands because that way you cannot actually be measuring how the temperature is recovering and how the changes of temperature are being done and how you can you have to control them.

SPEAKER_00 54:36

So yeah, yeah, I think that's probably the best rule of thumb is if you got taught to just hold it in your hand and warm it up, that's probably uh the first sign that you need to find more rigorous company to be able to partner with. So Dr. Halpert, a little known fact, and so so, so, so impressive. English is not your first language, correct?

SPEAKER_01 55:03

No, it's not.

SPEAKER_00 55:04

Sorry for my English and oh my gosh, this is my favorite fact because I would have no idea that that is true, that it's amazing, and I am 100% jealous that uh you have such you know a handle on the very, very, very scientifically rigorous, you know, language and communication. And and and it's you're you're an impeccable communicator and speaker. So I I love I love that fact about uh you is uh that I would never know unless you told me that. So now I've I've shared your little secret. That's that's pulling back the curtain and and sharing it with all our friends.

SPEAKER_01 55:38

Oh, thank you because actually you're making me feel better. I'm always growing hard on myself with my English. So thank you. It makes me feel much better.

SPEAKER_00 55:45

Oh my gosh, yeah. So thank you so much for coming. Everyone else, thank you so much for being a part of the conversations in regenerative medicine. I appreciate all of the things and all of the information that you shared with us today. And again, this is Dr. Carolyn Halpert from BioAccelerator B I O X, C-E-L-L-E-R-A-T-O-R dot com. And uh please, if you have the opportunity, uh connect with and and really start to get smart about the culture expanded because this is coming, this is coming to a state near you very soon. And so let's let's be really smart and responsible about how we add culture expanded cells to our acumen that we can share with our patients. So, again, thanks so much. Take care, good night, uh, and we'll see you in two weeks for the next conversation in regenerative medicine.

SPEAKER_01 56:44

Thank you.