Podcast: Play in new window | Download
Subscribe: Apple Podcasts | Amazon Music | RSS | More
Dr. Deb Muth 00:04
What if the future of healing isn’t about replacing cells, but about teaching your body how to heal itself again? We keep hearing the words stem cells and exoomes thrown around like they’re interchangeable, but they’re not. One is regulated, controversial, and often misunderstood. The other is rapidly emerging as one of the most exciting communication systems in human biology.
Dr. Deb Muth 00:33
And here’s the real question no one’s asking. Are we actually regenerating tissue or are we just stimulating the body to remember how it used to heal? Tired of being told your labs are normal, but you still feel terrible? At Serenity Healthcare Center, we don’t chase symptoms. We find the root cause. hormones, gut health, autoimmune conditions, chronic fatigue, brain fog.
Dr. Deb Muth 01:02
We use cuttingedge functional and regenerative medicine to get you real answers and a real path forward. This isn’t your average doctor’s office. This is medicine the way it was meant to be practiced. You deserve to feel like yourself again. Visit serenityhealthcarecenter.com to book your appointment today. Let us help you heal from the inside out.
Dr. Deb Muth 01:28
Welcome back to Let’s Talk Wellness Now. I’m Dr. Deb, your host. And if you’ve been following regenerative medicine, you’ve probably noticed the confusion. Patients are asking me every week, are exoomes stem cells? Are stem cells legal in the United States? I heard the FDA is shutting down all these clinics. Can I even get this therapy? Do I have to leave the country for treatment? Today, we’re cutting through the noise. This episode is not hype.
Dr. Deb Muth 01:54
It’s not sales. It’s education so you can understand the science, the regulatory reality, and the clinical difference between stem cell therapy and exoome therapy. And here’s what I want you to know right up front. Yes, these therapies are being used in the United States every single day. Yes, they’re being offered by highly trained physicians in integrative and regenerative medicine clinics across the country.
Dr. Deb Muth 02:22
Some are being used in FDA registered clinical trials. Some are being used in observational studies and some are being used in clinical practice under physician discretion. The landscape is nuanced and you deserve to understand it. So, grab your cup of coffee or tea and settle in for a deep dive into the most understood therapies in regenerative medicine.
Dr. Deb Muth 02:43
what they actually are, how they work, the regulatory landscape, and how they might support your body’s natural healing capacity. Let’s talk wellness now. So, let me start by asking you something. When you hear the word stem cell, what do you picture? Most people imagine damaged tissues magically regenerating or a torn meniscus growing back, cartilage reforming it into an arthritic joint or damaged brain tissue being replaced with healthy new beautiful cells. It’s a beautiful vision.
Dr. Deb Muth 03:15
And while it’s not quite that simple, the reality is actually more sophisticated and honestly more beautiful. Stem cells are powerful and they absolutely work, but the way they work and the mechanism by which they support healing is far more elegant and more so than most people really understand. And if you’re going to invest in regenerative therapy, you deserve to understand what you’re actually receiving.
Dr. Deb Muth 03:44
So, let’s start at the beginning. What are stem cells? At their core, stem cells are undifferentiated cells. That means they haven’t yet decided what they want to be when they grow up. Unlike a heart cell or a skin cell or a bone cell which have already committed to a specific function, stem cells exist in this beautiful state of potential.
Dr. Deb Muth 04:05
They have two remarkable abilities. First, they can self-renew. They can make copies of themselves, maintaining a reserve of these powerful cells throughout your lifetime. Second, they can differentiate under the right conditions. They can transform into specialized cell types. Bone cells, cartilage cells, nerve cells, muscle cells, even blood cells.
Dr. Deb Muth 04:27
This is why they’ve captured the imagination of the medical world. The potential is extraordinary. Now, there are several types of stem cells and understanding the differences matters tremendously for both understanding how they work and understanding how they’re regulated. Adult mezzenymal stem cells. We call these MSC’s are the most commonly used regenerative medicine.
Dr. Deb Muth 04:54
These come from bone marrow, atapost tissue, that’s fat, and other adult sources. They’re what we can call multi-potent, meaning they can become several types of cells, but not every type. A bone marrow stem cell isn’t going to become a brain cell, for instance. It has potential but it’s directed potential.
Dr. Deb Muth 05:19
Then we have perinatal stem cells. These come from umbilical cord blood cord tissue or something called Wharton’s jelly which is the gelatinous substance inside the umbilical cord. These cells are younger, more potent, and research by Weiss and colleagues published in stem cells back in 2006 showed that Wharton’s jelly derived MSC’s have superior proliferation and differentiation potential compared to bone marrow derived cells.
Dr. Deb Muth 05:48
They’re like comparing a 20-year-old athlete to a 50-year-old athlete. Both can perform, but one has more reserve capacity, more vigor, and more regenerative potential. And this isn’t this is very important because the perinatal sources umbilical cord tissue Wharton’s jelly amniotic tissue these are what many regenerative medicine clinics in the United States are using today and they’re using them because these tissues are incredibly rich in not just stem cells but growth factors cytoines and exoomes.
Dr. Deb Muth 06:21
Then there are embryionic stem cells. These are pur potent and they become any cell type in the body, but they’re highly regulated, ethically controversial, and honestly, they’re not being used in clinical practice in the United States outside of the very specific FDA approved research trials.
Dr. Deb Muth 06:41
So, when clinics talk about stem cell therapy, they’re almost never talking about embryionic stem cells. Now, here’s where it gets interesting and this is the part that changes everything about how we understand regenerative medicine. When you receive stem cell therapy, let’s say someone injects umbilical cord derived messenymal stem cells into your arthritic knee, those cells do not typically engraft or become new tissue in any permanent way.
Dr. Deb Muth 07:12
They don’t set up shop in your joint and start cracking out new cartilage cells for the rest of your life. So what are they actually doing then? Well, in 2011, researchers Arnold Arnold Kaplan and Dennis Korea published a landmark paper in stem cells translational medicine that fundamentally changed how we understand MSC therapy.
Dr. Deb Muth 07:35
They proposed that we should stop calling memal stem cells and start calling them medicinal signaling cells. Why? Well, because their primary therapeutic benefit doesn’t come from what they become. It comes from what they secrete. Think of stem cells as incredibly sophisticated biological pharmacies. When you inject them into damaged tissue, that arthritic knee, that inflamed autoimmune condition, that injured brain, that don’t just sit there passively, they sense the environment.
Dr. Deb Muth 08:07
They detect inflammation. They recognize the tissue damage and they understand that the immune dysregulation is present and they see that and respond. They start pumping out hundreds of bioactive molecules, growth factors that tell your cells to repair and rebuild, cytoines that modulate inflammation, chemocines that recruit your body’s own healing cells to the area.
Dr. Deb Muth 08:32
And these tiny membranes bound packages called extracellular vesicles, including exosomes, which we’re going to talk about extensively today as well. These secreted factors are giving instructions to your native cells. They’re saying, “Let’s reduce inflammation. Let’s modulate your immune response. Let’s promote angioenesis.
Dr. Deb Muth 08:53
” That’s the formation of new blood vessels, bringing nutrients and oxygen. Let’s stimulate your own resident stem cells to wake up and get to work. Reduce cell death in damaged tissue and restore normal cellular function. This is called paracrine signaling. It’s the cellto cell communication. And this is where the real therapeutic power lives.
Dr. Deb Muth 09:14
The stem cells themselves, many of them die within days to weeks, but the cascade of healing they trigger, the signals they send, the programs they activate in your own cells, those effects can last for months or even years. Now, this understanding is crucial because it explains why both stem cell therapy and exoo therapy can be effective.
Dr. Deb Muth 09:38
The stem cells are powerful not because they become new tissue but because of the signals they send and exoomes are those signals isolated and concentrated. The biggest misconception in regenerative medicine is that stem cells replace tissue and in reality they coach healing more than they become healing. They’re biological educators teaching your body to remember how it used to heal before chronic inflammation, toxicity, and disease turned off all those programs.
Dr. Deb Muth 10:12
So if stem cells don’t exactly end graft and become the new tissue, if their power is in their signaling and then next logical question is why do we need the cells at all? Well, if we could isolate the messengers themselves, what if we could deliver just the communication systems without any of the complexity of the living cells? Well, that’s exactly what exosomes are.
Dr. Deb Muth 10:38
And they represent the cutting edge of regenerative medicine. So, let me paint you a picture of how cells actually communicate. Because for most medical history, we had it wrong. For decades, textbooks taught us that cells talk to each other in two basic ways. through direct contact like shaking hands or releasing signaling molecules that floated through the extracellular space like messages in bottles, simple chemical messages.
Dr. Deb Muth 11:09
But in the 1980s and 90s, researchers started discovering something far more sophisticated. cells were releasing these tiny membrane bound packages like a biological FedEx envelope kind of you know it was filled with complex specific cargo and these packages could travel through the blood cross the barriers that normally keep things out like bloodb brain barrier and deliver their contents to distant cells with remarkable precision.
Dr. Deb Muth 11:38
These are called extracellular vesicles. And exoomes are one of the most therapeutic important types. So what exactly are exosomes? Well, they’re nanosized vesicles, typically 30 to 150 nanome in diameter. To put that into perspective, a human hair is about 100,000 nanometers wide. These are incredible and most impossibly tiny.
Dr. Deb Muth 12:09
They’re released by virtually all cells in the body, but the most therapeutically interesting exoomes come from mezenymal stem cells. And those medicinal signaling cells we just discussed. And according to a landmark review of Raposo and Stervogal, they published in the journal of cell biology in 2013, exoomes are not cellular debris. They’re not waste products.
Dr. Deb Muth 12:35
They are precisely engineered communication vesicles or vehicles. Think of them as sophisticated delivery systems carefully packed, carefully labeled, and sent to specific destinations. very specific instructions. Inside each of these exoomes, you’ll find an incredibly sophisticated payload. They are microRNAs. These are small RNA molecules that can literally turn genes off or on in the recipient cells.
Dr. Deb Muth 13:06
They can tell a cell to start making more collagen, to reduce inflammatory proteins, to activate repair programs that have been shut down by chronic disease for a very long time. There are messenger RNAs, actual templates for protein production. And exoome can deliver these instructions for making healing proteins. There are proteins themselves, growth factors, cytoines, enzymes, all the molecular tools a cell needs to heal.
Dr. Deb Muth 13:34
And there are lipids, specialized fats that help the exoome membrane fuse with targeted cells, delivering the cargo inside. When an exoome reaches its target cell, it can either fuse the cell membrane and deliver its contents directly inside like a Trojan horse, or it can bind to surface receptors and trigger signaling cascades, setting off a chain reaction of healing responses.
Dr. Deb Muth 14:01
Either way, it’s delivering very specific targeted instruction. And here’s what makes this so powerful. Those instructions are tailored to what this recipient cell actually needs. So, let me give you some concrete examples of what the research actually shows because this is where it really gets exciting. When researchers inject MSC derived exoomes into hearts that had experienced eskeeia, reprofusion, injury, that’s damaged blood flow being cut off and then being restored.
Dr. Deb Muth 14:36
Kind of like what happens during a heart attack. Something remarkable happened. A study by Lei and colleagues published in stem cell research in 2010 showed that exoomes significantly reduced the size of the damaged area, reduced inflammatory cytoines that drive tissue destruction and promoted tissue repair signaling. The exoomes were telling the heart cells stop the inflammatory cascade, activate your survival programs and repair the damage.
Dr. Deb Muth 15:06
In cartilage research, tow and colleagues published work in biioaterials in 2017 showing that exosomes derived from MSC’s could promote cartilage regeneration in osteoarthritis models. And the exoomes carried specific microRNAs that told condondroytes cartilage cells to proliferate and make more extracellular matrix, the structural framework of healthy cartilage.
Dr. Deb Muth 15:30
for autoimmune conditions. Research by Blazic and colleagues in Frontiers in Immunology in 2014 demonstrated that MSC derived exoomes could shift immune cell behavior from pro pro-inflammatory to regulatory. They could take an overactive self-attacking immune system and restore balance and promote tolerance. And perhaps most exciting brain research, a study by Zinn and colleagues published in the journal of extracellular vesicles in 2013 showed that MSC derived exoomes could cross the bloodb brain barrier.
Dr. Deb Muth 16:07
That protective shield around your brain that normally keep things out and promote neurological recovery in stroke models. They reduced brain inflammation, promoted neuroplasticity, supported the formation of neural connections, and for mitochondrial dysfunction, which underlies so many chronic conditions, Morrison and colleagues published research and scientific reports in 2017 showing that MSC derived exoomes can actually deliver functional mitochondria or mitochondrial components to damaged cells. They’re not
Dr. Deb Muth 16:40
just sending instructions, they’re sending spare parts. They’re restoring the cellular powerhouses to produce energy. So why are exoomes fundamentally different from stem cells? Well, exoomes contain no living cells. They can’t replicate. They can’t end graph. And they have virtually no risk of immune rejection or tumor formation.
Dr. Deb Muth 17:03
Concerns that exist elevate rarely with cellular therapies. They’re essentially biological software updates for your cells. As Fineian Pitiger wrote in their seinal review in stem cells in 2017, MSC derived exoomes represent the active ingredient of stem cell therapy delivered in a cellfree format. That’s the key insight in the in the therapeutic benefit of stem cells and it comes from what they excrete.
Dr. Deb Muth 17:33
Then exoomes are the secretion isolated, concentrated, and standardized. From a practical clinical standpoint, exoomes offer several compelling advantages. First, consistency. Because exoomes can be isolated, characterized, and standardized, each dose can be remarkably consistent. With living stem cells, there’s variability based on donor age, health status, processing methods, and one batch may be robust, but another might be weaker.
Dr. Deb Muth 18:05
With exoomes, you can measure the content, measure the potency, and ensure the quality control. Second is storage. Exoomes can be liophalized. They can be freeze-dried and stored at room temperature or refrigerated for extended periods. Stem cells require cryopreserv preservation, careful freezing, careful thawing. They’re fragile.
Dr. Deb Muth 18:31
Exoomes are remarkably stable. And third, their safety profile. Without living cells, the risk of adverse imunological reactions is dramatically lower. You’re not introducing foreign cells that your immune system might recognize and attack. You’re introducing molecular messages. Fourth is scalability. You can harvest millions, even billions of exoomes from stem cell cultures without ever injecting the cells themselves.
Dr. Deb Muth 19:01
And you can produce large quantities, standardize them, and make them available to patients. Now, there is a caution here in doing this. The scalability can produce rogue cells, and we want to be cautious of that. So, here’s what I need you to understand. Exoomes don’t force healing. They remind the body how healing works.
Dr. Deb Muth 19:24
They’re not replacing damaged cells. They’re re-educating the cells you already have. They’re turning back time on the biological programs that got turned off by inflammation, toxicity, trauma, time, and chronic disease. Your body knows how to heal. It’s done its entire life. Every cut that closed, every bone that mended, every infection you fought off, your body orchestrated that healing.
Dr. Deb Muth 19:51
The problem is that chronic disease, chronic inflammation, toxic exposures, poor nutrition, stress, all of these things disrupt the communication networks that coordinate healing. And exoomes restore that communication. They’re like rebooting a computer that’s frozen. They reset the system and remind it how it’s supposed to function. All right.
Dr. Deb Muth 20:14
So, this would not be complete if we didn’t talk about regulation because this is where a lot of confusion exists. And I want you to be given a real picture. Not fear-mongering, not pretending. There aren’t regulatory considerations, but the actual practical reality of how regenerative medicine is practiced in the United States today.
Dr. Deb Muth 20:38
Here’s what you need to understand. The FDA regulates these therapies and they have specific frameworks, but there’s important nuances between regulatory text enforcement priorities and actual clinical practice. And there are also state level regulations that provide additional pathways. The FDA regulates human cells, tissues, and cellular and tissue based products.
Dr. Deb Muth 21:05
We call them HCT/PPS under two main pathways. Section 361 products are those that meet specific criteria. They’re minimally manipulated, intended for homologous use, meaning these tissues perform the same basic function in the recipient as it did in the donor. They’re not combined with non-tissue components and they’re either autotogus, meaning they come from your own tissue, or they have had minimal systemic effect.
Dr. Deb Muth 21:38
An example of a clear 361 procedure, your doctor harvests your own bone marrow, we call this PRP, performs minimally processing to or uh perform Yeah. performs minimal processing to concentrate the stem cells through a centriuge and injects it into your arthritic knee the same day. That’s autogus same day but minimally manipulated.
Dr. Deb Muth 22:04
This is unquestionably legal and is being done in regenerative medicine clinics across the country every single day. So there’s section 351 where products are those that don’t meet all the section 361 criteria. They’re classified as drugs or biologic products and they require FDA approval through clinical trials.
Dr. Deb Muth 22:27
Now here’s where this gets more nuanced. There are regenerative medicine clinics across the United States using stem cell and exoome therapies in different contexts. First FDA registered clinical trials. These are formal research studies with investigational new drug applications. Patients enroll in trials. They sign informed consents.
Dr. Deb Muth 22:48
They receive therapies as part of their structured research protocols. And this is completely legal and represents the gold standard for gathering evidence. Second is observational studies and registry programs. Many clinics are collecting systemic data on patient outcomes using these therapies even outside the FDA trials.
Dr. Deb Muth 23:12
They’re documenting results, tracking safety, and contributing to the growing body of clinical evidence. Third, there’s clinical practice under physician discretion. There are physicians using these therapies based on their own clinical judgment informed consent from patients and their interpretation of the regulatory framework particularly around minimal manipulation and homologous use.
Dr. Deb Muth 23:34
Now there are also state regulations that provide additional legal frameworks. So, for example, Florida has enacted the Right to Try Act and specific regenerative medicine legislation that allows physicians to offer certain stem cell therapies under the state oversight. Utah has passed similar legislation creating pathways for regenerative medicine products.
Dr. Deb Muth 23:57
And these state laws recognize that patients should have access to potentially beneficial therapies, particularly when used by trained physicians with appropriate informed consent. The regulatory question often centers around are these products minimally manipulated. Some products clearly are not. They’ve been cultured.
Dr. Deb Muth 24:20
They’ve been expanded in laboratories and those require FDA approval that they don’t have. The FDA has appropriately shut down clinics using those products. But there are other products that undergo processing that many physicians and manufacturers argue constitutes minimal manipulation. And these tissues are cleared, potentially fragmented or particulated to make them more suitable for injection, preserved using methods like cryopreservation or liophalization and packaged.
Dr. Deb Muth 24:54
But the cells are not cultured or expanded in the laboratory. The FDA has issued guidance suggesting that many of these processing steps constitute more than manipul minimal manipulation. But many physicians, particularly those who specialized in regenerative medicine for years, disagree with that interpretation and they believe that the processing qualifies as minimal manipulation and that the product should fall under section 361 when used for homologous purposes.
Dr. Deb Muth 25:24
Is there regulatory debate? Absolutely. The FDA and some clinicians have different interpretations of what constitutes minimal manipulation. But here’s the practical reality. There are hundreds of well-trained, bore certified physicians across the United States offering these therapies every single day.
Dr. Deb Muth 25:42
They’re doing so based on their understanding of the regulations, their clinical experience, their commitment to patient safety, and their belief that these therapies can help people who have exhausted conventional options. The FDA’s enforcement priorities have focused primarily on the most problematic cases. Clin clinics making blatant disease cure claims, products with documented safety issues, clear cases of cellular expansion and culture, or clinics operating with no medical oversight.
Dr. Deb Muth 26:15
Reputable regenerative medicine physicians are using products from companies that provide comprehensive documentation of their processing methods. third-party sterility testing, certificates of analysis showing bioactive content, and quality control measures that meet or exceed industry standards. Now, let me be very clear about something.
Dr. Deb Muth 26:36
Quality matters enormously. Not all stem cells and exoome products are created equal. Research by Burger and colleagues published in the Orthopedic Journal of Sports Medicine in 2021 analyzed 12 commercially available stem cell products and found that many contained zero viable cells, high levels of bacteria, endotoxins and inconsistent growth factor concentrations.
Dr. Deb Muth 27:01
This is why the company providing these biologic matters tremendously. You want products from manufacturers who provide transport documentation in sourcing and processing. Conduct third-party testing and sterility and potency. Offer certificates of analysis for each batch. Use standardized validated processing protocols.
Dr. Deb Muth 27:24
Have quality control measures that ensure consistency and don’t make outrageous cure claims or promise. The best regenerative medicine physician carefully vet their suppliers. They don’t use products from companies making unrealistic promises. They use products from manufacturers who are transparent, scientifically rigorous, and committed to quality.
Dr. Deb Muth 27:46
Now, you specifically ask about homologous use and collagen defects. So, let me address this directly for you. Under the FDA guidance, homologous use means the tissue performs the same basic function in the recipient as in the donor. So for connective tissue, tendons, ligaments, cartilage, fascia, all of that which are collagenrich structures using MSC’s or their derivatives could be considered homologous use.
Dr. Deb Muth 28:17
MSC’s in their native environment provide structural support to produce extracellular matrix including collagen. Using them to support healing in damaged collagen rich tissues like arthritic joints, torn tendons or degenerative ligaments is arguably the same basic function. So using exoomes derived from MSC’s to support collagen synthesis reduce inflammation and promote tissue healing in the same structures.
Dr. Deb Muth 28:46
Many practitioners argue this also qualifies as homologous use because you’re supporting the structure and function that MSC’s would naturally support. So here’s the bottom line on the regulatory reality. Regenerative medicine is available in the United States. It’s being offered by highly trained physicians in integrative and regenerative medicine clinics across the country.
Dr. Deb Muth 29:11
Some therapies are offered in FDA registered clinics and some are offered in observational studies. Some are offered in clinical practice under physician discretion, informed consent, and careful attention to safety. The regulatory landscape is evolving. There are ongoing discussions both federally and state levels about creating clearer pathways for these therapies.
Dr. Deb Muth 29:32
So, if you choose to go down this road, you want to work with physicians who understand the regulations, who use quality products from reputable manufacturers with rigorous testing and documentation, who are transparent about what they’re using and why, who discuss the current regulatory landscape honestly with you, and who prioritize your safety and truly informed consent above all else.
Dr. Deb Muth 29:55
This is not a lawless wild wild west. But it is also not as simple as everything is legal and unavailable. It’s a nuanced landscape that requires ethical knowledge. And these practitioners that have this knowledge have got to provide informed patients who understand both the potential benefits and the current regulatory context.
Dr. Deb Muth 30:17
So let’s have some fun here. Let’s talk about what really matters to you that are listening and that’s what conditions are being supported with these therapies. What does the research show and what are clinicians seeing in actual practice with patients? Because here’s what’s really important. We have both published research evidence and extensive clinical experience.
Dr. Deb Muth 30:38
And when the two align, that’s when we can feel confident and comfortable about using these approaches. So, let’s start where we have the most substantial evidence. joint health and muscularkeeletal conditions. For arthritis, we have good data. A systemic review by Tan and colleagues published in arthritis research and therapy in 2021 analyzed 20 randomized controlled trials in MSC therapy for knee osteoarthritis.
Dr. Deb Muth 31:05
They found significant improvements in pain and function particularly in mild to moderate disease. What’s really interesting is when researchers start analyzing whether it was the cells themselves or their secreted factors doing the work. They found that exoomeenriched preparations showed similar benefits to whole cell therapy.
Dr. Deb Muth 31:26
Now towen colleagues in the biioaterials paper from 2017 demonstrated that MSC derived exoomes could promote cartilage matrix synthesize and reduce inflammation markers. The exoomes carried microarnas that told cartilage cells to make more collagen and proteoglycans, the building blocks of healthy cartilage.
Dr. Deb Muth 31:49
In clinical practice, physicians are seeing patients with knee, hip, shoulder, and spinal arthritis, experiencing reduced pain, improved function, better motility, and in some cases, measurable improvements in their tissue. I want to share a story here with you because back in 2006, my husband was injured at work. Some of you might have heard me tell this story before.
Dr. Deb Muth 32:11
Um, he broke two discs in his back and underwent surgery very early on when we started using stem cells. They had put cages and plates in and they used MSC’s to put inside the cage to create a hardened bone so that he could have a fusion and hopefully not have any pain. At the time, what the physician didn’t realize or mistakenly did was he did not put any human bone mixed with these dead cadaavver bone MSC’s.
Dr. Deb Muth 32:42
And so the MSC’s never grew. They didn’t have anything to grow by. So the plates and the screws just kind of went back and forth for six months before he could see another physician that would look at him differently and understand what actually happened. That was very early on. Today we know so much more than we did before.
Dr. Deb Muth 33:01
Fast forward to 2014 when my husband was having problems and he couldn’t feel his legs, he couldn’t feel his feet. We decided to undergo uh exoo and stem cell therapy again and we saw a physician in Florida who harvested cells from his bone marrow and his blood and his fat and mixed that all together and then put that back into the back.
Dr. Deb Muth 33:27
and he had tremendous benefit from it. So, I tell this story because I want you to see the trajectory of how long this has been going on that we’ve been using this and we’re learning as we’re going and things are changing rapidly in this in this world. And so, what we know today and what I’m teaching you today may very well change in a month or six months or a year from now, but we have the foundation at least to understand what is helpful, what is not right now.
Dr. Deb Muth 33:54
But just be aware that if you’re embarking on exoome or stem cell therapy or MSC’s that you understand that this terrain is going to change. So back to my conversation about what other things can we treat? Well, we can treat tendon and ligament injuries, chronic tennis elbow, Achilles tendonopathy, rotator cuff tears, chronic planter fasciitis.
Dr. Deb Muth 34:17
These were researched by PA and colleagues in the American Journal of Sports Medicine in 2017 and it showed that bone marrow concentrate injections resulted in improved pain and function compared to steroid injections. Now this mechanism appears to be enhanced collagen remodeling and reduced chronic inflammation.
Dr. Deb Muth 34:39
These are structural collagenrich tissues using MSC’s or their derivatives for structural support which makes biological sense. It’s homologous use. It’s similar. So clinically we’re seeing athletes, active adults and people with chronic pain who failed physically um failed physical therapy, failed conservative treatments finding relief in this functional uh improvement in this functional world that we live in today.
Dr. Deb Muth 35:07
So, I want to be clear about what we’re doing here for joint and muscularkeeletal issues. We’re not growing completely new cartilage from scratch or severely destroyed joints. We’re not magically regenerating tissues that’s been gone for decades. That’s not possible here. What you’re doing when you’re using MSSE’s and exoomes is supporting the body’s natural ability to repair, reducing inflam inflammation and damage, and we’re driving progressive degeneration uh or we’re stopping the progressive degeneration. By reducing the
Dr. Deb Muth 35:41
inflammatory damage, we’re stimulating resonant stem cells that have been dormant. We’re improving blood flow and uh uh oxygen to the tissues like cartilage and tendons. and we’re organizing the body to start creating its own quality collagen as it heals. So, it’s a regenerative support, not a tissue replacement.
Dr. Deb Muth 36:07
But for many people, this support is lifechanging. So, let’s talk about autoimmune disorders now because this is one of the most exciting and unrecognized applications. autoimmune conditions like rheumatoid arthritis, lupus, MS, Crohn’s disease, ulcerative colitis, Hashimoto’s, they all involve the immune system and the immune system is deregulated.
Dr. Deb Muth 36:30
And so basically your immune system is seeing this tissue as foreign and it’s attacking it. These MSC’s and their exoomes have profound immune modulatory properties. They don’t suppress the immune system like steroids or imunosuppressive drugs. They modulate it helping to restore balance. So for rheumatoid arthritis, research by Weang and colleagues in stem cells translational medicine in 2016 showed that MSC derived exoomes could shift the balance of immune cells, reducing pro-inflammatory TH7 cells that drive joint disruption uh and increase
Dr. Deb Muth 37:08
regulatory TE-C cells that maintain immune tolerance. So for MS, a clinical trial by Kasus and colleagues published in archives of neurology back in 2010 evaluated autotogus MSC therapy and MS patients and they found evidence of reduced disease activity, improved neurological function and decreased inflammatory uh lesions on MRI scans.
Dr. Deb Muth 37:34
The proposed mechanism is MSC’s and their exoomes reduce inflammatory cytoine production promote regulatory imu immune populations support remination of damaged nerves that is rebuilding the protective coating around the nerve fibers and it reduces bloodb brain barrier permeability which prevents immune cells from attacking their brain and spinal cord.
Dr. Deb Muth 38:02
And so for inflammatory bowel disease, the research by Barnholm uh sorry Barnhorn and colleagues in gut in 2020 showed that MS cell MSC derived extracellular vesicles could support mucosal healing and reduce inflammation in the gut lining. They appeared to restore intestinal barrier function, healing that leaky gut and modulating local immune responses.
Dr. Deb Muth 38:30
So in clinical practice, physicians are seeing patients with autoimmune conditions, experiencing reduced disease flares, decreasing the need for imunosuppressive medications, improving energy and quality of life, and in some cases extending periods of remission. But here’s what I want you to understand.
Dr. Deb Muth 38:52
When you see these therapies for autoimmune conditions, we are supporting immune regulation and reducing inflammatory damage. We are not treating or curing the disease in a conventional sense. These therapies work best as part of a comprehensive functional medicine approach that also addresses gut health because 70% of your immune system lives in your gut and environmental triggers like mold, heavy metals, chemical toxins that can drive autoimmune responses, chronic infections that can trigger immune disregulation, stress and nervous system imbalance. And
Dr. Deb Muth 39:29
these nutritional deficiencies are necessary to help improve the immune function. So regenerative therapy without addressing root causes is like bailing water out of your boat without plugging the hole. You might get temporary relief, but the underlying problem still remains. So let’s talk about neurological conditions.
Dr. Deb Muth 39:52
And this is where the science gets truly fascinating. for traumatic brain injury and concussion. Research by Zang and colleagues in the Journal of Neurot Trauma in 2015 showed that MSC derived exoomes could reduce brain inflammation, promote neuroplasticity, that’s the brain’s ability to rewire itself and improve cognitive outcomes in animal models.
Dr. Deb Muth 40:17
The exoomes crossed the bloodb brain barrier, delivered neuroprotective proteins and microRNAs. They reduced inflammation, supported mitochondrial function in injured neurons and promoted both new blood vessels from new blood formation and neurogenesis and the birth of new neurons occurred. Neurological recovery requires a multi-systematic approach.
Dr. Deb Muth 40:42
Exoomes may support neural repair, but they work best combined with hormone optimization, growth hormone, testosterone, thyroid, pregnnolone, mitochondrial support compounds like NAD, CoQ10, PQQ, carnitine, all of those things that we use traditionally in functional medicine. Now for stroke recovery, there was research by Zinn and colleagues in the journal of extracellular vesicles that showed MSC derived exoomes reduced the size of brain damage and improved neurological recovery in animal models. There was a
Dr. Deb Muth 41:19
Parkinson’s disease study done by Kimoji and colleagues in the movement disorders in 2018 that suggested that MSSE derived exoomes could support dopamineergic neuron survival and those are the cells that die in Parkinson’s and it can help to reduce neuroinflammation. Clinically, physicians are seeing improvements in patients with postconussion syndrome, chronic traumatic brain injury, early stage cognitive decline, and other neurodeenerative conditions.
Dr. Deb Muth 41:52
These are not cures, but meaningful improvements in cognitive function, mood, energy, and quality of life. Now, let’s talk about autism spectrum disorder very carefully here because this is a very sensitive but very important topic for families. There have been several clinical trials that have explored MSC therapy for autism.
Dr. Deb Muth 42:16
Liv and colleagues published research in stem cell translational medicine in 2013 showing improvements in social interaction, communication, and behavioral symptoms in children with ASD who received cord blood MSC’s. Dawson and colleagues in 2017 conducted randomized trial autotogus cord blood infusion and found modest improvements in social communication particularly in children with higher baseline immune dysregulation.
Dr. Deb Muth 42:47
The proposed mechanisms for modulation of neuroinflammation support the mitochondrial function because many children with autism show evidence of mitochondrial dysfunction, reduction of oxidative stress, improvement in gut brain access dysfunction and modulation of immune dysregulation. In clinical practice, some physicians are seeing improvements in some children, better eye contact, increased language development, reduced sensory sensitivities, improved social engagement, but responses vary significantly, and we cannot predict which children will benefit most. So for
Dr. Deb Muth 43:26
families considering regenerative approaches for autism, these therapies are supporting the body’s healing mechanisms, reducing neuroinflammation, supporting cellular energy production, modulating immune function. These should only be considered as part of a comprehensive biomedical approach that includes dietary interventions to address food sensitivities, support gut health, environmental toxin removal, particularly heavy metals and chemical exposures, gut healing protocols with targeted probiotics and nutrients,
Dr. Deb Muth 44:00
metabolic testing and targeted supplementation, and evidence-based on behavioral and developmental therapies. These therapies should only be pursued with practitioners who are honest about what we know and what we don’t know and who follow rigorous safety protocols who never promise cures and who view regenerative medicine as a tool in the comprehensive healing strategy, not a standalone miracle.
Dr. Deb Muth 44:26
Not only that, these therapies will most likely need to be given several times over the course of this person’s lifetime, possibly even on an annual basis. And this is really important because it is not a oneandone. It is not a one-sizefits-all, and it needs to be looked at as a long-term option for working with autism. So, since we’re looking at stem cells versus exoomes, living cells, with stem cell therapy, you’re receiving living cells that can survive in your body for days to weeks.
Dr. Deb Muth 45:02
With exoome therapy, there are no living cells, just biological messages they would have sent. So, replication stem cells can potentially replicate. Although therapeutically this happens minimally, exoomes cannot replicate. They deliver the cargo and then they are cleared by your body. With stem cells, it’s primarily paracrine signaling.
Dr. Deb Muth 45:28
They’re coaching your cells to heal. With exoomes, it’s pure signaling, pure reprogramming your cells without any cellular component. Stem cells as we talked about can be autotogus from your own bone fat, blood or um bone marrow or allergenic from umbilical cord tissue or Wharton’s jelly.
Dr. Deb Muth 45:50
Exoomes are typically derived from cultured MSC’s often from umbilical cord or bone marrow sources and both can be given by local injection for targeted treatment of joints and tissues and exoomes can be given intravenously for whole body systemic support. both have um low immun immunogicity. I can’t say that word today.
Dr. Deb Muth 46:17
But exoomes have even lower risk since they contain no cellular material. Now, it’s absolutely critical for you to understand that there are massive quality differences. We’ve talked about this earlier. I want you to be very aware of this and have a conversation with any of the practitioners that you’re considering undergoing this treatment with.
Dr. Deb Muth 46:37
Here is where it matters more than anything when you’re considering regenerative medicine, the quality of the products and the expertise of the practitioner. Because the reality is not all regenerative medicine products are created equal. We all know that when we take different supplements and not all practitioners understand these therapies at the same depth.
Dr. Deb Muth 46:58
You want to look for practitioners that are board certified or have some kind of specialized regenerative medicine training. You want to know their clinical experience. How much have they done these procedures? How long have they done this? You want honest communication about the evidence and the limitations in this.
Dr. Deb Muth 47:17
You want a comprehensive functional medicine approach to go along with these therapies. And you want somebody that’s transparent about their informed consent and their regulatory status. If you have people that are uh claiming that they can cure disease or giving you guarantees, that is not that is not a good practitioner to work with.
Dr. Deb Muth 47:37
If you have high pressure sales tactics, you need to decide today limited supply for a week. These are marketing manipulations. It’s not medical care. You want to be cautious of extremely low prices because quality regenerative products are expensive to source, process, and test. and store. And if somebody’s offering stem cells or exoomes for a few hundred dollars, seriously, you need to question the quality, the safety, and where they got this from.
Dr. Deb Muth 48:09
So before undergoing any regenerative therapy, make sure you’re having a very, very lengthy conversation with the person and so you truly understand exactly what you’re getting, how it’s going to be delivered, and what they’re going to do. If there’s one thing I want you to take away from today is that your body has remarkable capacity to heal when given the right biological signals and the right environment.
Dr. Deb Muth 48:35
Stem cells and exoomes are powerful tools for providing biological signaling that can reduce inflammation, modulate immune function, support tissue repair, and restore cellular communication that’s been disrupted by chronic disease and inflammation. These therapies are available in the United States through trained physicians working in FDA registered trials, observational studies, and clinical practice, and using quality products from manufacturers with rigorous testing and quality control.
Dr. Deb Muth 49:04
So before you invest in regenerative medicine, do your homework. Ask detailed questions about product quality and source. Verify the products come from reputable manufacturers with certificates of analysis, third-party testing. Work with experienced practitioners. And remember, no injection, no infusion, no biologic can overcome ongoing toxic exposure, chronic stress, poor nutrition, gut dysfunction, and inadequate sleep.
Dr. Deb Muth 49:34
True healing requires your body and you to actively participate in this healing. If you are unwilling to address the root causes and change the lifestyle factors that disrupted your health in the first place, the biologics can amplify your healing signals, but you have to create the internal environment where healing can actually happen.
Dr. Deb Muth 49:56
So, I hope this episode has helped you understand regenerative medicine more clearly. Share it with somebody who’s looking for healing beyond the conventional approaches. And until next time, this has been Let’s Talk Wellness Now. Have a blessed day. >> Welcome to Let’s Talk Wellness Now, where we bring expert insights directly to you.
Dr. Deb Muth 50:16
Please note that the views and information shared by our guests are their own and do not necessarily reflect those of Let’s Talk Wellness Now, its management, or our partners. Each affiliate, sponsor, and partner is an independent entity with its own perspectives. Today’s content is provided forformational and educational purposes only and should not be considered specific advice, whether financial, medical, or legal.
Dr. Deb Muth 50:41
While we strive to present accurate and useful information, we cannot guarantee its completeness or relevance to your unique circumstances. We encourage you to consult with a qualified professional to address your individual needs. Your use of information from this broadcast is entirely at your own risk.
Dr. Deb Muth 51:00
By continuing to listen, you agree to indemnify and hold Let’s Talk Wellness Now and its associates harmless from any claims or damages arising from the use of this content. We may update this disclaimer at any time, and changes will take effect immediately upon posting or broadcast. Thank you for tuning in. We hope you find this episode both insightful and thought-provoking. Listener discretion is advised.