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Keep Moving Pod Transcripts

Episode 9: The Regenerative Regulatory Landscape

​Welcome to the Keep Moving Pod with Dr. Sam Oltman, because the only way to keep moving is to keep moving. Hi there, Dr. Sam Oltman here, naturopathic physician, regenerative medicine specialist, musculoskeletal ultrasound expert, and foot health guru on the Keep Moving Pod, talking you about health and all things related to keeping you moving.

All right, hello, welcome everyone to the next episode of the Keep Moving Pod. Today we're going to talk about the regulatory landscape in regenerative medicine. Please excuse my voice. My son Geo just started going to daycare and the whole family has been sick all weekend. So just getting over a little viral bug here, but drinking tea and trying to rest and get better.

So there are a lot of questions and a lot of kind of murky water when it comes to both FDA and FTC regulation of regenerative medicine, PRP, stem cell therapy, and the whole field. So the goal of this podcast episode is going to be to kind of more clearly define what is and isn't allowed, what we do specifically at Cascade Regenerative Medicine, and sort of clear up some of the common questions we see, such as, is PRP FDA approved? So to start, when we just talk about the FDA's role in genera, so FDA stands for the Food and Drug Administration, they're responsible for the approval of drugs in this country. Now already you can see that this definition right has some limits. Generally the FDA is what is you know approving you know your cholesterol medication and you know your anti -inflammatories and you know pharmaceuticals. Now when we they also regulate medical devices. So that would be you know things used in surgery for example therapeutic devices imaging devices and what they do not do is the FDA does not regulate the practice of medicine and so for our purposes here you can think of the FDA as the people who approve drugs and medical devices right.

And then the next question you may be already thinking is, okay, well, what is regenerative medicine? Classified as, because it's certainly not a drug in the classic way that we think about it. And really the kind of overarching question of everything we're gonna talk about is with orthobiologics, meaning biologics from your own body, autologous orthobiologic therapy, right? So, biologic tissue from your own body, is that a drug? I think most people's knee -jerk reaction is, well, no. We'll get into how that's defined, but using your own tissue the same day for a medical treatment that's all done in office is not under the purview of FDA Regulation. 

So PRP, platelet -rich plasma, the treatment we do a lot of at Cascade Regenerative Medicine. It's a product made from your own blood that has been down, concentrated, and the platelet portion extracted in order to use as a treatment for a variety of different conditions. Under the FDA, this process and this product is not subject to approval. Blood products like PRP are exempt from regulation. So PRP is not FDA approved, but it never will be because it doesn't fit under the purview of their regulatory framework. And so it's an important distinction because a lot of times people will not know that the FDA doesn't approve certain things. So, To say it's not FDA approved doesn't mean that it's trying to get FDA approved that it's pending right that it that it has been that it's been you know attempted to get approval and rejected it is not FDA approved because it's outside of their scope as a regulatory body so not subject to approval there's the code for the code for federal regulation number 21 spells this out blood products are exempt so PRP totally on the up and up regulatory wise it is exempt as a same day blood product and as we'll talk about more too there there are FDA approved PRP production units but that's different than than they're approving the medical device they're not approving the therapy.

Okay, bone marrow and fat, bone marrow and fat are the two legitimate ways of getting stem cells from your own body. Bone marrow is right from your own body autologous. Bone marrow used in different orthopedic conditions is what's considered in the FDA's language homologous, which means it's used for the same purpose as the original tissue. As we'll talk about here in a second, it also qualifies them in the same qualification that MFAT does. adipose drives stem cells, which is what we do at cascade regenerative medicine more precisely, because we don't call it that more precisely, it is called MFAT, which is micro fragmented adipose tissue. That is not homologous. Because the fat ends up doing something in the treatment that is different from the original function of the fat tissue, although I think that definition is somewhat dubious. But it ultimately doesn't matter, because both bone marrow and MFAT fit under what's called the same day surgical exemption. And what that says is using a patient's own tissue that is minimally manipulated and used in the same office visit on the same day, in the same location, is not under the FDA's purview to approve. It's not a drug. So those are kind of the three main orthobiologics kind of spelled out pretty clearly. And they all there's different sort of codes that they that they fall under the PRPs in a different sort of exemption than bone marrow and fat, but they all three follow this basic principle of they're not FDA approved because they're not drugs.

And I think one of the things that gets confusing even for doctors is like the FDA's job isn't to approve medicine or I should say the practice of medicine. They approve drugs in medical devices only. So the idea that something is not FDA approved doesn't really mean much as sort of if someone saying like oh well you shouldn't get PRP because it's not FDA approved. They just the people saying that don't understand the purpose of the FDA or what PRP is right. It's not a drug neither is MFAT. So as an aside as I mentioned before both the PRP that we make at Cascade Regenerative Medicine and the MFAT all use FDA approved devices for their making right. So for the production and the creation of these products the products themselves because they're not drugs are not FDA approved and never will be. However, the processes and devices made are you the devices used to make the product are FDA approved. What's what's required of these things is clean and sterile processing. So sterile equipment, sterile hood, being able to do things, clean handling of tissue products. So as I said from the FDA's website, the FDA and I quote, the FDA does not regulate the practice of medicine, medical services, the price or availability of medical products, and whether they are reimbursed by health insurance or Medicare. And so the FDA themselves have a pretty clear line as far as, you know, what is approvable and not right. So something not being FDA approved doesn't mean that it's not legitimate or or that it's has been disapproved of right. It's just outside of their scope to put this in a context right. So the FDA doesn't approve surgeries, right. So that meniscus surgery that you may have had, that's not an FDA approved surgery. They approve the hardware and the devices used in surgeries if hardware is used, right, but they don't regulate surgical practice, right. And so this is very similar. And it's a little bit of a of a sleight of hand or a little bit of misleading rhetoric when people talk about it. And people talk about regenerative medicine not being FDA approved. Again, we're not using drugs. They don't go through drug approval. So that's all of your autologous orthobiologic summary. Obviously, the bottom line is if it's done using correct processes, correct devices from your own body on the same day in the same location, which is everything we do at Cascade Regenerative Medicine, then it's all good. It's all the practice of medicine that is between you, that is between me and my patient as far as what we decide to do and getting the required informed consent to do so.

Now, what can make it confusing is if you peruse the FDA website, there's an article from a few years ago, I believe 2019, that says on the FDA website that all regenerative therapies are unapproved for orthopedic and musculoskeletal applications. So, they're saying that all of these different therapies are unapproved, but then they're also saying that they're not under their purview to approve. So that's where some of it can get confusing I think part of the confusion which which you know that article or that that piece on the website was written a few years ago I think what has done What's happened the last few years is a much more precise definition of? Essentially, what is a drug and what's not a drug? Because I think when that was written like I said in 2019 maybe 2018 There was this idea that PRP for example should be regulated as though. It is a drug And we can you know it's it's obviously not a drug It's Multi -variant it's constantly changing It's made from very very simple Physically simple Processes from your own body right it's not manufactured It's not a single molecule It just doesn't have the same The same characteristics as pharmaceutical drugs and You know the other big Piece of this right is this sort of I mentioned this in a previous podcast The idea of the synthetic fallacy right that the only real medicine is Pharmaceuticals right which is a fallacy. It's a bias toward drugs That we can see kind of being transferred into other domains like this so people say oh well You're injecting something and it helps people that must be a drug No incorrect So that's all of your autologous orthobiologics Which is which is everything we do at cascade of agenda medicine now? What do you what do you what you also see out in the world out in this?

Regenerative medicine landscape is a lot of talk about umbilical cord or Fetal tissue products amniotic Um, the, the three kind of main terms you would hear umbilical, amniotic, and fetal or Wharton's jelly, stuff like that. All of those are fundamentally different for multiple reasons. So we'll get into that right now. So those fetal tissue products are different, fundamentally different than everything I just went over so far that are autologous from your own body. Because they come from someone else and they are sterilized, processed, freeze dried, packaged by a company who then sells that product to a provider. It is a drug product. Now you may quibble with that definition, but it is undeniably distinct from the process of say PRP or MFAT, where we are doing a simple procedure to minimally. Manipulate your body's own tissue to redirect it into a specific location versus a third -party company going through extreme lengths to produce a product That they then put into vials ship Cell and then are you know sort of reconstituted and and and sold to the patient Those are products right those aren't autologous. They aren't done the same day They aren't done in the same location. They're coming from someone else, right? So just from the start we can see that that makes a very very large difference in terms of the dynamic and the definition of the product themselves these things Because They fit a different definition like I just outlined. These are not legal It has made it has been made quite Explicit at this point from the FDA There are FDA approved umbilical derived products for very specific Blood diseases that Really have no overlap with with orthopedics or with regenerative medicine clinics, so the The clinics who you see who are using and selling Umbilical cord amniotic Wharton's jelly fetal tissue products are doing so illegally and they continue to do so Simply through a lack of enforcement right the FDA only has so much enforcement capacity and they go after the Biggest offenders first and there's some examples of lawsuits that clinics have lost and when you Look at what they were claiming what they did and compare it to for example what? I do at Cascadia Regenerative Medicine, it's very easy to see the difference. We're not doing the same thing. We're only very vaguely in the same field. And it becomes very easy to distinguish to the discerning eye. Outside of, frankly, regulatory concerns, just as an aside here, umbilical and amniotic products from a quality assurance perspective simply do not have living cells inside them. So even if they were legal, the claims that you're getting live cells, that they're better or equal to the autologous therapies that we do, none of that's backed up by any good evidence. They are vials of tissue that used to be alive that no longer contain anything viable. Again, that's sort of a moot point because they're illegal now anyway. Now again, what I'm doing right now is spelling out the letter of the law. We could, you know, there could be some debate as to whether they should be legal or not. I think it's good that they are at this point. I don't think, I think the theory is way ahead of the practice in terms of these products, meaning it sounds really good. Everyone loves the idea, this idea of quote unquote young stem cells, right? Everyone's told, oh, you're old. You need stem cells from a baby injected into your knee that has this sort of sci -fi romanticism built into it. And you know, if only we could just sort of like have production facilities of stem cells and just bathe ourselves, inject our joints, you know, IV them, like kind of just get infused with these young life -giving cells, that seems to be more appealing theoretically. But the actual, again, even if that were the case, which I can see some of the logic in there, but we're very, very far away from that being reality. There's so many issues with medically speaking from the perspective of something that is not yours and implanting it into your body. But even if it, I mean, that theory is not at all what you're actually getting with the clinic selling them to you. And so that's just the theory being way ahead of the practice. The actual thing that's happening, you know, when people are being sold these things is that they're getting a vial of at best some kind of fancy growth factors, you know, some dehydrated tissue and being sold something that they're simply not getting. So, it might be, you know, by the end of my career, where the field is headed, it may be the thing that we are doing more regularly down the road, but we're simply not there. And I don't think we're really even close at this point to getting there. So, that's umbilical. If you see anyone selling that stuff or offering it to you, walk the other direction. They're not legit. And there's, like I said, regulatory reasons why, and there's sort of scientific medical reasons why.

So, okay. And then next subject here we're going to get into is the FTC. So FTC is the Federal Trade Commission, and they regulate advertising claims. So what we just went over was the FDA approving drugs. They do not approve PRP and MFAT because PRP and MFAT are not drugs. They do approve, or they do have under their purview, umbilical products, umbilical products are not approved, they're illegal, and they're simply ineffective. Now the other piece of the regulatory landscape is the FTC. They don't have anything to do with drug approval or medicine per se, they're regulating claims. So claims about curing diseases, how you advertise in this area is equally, if not more, fraught than what we just went over. So the main issue, as far as the FTC is concerned, is primarily this term stem cell therapy. Stem cell therapy has been defined as a very specific set of therapies used in cancer and post chemotherapy treatments for blood disorders. When you get a bone marrow transplant after having leukemia, that is stem cell therapy. Anything else outside of that definition is not stem cell therapy. Now again, what we do at Cascade Regenerative Medicine is called MFAT. Nowhere on our website does it say stem cell therapy. I believe I've already used the term earlier. The issue now with me and my practice and my patients is that people, the term stem cell therapy is now in common parlance. And so people will use the term and we as providers and regenerative medicine experts have to sort of use it in the sort of casual sense while being clear with people of the more specific thing that we're doing. So the term stem cell therapy had been hijacked as sort of derogatory, but it has been co -opted because the term is recognizable. The term stem cell is sexy. We all, there's a fight over stem cell research during the Bush administration. It's very much in the news. There's this allure to stem cells as being the medical fountain of youth. And so the term itself has some gravitas. And it's become recognizable. It's difficult to discuss the subject without using the term at all because of its popularization. The people like Joe Rogan and other similar platforms where, you know, again, it's sort of this feed forward cycle where even if you're trying to be more precise, you're also trying to speak the language that people will recognize and it ends up, people just talk about stem cell therapy, this stem cell therapy, that. And so the FTC does not like any of that. if you see stem cell therapy being advertised right you and it's not for cancer or for blood disorders if you're seeing stem cell therapy for a knee thing a knee disease knee osteoarthritis you know that that clinic is not reputable automatically okay now again that doesn't necessarily mean that they are doing bad medicine although I would I would I would find it hard to make that distinction of if someone's really pushing the bounds they either don't know which is a red flag or they do know when they're pushing it anyway which is also a red flag so what we do at cascade regenerative medicine as I've said before is m fat m fat is a commonly known acronym in the medical realm in this field it's an acronym m f a t it stands for micro fragmented adipose tissue nowhere on our website does it say stem cell therapy because that's not what we do we do the m fat procedure using FDA approved medical devices which is allowed under the same day surgical exemption now we can talk about what m fat is in a more sort of scientific or literal sense and m fat is a mix of collagen matrix fat cells and mesenchymal stem cells or mesenchymal signaling cells or pluripotent signaling cells there's different terminology right which is one of the things people refer to and they say stem cells but we can be you know a little bit more precise the term or the acronym MSC has been used a lot for the last 10 plus years as an acronym for mesenchymal stem cells. And so the new sort of little inside baseball thing is to take the acronym MSCs. And instead of calling or instead of referring to that as mesenchymal stem cells, use a different set of words that still is MSC, mesenchymal signaling cells, for example. So that's what MFAT is. It's not stem cell therapy. And we don't advertise that because it's not. Also, importantly, from the FTC's perspective is making claims to specific diseases. So MFAT and PRP are not approved or proven to treat any orthopedic disease. And we don't claim that it does. What we do at cascade regenerative medicine is that we do non -surgical orthopedic medicine And that we address the gap between physical therapy and surgery We don't advertise specific claims The the specific use of therapies for conditions is discussed between me and my patients within the confines of a doctor -patient relationship and qualifies under the practice of medicine Where the off -label use of drugs and procedures happens routinely After a fully informed consent is reached questions are asked and everyone's and everyone is on the same page there are lots of examples and everyday uses of off -label uses of FDA approved Of FDA approved things so You Can do off -label use of medical devices, right? So the device is approved by the FDA for a certain thing and you can use that device to do a different thing That's an off -label use its FDA approved device, but it's not FDA approved for the thing you're using it for There's lots of drugs that are All right. I mentioned surgery before surgeries this wouldn't necessarily be off -label right but surgery or any surgery is not FDA approved And so that's just to put things in perspective. It's like yeah PRP is not approved near it. Neither is your knee arthroscopy The devices used in both are approved or not approved but not the procedure itself because they don't improve the practice of medicine Lots of off -label use of drugs gabapentin is used off -label all the time SSRIs or antidepressants are used off -label all the time meaning they were approved for one condition and used for many other conditions Other than the condition they were approved for Propranolol a beta blocker is used for performance anxiety like stanley fright, which propranolol is FDA approved. It's not approved for that condition, but it's used for it all the time. Viagra. Viagra is FDA approved. It's used off label for females. It's only approved in men, right, but females can legally take it. Doctors can legally prescribe it. Off -label use is not illegal and not really a problem because it fits within the purview of the doctor -patient relationship and it's the practice of medicine. It is not something that the FDA or even the FTC, depending on what you're advertising, can regulate at all. So making claims, you know, I'm very proud of our website and so hopefully when people see our website they can discern a difference in in tenor, in language and just overall vibes with with our cascade regenerative medicine website versus other other establishments and clinics in the same area and one of the biggest issues in this whole field of regenerative medicine is over promising and over hyping. So PRP and MFAT are good medicines. They fit within the context of conventionally available medicine like cortisone injections, physical therapy and surgery and they are often a good alternative to those things but they are not magic, they're not a cure -all, they are not the fountain of youth and it is up to you and your doctor, up to me and my patient to decide with fully all of the alternatives, risks and questions associated with the procedure, what the best thing is for each individual patient and so I'm really someone who you know like many health fads that you can you know from big to small you know regenerative medicine has been memified a lot into you know kind of getting out ahead of its skis and you know that's brought in some bad actors it's led to some bad outcomes for people because they thought they were getting a cure and they got a substandard treatment because of the person delivering it wasn't doing it correctly and so my biggest or one of my biggest objectives with patients is as I've said other times and in many other contexts is transparency. Working in alternative medicine puts an extra level of responsibility on me to be as scrupulous and conscientious as I can possibly be in allowing people the a really fully informed consent and understanding and helping them understand where these alternative treatments fit into the bigger picture and by not presenting them as a cure -all by being realistic what we get is patients who are well cared for and patients who are very happy with the level of care they get and the results that we get. It's the same level of transparency that we bring to all of our patient interactions to all of our pricing discussions Um, we bring it to the regulatory landscape and the discussion of that as well. And so unfortunately there's not a super simple answer. Um, these last 30 minutes have been, you know, the, the, the more in -depth, um, kind of full answer. Um, but it is important to know, and I know, you know, um, not every patient necessarily wants to know this level of detail, but a lot of people ask. These kinds of questions, I think it's important to have a place like this podcast where we can fully get into the, um, ins and outs of, of the, you know, is what you do approved is what you do legal. So what we do at cascade, regenerative medicine is legal, safe, and reputable. The science, um, is always going to be developing as we've talked about in previous podcasts, um, I would argue that while the treatments like PRP and M fat have not been proven beyond the shadow of a doubt to help with specific orthopedic conditions, uh, neither has most things in orthopedic medicine. Um, right. There's 700 ,000 meniscus surgeries done every year in this country. They're unproven surgeries. And so it's not too, um, muddy the waters, but it is say that there's a double standard. And so what we do is legal, safe, and reputable, the details matter and our commitment to offering the most advanced therapies possible while staying within the regulatory bounds and being able to articulate them to patients should tell you all that you need to know about how we operate. We take this stuff very seriously. And if you're considering treatment from someone who cannot explain these points succinctly, please think again, knowing where the line is, is a part of being an expert in this field. So thank you for listening to everyone. I hope that helps and clears up the confusion. I think as a patient consumer, it is very confusing. Most doctors are confused about the regulatory landscape in this field. And so don't feel like it's just over your head. It's it's a confusing area. But do know that there are some things you can look out for as a patient. If your gut is telling you something's off at a particular provider or the particular website, it probably is and there are things you can look at, like the over promising of results, the use of certain terms, saying something is FDA approved, when in fact, you know that it's not. And so you can always look at our website as what I think is a really good example of Stating matter -of -factly, the things that we do while not over -promising and ultimately discussing the pros and cons of each treatment with you as a patient is really the only way to know for sure if any of these things will be helpful for you. Thanks everyone for listening. 

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