The regenerative medicine market is projected to reach $169 billion by 2034. For healthcare and wellness founders, the demand is undeniable. Patients are actively seeking alternatives to surgery and pharmaceuticals to manage pain and inflammation.
But for the practitioner, this opportunity comes with a paralyzed fear: compliance.
The industry is rife with misinformation, "bad apples," and vague regulations that leave honest providers terrified of marketing their services for fear of losing their license or getting banned from Google.
In this episode of Grow Smarter, Andrew sits down with Chuck Meeker, JD, PhD, co-founder of Hyagen Medical. With a unique background as both a molecular biologist and an attorney, Chuck offers the definitive playbook on how to bridge the gap between cutting-edge science and strict legal compliance.
They break down why most "stem cell" marketing is biologically inaccurate (and therefore illegal), how to properly vet your supply chain, and the "Delivery Truck" analogy—a simple, powerful framework that allows you to market regenerative therapies confidently, ethically, and effectively.
The biggest mistake providers make is claiming that stem cells "turn into" new tissue (like cartilage or bone) once injected. While embryonic stem cells do this in a fetus, the allogeneic (birth tissue) stem cells used in therapy function differently.
Chuck explains that biologically, these cells act as signalers, not builders. Marketing them as "seeds" that grow new tissue is not only biologically inaccurate—it’s a non-compliant medical claim that puts your practice at risk.
If stem cells aren't building blocks, what are they? Chuck introduces the "Delivery Truck" analogy, the golden key to compliant marketing.
The Truck: The stem cell itself is just a carrier vehicle.
The Cargo: The truck is delivering a portfolio of natural growth factors and cytokines.
The Hero: The patient’s body.
The Compliant Message: "Stem cells are nature's couriers. They deliver natural biological growth factors and cytokines that signal your body’s own repair mechanisms to wake up and get to work." This shifts the focus from the product curing the patient to the patient’s body healing itself.
To stay on the right side of the FDA, your therapy must fall under Homologous Use. This means the product must perform the same function in the recipient as it did in the donor.
Because stem cells in the umbilical cord function as signaling vehicles for the fetus, using them to deliver signals in an adult patient is considered homologous use. This definition is critical for your legal safety and should be the foundation of your marketing language.
Not all stem cells are created equal. Many providers are unknowingly buying non-compliant products expanded in labs (which makes them a drug in the FDA's eyes) or processed in facilities that are only registered as "blood banks," not tissue processors.
Chuck’s Advice: Ask your supplier two questions.
Can I see your FDA Tissue Establishment Registration? (This is public info).
Can I tour your lab? If a supplier claims their lab process is "proprietary" and refuses a tour, that is a massive red flag. Transparency is your only safety net.
Stop guessing with your marketing. At Tobe Agency, we help healthcare and wellness entrepreneurs build the foundational systems they need to scale with confidence.
From compliant website copy to Local SEO that attracts high-value patients, we ensure you waste less and grow smarter.
Andrew Hong: Welcome to Grow Smarter, brought to you by Tobe Marketing & Media. As a founder, you know the pressure of making every marketing dollar count. My mission at Tobe Agency is to help healthcare and wellness entrepreneurs have more confidence, waste less, and grow smarter in their marketing media investments.
So today we're gonna talk about regenerative medicine, specifically stem cells, which is a hot topic in the healthcare, functional medicine, and wellness fields. Just a few things to note before we get the episode started today.
Number one, the market is booming. The global regenerative medicine market is projected to reach an estimated value of 169 billion US dollars by 2034. North America holds the largest market share and this demonstrates that regenerative medicine is a rapidly growing field that you might want to be paying attention to if you're a practitioner.
Patient demand is high. Patients are actively seeking these treatments to alleviate pain, avoid or delay surgery or as an alternative to conventional medicine. And this is the key to today's episode: the problem of misinformation. There's a widespread issue with exaggerated claims, quote-unquote "hype," and unproven therapies sold directly to customers.
This is where a partnership with our guest and a company like Hyagen Medical and an agency like Tobe becomes essential for compliant and ethical marketing. So we're joined today by an extraordinary entrepreneur and expert, Chuck Meeker.
As a co-founder of Hyagen Medical, Chuck is uniquely qualified to speak on this topic. He's not only a seasoned attorney, but he also holds a PhD in molecular biology and biochemistry from the University of Utah School of Medicine. His company, Hyagen Medical, works to help providers understand and talk about regenerative medicine in a meaningful and compliant way.
Chuck has dedicated his career to demystifying the intersection of science, technology, and medicine with laws and regulations, particularly in the biotech community. He believes that conversational regenerative medicine should be grounded in science and compliance, not hype, with the goal being to activate the body's natural healing abilities. We're honored to have him on the show today to provide a definitive blueprint for how to compliantly and effectively market regenerative medicine.
So welcome to the show, Chuck. Great to have you here today.
Chuck Meeker: Andrew, fantastic to be here. Thanks so much. What a kind introduction.
Andrew Hong: Yeah, no, no problem. So we always find it interesting in the work that I'm in, because I work with a lot of wellness practices, functional medicine practices, and we met at a very, I think a fortuitous time for me actually, because as I've been working with more of these functional medicine clinics over the last year or two, I have certainly seen this interest in providers wanting to provide stem cell therapy.
And I'll be honest, like I had no idea how to advise them on how to market it in a compliant way. And in fact, what we typically do is we don't touch it in terms of marketing, right? And so they're generally selling the treatments to their existing patients. But if they want to market it to new patients, there's a very tricky way... there's a lot of compliance rules that you could potentially fall into. In addition to that, with your existing patients, making claims can also get you into a lot of trouble.
So when we met, we met through an information session or a training that you were giving to a provider. And when I got your materials, I was just like, wow, this is literally the playbook to figuring out how to market this stuff in a really growing field.
So tell me a little bit about Hyagen Medical, kind of the genesis of it. You're a co-founder. Tell me about your other partner that's involved in it and sort of what you guys do.
Chuck Meeker: My other partner, my other partner is the most important partner in my life. So Hyagen Medical is actually my wife's company. She has a passion for regenerative medicine, functional wellness. And when she and I saw this industry being resurrected, particularly here in the state of Utah, she wanted to be part of this.
She said, "I feel like we have something to offer to clinical providers who are spending day in and day out focusing on getting their patients well." But we didn't see a lot of efforts to support the practitioners and what they do. So we saw practitioners supporting patients, but nobody's supporting practitioners. And so she said, "We need to do this."
I said, "There's no, I don't have time for this. I've got a full-time law practice and clients that are counting on me." She said, "I will start the company. I just need your support." And it was... I mean, it was an interesting proposition, right? She had supported me through my PhD program and supported me through law school as we had raised our kids. And here she was saying, "I want you to support me in starting this business." And I was just thrilled to do it.
So that's the genesis of Hyagen Medical. We focus entirely on providers, on clinical practitioners who want help doing things the right way so that we can move the needle for their patients.
Andrew Hong: Yeah. So for this episode, I kind of wanted to take more of an elementary education to a provider who, you know, may have heard about stem cells on a podcast out there, right? Or maybe a patient came in asking about it, right? But let's just kind of start with a sort of baseline definition and this idea of autologous and allogeneic stem cell therapies. So for our audience, can you really break down the differences in these two? And as a provider, why is it important to understand the differences in these stem cell therapies?
Chuck Meeker: Yeah, very good question. Great place to start. So you may or may not have heard the terms autologous and allogeneic stem cell therapy, but there's important distinctions.
Autologous stem cell therapy is referring to the industry of deriving or extracting stem cells from a patient's own body. As grown adults, we have stem cell deposits, archives of our stem cells in our bone marrow and in our fat tissue and in other tissues in the body. And you can literally aspirate or harvest that tissue and then derive the stem cells out of it to be administered back into the same patient therapeutically.
So this autologous stem cell industry rose on two, we'll call them facts for now. This industry rose on two pieces of information. Number one, the idea that your body's own stem cells are completely compatible with your body. So if you administer them to you, you don't have to worry about cellular rejection. We'll talk about the relevance of that as we go on with today's informational session. But that was one of the pieces of information.
The other critical piece of information is that providers felt like other forms of stem cells were not legal. And so the only thing they could do legally was to take the patient's own stem cells and give them back to the patient. Well, as you dig into federal and state regulatory compliance, what you find is there are legal pathways for using birth tissue derived stem cells, other sources of stem cells, if you follow the guidance that's been given by the regulatory bodies.
And going back to the first point, we find that the young stem cells from the birth tissue have a higher therapeutic capacity than the aged stem cells that are found in the patient's own body. So as far as superiority of technology is concerned, the evidence is pointing towards placental umbilical cord birth tissue derived stem cells for how superior they are.
Andrew Hong: Yeah. And this is potentially where some of the controversy sort of comes in with where those are sourced, right? And we'll get into that in a second, but Hyagen Medical specifically focuses on allogeneic products, right? Derived from birth tissue. Why would you say—and again, like you just mentioned, it's about the age—are there other reasons why that specific source of stem cells is superior? And what are the main advantages really for the provider and for the patient?
Chuck Meeker: Sure. So I would say first and foremost, it's less invasive to the patient. We don't need to go in and drill into the iliac crest or the hip bone. We don't need to aspirate out fat tissue. So from a patient experience, it's better to receive a therapy rather than to have a therapy taken from you and then have to receive it.
The therapeutic capacity of stem cells from your own body put back in... you've got to look at two different categories: the biological function of stem cells in the body as they exist naturally, and then the therapeutic function of stem cells when they're administered to a site other than where they're deposited. And I think there's a lot of confusion out there, a lot of "hype," as you say, about what stem cells will do that doesn't match up with what the literature and the data are showing stem cells actually contribute to therapeutically.
Andrew Hong: Well, let's double click on that. So let's draw this distinction between what are stem cells and what do they actually do? There's a surface level kind of explanation, and there's something that's much deeper here. And I think it ties back into the regulatory framework and compliance framework.
Chuck Meeker: So actually the surface level explanation is what causes most of the confusion in the industry. I'll bet that everybody listening to this episode has heard someone say stem cells are amazing because they have the capacity to grow into other cell types, differentiate into other cell and tissue types so that you can use a stem cell to regrow tissue in an area of the body. If you have damaged muscle, stem cells can grow into muscle and so on and so forth.
It's not incorrect. It's just largely irrelevant to the field of therapeutic stem cell administration. And why I say that is because the notion of stem cell differentiation into different tissue types really has a foundation in embryonic growth and development where a fertilized egg develops into a blastocyst that has a mass of embryonic stem cells and those embryonic stem cells hold the source or the stem for all the different cell types and tissue types that are needed to grow a new human being.
But here in the U.S., we're not harvesting embryonic stem cells from aborted fetuses. There are bioethical and safety issues associated with doing that. What we're talking about is after the baby is born, the birth tissues, the placenta and the umbilical cord, they contain vibrant bioactive molecular cells that have been termed stem cells. But they're not the stem cells produced by the growing fetus... they're the stem cells produced in the placenta, the command center for controlling the growth and development of a new human being.
And those placental stem cells are characterized biochemically the same way that other stem cells in the body are characterized, by their cell surface markers and by their growth factor and cytokine contents. So the only way you can classify these are as stem cells because of how they look biochemically, but their function biologically is much different... is incredibly different from the differentiating stem cells that we find in an embryo.
Rather than differentiating into different tissue types, placental stem cells—for example, the ones found in the umbilical cord blood that circulate through a growing fetus, a baby in utero—those stem cells are not little seeds that get planted in muscle and liver and bone and grow into new tissue. That's not how they function biologically. In fact, they're not even little construction workers that come in and repair damaged or injured areas. That's not what they do biologically.
Biologically, what they do is they carry a large portfolio of biological human growth factors and cytokines that provide a signaling function in the growing baby's body. Specifically, these biomolecules will bind to cell surface receptors in the growing baby's body and activate molecular pathways associated with regenerative healing and growth and repair.
It makes sense, right? Fetal growth and development is kind of a violent process. In the period of nine months, you're growing a human being. And that involves tearing cells apart and it creates inflammation and cellular debris. And there's not enough vasculature blood vessels to feed the system. So it kind of just turns off and you would get a spontaneous termination of pregnancy... but for the fact that the placenta is constantly sending these signaling molecule-filled stem cells into the baby's system to turn those molecular pathways back on.
So therapeutically, with the allogeneic stem cells, we harvest and purify these umbilical cord blood stem cells, for example, and we harness that power and use it therapeutically for the same purpose that they were being used biologically: to deliver those valuable natural biological human growth factors and cytokines in their entire portfolio. And wouldn't you know it, the body responds the same way therapeutically that it did biologically, by turning on molecular pathways associated with regenerative growth, healing and repair.
Andrew Hong: Yeah. I mean, that's such a nuanced sort of discussion. And I think what this is getting to is there's this key distinction between regenerative medicine—which is a term that I think is blanket used pretty often right now—and tissue engineering, right? Which there's a very, very distinct definition to both of those things. So, you know, obviously you're focused on regenerative medicine, right? And we're not... we're not growing tissue here. We're not growing things in a Petri dish, right? We're not doing any of that kind of stuff.
Chuck Meeker: And that is a thriving industry. Sure. There's a recent study out of the UK where they took stem cells and they... let's say they programmed them, right? They put different chemical compounds on them and they forced the stem cells down a differentiation pathway... forced them down that they weren't originally going to go down. But in a lab, they started sending these stem cells down the pancreatic islet cell differentiation pathway. And they went down so far that these cells began to produce human insulin. And then they transplanted those cells into the pancreas of a type one diabetic... That's the tissue engineering space. That's like stem cell transplantation.
We're not doing that. The stem cells that we use therapeutically, they don't stay around in the body. They don't get incorporated into your tissue and start growing someone else's cells in your body. They're delivery trucks, right? They're cargo trucks and they come and they drop off their natural growth factors and cytokines, and then their work is done. They just leave. The body takes care of that. The body identifies them as a cell that's not incorporated into tissue and it just gets rid of it. But not before their purpose has been accomplished, and that is to deliver the natural biological human growth factors and cytokines that bind cellular receptors and turn on pathways in the body. That's regenerative medicine.
Andrew Hong: So specific to Hyagen and how you source the stem cells, right? Can you tell us a little bit about sort of the supply chain, if you would, and how you get access to them and sort of your process for getting stem cells?
Chuck Meeker: Sure. Our philosophy is that a stem cell is only as good as the birth tissue from which it's derived and that the birth tissue is only as good as the mother in which it is grown. So we want to start with an ultra healthy population and then screen that population for healthy donor mothers. We've chosen to start in the state of Utah, which is known for individuals with an incredibly healthy lifestyle. No drinking, no smoking, no drug use, no tattoos, no communicable diseases, no multiple sexual partners. You get where I'm going with this, right?
So we start with a general population that has an incredibly high level of health. And then we screen potential donor mothers, volunteer donor mothers who have consented to donating their birth tissue. And the way this happens typically is in an OBGYN office. A soon-to-be mother will read a piece of literature and say, "I'd really be interested in donating my umbilical cord blood for research and therapeutic uses."
And then they're put in touch with a birth tissue recovery company that is registered with the FDA and contracted with the local hospitals to be there at the time of labor and delivery. And once the baby and mother are fully taken care of and the doctor says you're good to go, then the birth tissue can be recovered.
Okay, so the screening process... as you could imagine, with any blood or tissue derived product, there's a list of questionnaires for the patient. There's also family history questions, and then there's blood tests and tissue tests that are done. So we test the mother's blood before and after labor and delivery to make sure that there's no active infections or communicable diseases.
There's no compensation given to mothers for donating tissue. That's not legal in the United States. It's a lot like an organ donor card on your driver's license; out of the goodness of your heart you want to donate.
So once those tests come back, it's time for labor and delivery. We choose to use live, healthy, cesarean birth tissue. It's not because we encourage C-section. Cesarean allows three things that are important to Hyagen. Number one, a completely sterile tissue collection environment. If we can control for sterility, we will, and we always do. So C-section is important for that.
Number two is there's a lot less strain and stress put on the birth tissue in C-section recovery than in normal vaginal delivery. If we can lower the stress and strain put on the birth tissue, we can enhance the viability and the quality of cells that are in there, right?
And then number three, which is the most important to us... if we know when the C-section is scheduled, we can have our processing lab prepared and sterilized to receive and process the birth tissue on the same day as labor and delivery. This is pretty unusual in the industry. Usually you'll have a birth tissue recovery hospital out of state from where the processing lab is and they'll ship it overnight. Sometimes they'll freeze the birth tissue, but regardless, the time that it takes to get the birth tissue into the lab and processed, the freezing and thawing of the birth tissue puts stress and damage on it. It degrades the quality of it and the efficacy of it.
And then of course, once we're done processing the birth tissue in an FDA registered tissue processing lab... let's circle back to that in just a minute, by the way. Once that's done, then the products are sent out for independent third party testing because we want no bias in determining whether this product is free of contaminants, communicable diseases, infectious materials, anything like that. Only once we get back a clean certificate of analysis from an independent lab... will we move the product from cryo quarantine into cryo distribution.
Andrew Hong: Okay. So then, if a provider orders it, it's been manufactured and you can ship it out.
Chuck Meeker: Yeah. So back to the registration. There are many ways for a laboratory to register with the FDA. For example, a lab could register as a blood bank and they have an FDA registration and they can receive and they can store umbilical cord blood as a blood bank. And they may go out and tell providers, "We work with an FDA registered lab," but that registration is irrelevant to the production of a product. They don't have an FDA registration for processing and labeling and storing and distributing birth tissue derived products, human biological products.
So it's important what registration you have because the FDA audits and inspects labs differently depending on what level of registration they're seeking. So if you're a blood bank, the level of inspection is very low. They come in and they say, "Do you know how to store blood properly so that it doesn't get contaminated?" Yes. The level of inspection at a tissue processing lab, the audits that are done are more frequent and much higher. So you're given a level of assurance that this is not only a compliant lab, but that it's safe and it's using good manufacturing practices.
Andrew Hong: You know, there's an interesting parallel that just kind of came to my mind. Peptides have been a very interesting field over the last few years, right? There are a lot of peptide providers out there and there's a lot of them that maybe are not up to snuff in terms of the quality of the manufacturing. And so is that sort of a similar situation that you sort of see here with stem cell therapy... not all stem cells are created equal maybe is what I'm trying to get to.
Chuck Meeker: Very, very true. Yeah, I like that. Not all stem cells are created equally. Transparency is really key. If your providers, Andrew, are approached by a stem cell provider and you ask two basic questions, you'll get to the bottom of what you're looking for.
Number one: Can you show me your lab's FDA registration? Show it to me. They'll either tell you "Our lab is proprietary and they're not disclosed to the public because we don't want people circumventing us and going straight to the lab." That's a joke. Nobody cares about you knowing the lab; the lab and the distributor can work together to make sure there's no circumvention. What they're trying to do is keep you from knowing that their lab doesn't have a registration certificate. So you can ask them, "Can you at least tell me the name of your lab?" And I will look it up online myself. There's a portal online at the FDA.
Andrew Hong: Just like you would register on state business registration. It's got to be public information.
Chuck Meeker: That's right. If they won't tell you the name of their lab, it's a huge red flag.
Number two, which is my favorite is: Ask them if you're allowed to tour and inspect the lab for yourself. And most of them will say, "No, what happens in the lab is totally proprietary and confidential. We can't expose our proprietary information and processes to the public." That again, is a joke. 99% of what happens in the lab is industry standard. There's very few things... minor little tweaks about the rate of temperature change and the specific reagents that are being used, all of which can be kept hidden and confidential and you could still tour the lab.
So at Hyagen Medical, those two things are always offered. You want to see our lab registration certificate? Sure. Here it is online. It's active and registered right now. Number two, you want to tour our lab? Absolutely. Come to Lehi, Utah. I'll take you there myself. You'll sit and meet with the lab director, ask any questions that you want. You can see the facility and where we process birth tissue. There's nothing to hide. And when there's nothing to hide is when you know you're getting something that's on the up and up.
Andrew Hong: 100%. We kind of touched on this topic, but I actually don't think we brought a true definition to it. This idea of homologous use. What does it mean? And why is it actually one of the more important concepts that a practice owner might want to understand when they're thinking about offering these therapies?
Chuck Meeker: Yeah, so the term homologous use comes from the FDA guidelines for authorizing compliant human cellular and tissue based products (HCTPs) separate from the pharmaceutical drug pathway where you get an FDA approval. There is a 361 pathway for having human cellular and biological tissue based products... authorized, compliant with the FDA. So that they can be introduced into interstate commerce without being in violation of federal law.
So the term homologous use refers to the requirement that these 361 compliant HCTPs are intended for use therapeutically the same way that they were used biologically.
So now how does that apply to umbilical cord blood derived stem cells? You need to determine what is the biological function or use of stem cells and be able to market and label and intend to use those homologously in their therapeutic application.
So this comes full circle back to what we were saying at the beginning: biologically these cells are carrier vehicles for the natural biological human growth factors and cytokines. That's what they do.
Andrew Hong: Whether it's to a fetus growing, right. Or to a grown adult. It's still doing... it's just carrying things. That's all it's doing. It's just carrying the exosomes and cytokines, right.
Chuck Meeker: So at the beginning, we talked about this being good science, good understanding for what's really going on. But now we're talking about regulatory compliance. And it turns out that those two things are the same. Good science is what is compliant.
So as you, as a practitioner, talk to your patient about therapeutic stem cells, when you say things like "stem cells grow into different tissue types and we can use it to repair tissues," it's biologically inaccurate. It's also dangerously non-compliant with federal regulations. So we need to make sure we lock that up. When you talk about stem cells healing a damaged area of the body or reducing inflammation or anything like that, you're not just giving bad science, you're giving non-compliant medical claims about what cells do.
Andrew Hong: It's the stuff that's inside the trucks, right? It's the Amazon packages inside the Amazon thing that actually do the healing. But when we talk about stem cells, an Amazon truck is an Amazon truck is an Amazon truck, whether it's a fetus receiving it or a grown adult getting it through an injection.
Chuck Meeker: I tell you what... truth be told, it's not even what's inside the stem cell that matters. So the Amazon truck is great. The package carried in the Amazon truck is great. Inside the package, there is a recipe or an instruction to follow, but the recipe doesn't do anything on its own. It takes a chef, right? So the body is the chef, follows the recipe that was delivered in a package that was driven by the mail truck.
So who's the hero in the story? The hero is the human. Our body is evolutionarily programmed to heal and regenerate itself. In fact, those growth factors and cytokines that are found in stem cells, they're already in our own bodies. That's what we use, especially when we're young. When you sprain an ankle when you're young and it gets swollen and three days later, the swelling is down and you're back on the playground, your body is full of these regenerative molecules and the pathways for regenerative healing are so active that you heal and recover very quickly.
As we age, the content and concentration of those biomolecules decreases, the activity of your cellular molecular mechanisms gets turned down, and we call it aging. But it's just molecular deactivation. And if we can reactivate the molecular pathways, we get that same regenerative healing capacity.
So what do we do? We deliver more of the bioactive molecules that we know are involved biologically in those pathways. And we use stem cells as the delivery vehicle for doing that. That is biologically accurate and it's incredibly compliant.
If you'll stop when someone asks, "What does a stem cell do?" Simply say: "Stem cells are nature's carriers, they're couriers. Stem cells carry and deliver natural biological human growth factors and cytokines. That's what they do. Full stop."
Now, those biomolecules, those growth factors and cytokines, they have a biological counterpart in your own body. And our body uses its growth factors and cytokines as molecular signaling molecules to turn on pathways associated with regenerative repair. So why are we delivering the stem cells to you? Because they contain the same molecules that our body needs.
Andrew Hong: That's compliant language. It's homologous use, right? Correct.
Chuck Meeker: So homologous use is one of the federal regulatory requirements. There's another huge one and that is minimal manipulation. One of the other federal guidelines is that the product be minimally manipulated from its biological source to its therapeutic product form. So for example, if you're altering the structure or the form, if you're expanding or growing these stem cells out so that they're not natural stem cells, they're semi-synthetic laboratory grown stem cells... The FDA could come in and say, well, that's not minimal.
So for Hyagen Medical, we obviate this issue. We say these are the first generation natural umbilical cord blood derived stem cells. These are the actual cells that have not been manipulated. The only thing that we've done is remove the blood components.
Other companies, other labs, will take the stem cells and then they'll grow them in culture so that instead of 10 million stem cells, they have 20 or 50 or a hundred million stem cells. Sometimes you'll even see people going to Mexico to get a hundred million stem cells because cellular expansion is legal in Mexico and not in the U.S. Here in the U.S., if you have a provider telling you they're gonna give you lab grown or lab expanded stem cells, it's a huge red flag, you're not administering a compliant product.
Andrew Hong: So, you know, if you're a provider out there, maybe thinking about offering stem cell therapy, all these distinctions that Chuck is sort of drawing here... it can have a lot of implications for sort of where you lie in terms of compliance. And I think what you thought about is how do I build a supply chain that eliminates all of this and the provider never has to worry about this because from day one and from the very source... homologous use, right... where all of that, like we are compliant with these things.
Chuck Meeker: You bring up a lot of good points in that statement right there. So the concept of providers not having to worry because the product is sourced properly is found in the federal regulatory guidelines. The 361 compliant HCTP products, the requirements for those ends at the distribution.
So this all matters from an FDA compliant standpoint: how the tissue is sourced, transported, processed, labeled, stored and distributed. There is a specific line in the regulatory guidelines that says: if you are only receiving a 361 product for the purpose of administration within your facility, these requirements do not apply to you.
In other words, clinical practitioners do not have any additional regulatory burden placed on them from the federal government as long as they're receiving compliant 361 HCTPs.
So now it's critical for you as a provider to know that you're receiving the product because then the only thing you have to worry about is your state professional licensing scope of practice requirements.
Now, what you have to worry about is not screwing it up once you get it. And how a provider screws it up is by marketing their product in a non-compliant way. Everything we've done to build a compliance supply chain goes out the window the first time a provider says, "We're going to administer stem cell therapy to heal your injured shoulder and help you avoid surgery." It all goes out the window. Every time you say these stem cells will reduce inflammation systemically in your body. Your words matter.
Andrew Hong: Can you give me just a couple examples of like, "Hey, a lot of people say this, say it this way instead"?
Chuck Meeker: Yeah. So when you're going out into the world electronically, your main goal is to get attention. And a lot of times you can do that just by appealing to celebrity value. So saying something like, "Kobe Bryant had to travel to Germany to get stem cell therapy. You can get stem cell therapy in the US now. Come ask us whether stem cell therapy is right for you." It doesn't make any claim about what stem cells do. There's no problem there.
And I guess we should stop for just a second, Andrew, and correct a misconception. There is no federal guideline or requirement or restriction on using the term stem cell or exosome or regenerative medicine in your marketing material. Everyone got so confused about improper stem cell marketing that they made the word stem cell the boogeyman.
Andrew Hong: Yep, exactly. That was me for sure.
Chuck Meeker: The problem is not saying stem cells. The problem is tying stem cells to an outcome or tying stem cells to a disease that's being treated or saying that the stem cells affect the structure or function of the body. That's not what they do. It's biologically inaccurate and it's non-compliant regulatorily.
So let's stick to what's true. "Stem cells are nature's carriers. They deliver natural biological human growth factors and cytokines." We know scientifically from the published literature that those same growth factors and cytokines are what our body uses naturally to turn on regenerative growth pathways... We're not saying what the stem cells will do. We're not even saying what the growth factors and cytokines will do. We're certainly not saying that we're going to affect the structure or function of the body or treat a disease or provide an outcome. We're using science to help the patient understand what stem cells deliver... so that their body becomes the hero in the story.
Andrew Hong: Chuck, thank you so much for spending the time with us today. If you're interested in working with Hyagen Medical and Chuck and his team, go to their website at HyagenMedical.com. Chuck, thanks so much for coming on today.
Chuck Meeker: Great to be here. Look forward to chatting again soon.