Episodes

  • Ep. 20 Guide to Stem Cell Therapy for Common Conditions

    Ep. 20 Guide to Stem Cell Therapy for Common Conditions
    Jan 27 2026
    To learn more about regenerative and restorative stem cell therapy treatments, visit stemshealthregenerativemedicine.com or schedule a consultation at our Miami Beach clinic, located at 925 W 41st St #300A, Miami Beach, FL 33140, You can also reach us by phone at (305) 677.0565. FULL TRANSCRIPT Guide to Stem Cell Therapy for Common Conditions Welcome to the STEMS Health Regenerative Medicine Podcast. I’m your host, and today we’re covering an important topic that often generates more questions than clear answers. This episode is a condition-by-condition guide to stem cell therapy - what the science currently supports, where evidence is limited or mixed, and where treatments remain largely experimental. Stem cell therapy is frequently discussed as a broad solution for many health problems. In reality, its potential benefits - and its limitations - depend heavily on the specific condition being treated. Evidence that supports one use does not automatically apply to another, even when similar types of cells are involved. The goal of today’s episode is education. Not recommendations. Not promises. Just a clearer framework for understanding how stem cell therapy is actually studied and applied across different medical conditions, so patients can ask better questions and evaluate claims more critically. Let’s start with an essential concept. Stem cell therapy is not a single treatment. It includes a range of approaches that differ based on tissue type - such as cartilage, tendon, nerve, or heart muscle - the underlying disease mechanism, the method of delivery, and the intended outcome. That outcome might be pain relief, functional improvement, immune modulation, or support for tissue signaling. Because of these differences, evidence varies widely by condition. A therapy that shows promise for joint pain may not be biologically plausible - or clinically appropriate - for neurologic or autoimmune disease. Understanding this variability is key to realistic expectations and safe decision-making. Throughout this episode, we’ll refer to three broad evidence categories. First, more established or stronger evidence. These are areas where multiple clinical studies exist and findings are relatively consistent, even though outcomes still vary and long-term data may be limited. Second, limited or mixed evidence. These include small studies, early clinical trials, or inconsistent results. Some patients may benefit, but conclusions remain uncertain. And third, primarily experimental. These applications are early-stage, often limited to laboratory research or small human trials. They are investigational and not considered standard care. It’s important to note that stronger evidence does not mean guaranteed results. And experimental does not automatically mean unsafe. These categories simply reflect how much is known - and how much remains uncertain. Now let’s look at specific conditions, starting with orthopedic and musculoskeletal uses. Orthopedic conditions are among the most commonly discussed applications of stem cell therapy. That’s largely because joints and soft tissues are structurally defined, allowing for localized delivery rather than systemic treatment. Outcomes such as pain and function are also easier to measure, and the underlying degenerative and inflammatory mechanisms are better understood. That said, evidence still varies significantly by condition. Knee osteoarthritis is one of the most studied orthopedic applications. Research has focused on pain reduction, functional improvement, and changes in the joint environment. The evidence here is moderate but mixed. Some studies report improvements in pain and mobility, particularly in earlier-stage disease. However, severity matters. Structural cartilage regeneration remains inconsistent, and results vary widely between patients. Importantly, stem cell therapy is not considered a replacement for joint replacement surgery in advanced arthritis. Other joint conditions - such as the hip, shoulder, and ankle - follow similar principles, but the research is less extensive. Evidence is generally limited to moderate, with smaller studies, fewer long-term outcomes, and greater variability due to joint mechanics and load. Expectations should remain conservative, especially in advanced degeneration. Tendon and ligament injuries are another area of interest because these tissues heal slowly due to limited blood supply. Research has explored whether stem cell therapy may help support the healing environment. Evidence here is limited and condition-specific. Some early studies suggest potential benefit, but outcomes depend heavily on injury severity, how long the injury has been present, and adherence to rehabilitation. Spine and disc-related conditions are more complex. Research has focused on disc degeneration, pain modulation, and local inflammation. Evidence is early and mixed. Stem cell therapy does not address structural compression or ...
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    11 mins
  • Ep. 19 Joe Rogan Talks About Stem Cell Treatment in Mexico - So What’s the Case for Care in the U.S.?

    Ep. 19 Joe Rogan Talks About Stem Cell Treatment in Mexico - So What’s the Case for Care in the U.S.?
    Jan 23 2026
    To learn more about regenerative and restorative stem cell therapy treatments, visit stemshealthregenerativemedicine.com or schedule a consultation at our Miami Beach clinic, located at 925 W 41st St #300A, Miami Beach, FL 33140, You can also reach us by phone at (305) 677.0565. FULL TRANSCRIPT Joe Rogan Talks About Stem Cell Treatment in Mexico - So What’s the Case for Care in the U.S.? Welcome to the STEMS Health Regenerative Medicine Podcast. In today’s episode, we’re addressing a topic that often comes up in popular media and online discussions: Joe Rogan talking about stem cell treatment in Mexico - and what that means for patients considering care in the United States. Conversations about stem cell therapy don’t just happen in medical journals anymore. They show up in podcasts, social media, and personal stories shared by athletes, celebrities, and public figures. Joe Rogan has been one of the most influential voices bringing attention to stem cell treatment abroad, particularly in Mexico. That visibility has helped raise awareness, especially among people frustrated by chronic pain, injuries, or slow recovery. But awareness alone doesn’t answer the most important question for patients: where is the safest and most appropriate place to receive care? The answer isn’t simply Mexico or the United States. It’s about understanding tradeoffs, evidence, and accountability. So let’s break this down clearly. When Joe Rogan talks about stem cell therapy in Mexico, he’s usually pointing to a few consistent themes. The first is access and speed. In many cases, biologic treatments are available more quickly outside the U.S., with fewer regulatory hurdles. The second is personal stories. Rogan often references athletes or public figures who report improvement after treatment abroad. And the third is frustration with bureaucracy. Like many patients, he has expressed skepticism about how long it can take for new medical approaches to become widely available in the United States. These points resonate because they reflect real patient frustration. People dealing with pain or functional limitations often feel stuck between “nothing left to try” and “nothing approved yet.” But when patients decide to seek treatment abroad, they’re making choices that involve more than access alone. Medical tourism can offer options that aren’t widely available in the U.S., but it also comes with tradeoffs that aren’t always discussed. Patients who go abroad may encounter different regulatory standards, less consistent outcome reporting, and limited long-term follow-up once they return home. Many success stories shared publicly are anecdotal and short-term. They may reflect genuine individual experiences, but they don’t always show how a treatment performs across a broader patient population or over longer periods of time. This doesn’t mean overseas care is inherently unsafe or ineffective. It does mean that patients should understand what protections, safeguards, and accountability structures may differ. Now let’s talk about the case for stem cell care in the United States. U.S.-based stem cell care is often described as conservative - and that conservatism can be frustrating. But it also reflects a system designed around accountability and patient protection. Clinics operating in the U.S. are typically required to meet standards that include oversight by licensed physicians, formal informed consent that discloses when treatments are investigational, clear documentation of cell sourcing, handling, and delivery, and defined plans for follow-up care and complication management. Another important factor is continuity of care. Receiving treatment close to home makes it easier to coordinate with primary care providers, specialists, physical therapists, and rehabilitation teams if issues arise. For some patients, these safeguards outweigh the appeal of faster access. At its core, Joe Rogan’s commentary highlights a real tension in modern medicine: regulation versus access. Regulation can slow innovation and limit availability. But it also enforces standards around safety, advertising claims, and patient disclosure. U.S. clinics are generally required to be more cautious in how they describe expected outcomes and risks. They’re held to stricter standards when it comes to documentation, informed consent, and claims made to patients. So the real decision many patients face isn’t about geography. It’s about risk tolerance. Some people prioritize speed and flexibility. Others prioritize structure, oversight, and recourse if something goes wrong. Instead of asking, “Should I go to Mexico or stay in the U.S.?” a better set of questions might be: Who is overseeing my care? What evidence exists for my specific condition? Is this treatment considered standard, investigational, or experimental? How are risks explained to me? And what follow-up care is available if problems arise? These questions...
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    7 mins
  • Ep. 18 Guide to Evaluating a Stem Cell Clinic

    Ep. 18 Guide to Evaluating a Stem Cell Clinic
    Jan 21 2026
    To learn more about regenerative and restorative stem cell therapy treatments, visit stemshealthregenerativemedicine.com or schedule a consultation at our Miami Beach clinic, located at 925 W 41st St #300A, Miami Beach, FL 33140, You can also reach us by phone at (305) 677.0565. FULL TRANSCRIPT - Guide to Evaluating a Stem Cell Clinic Welcome to the STEMS Health Regenerative Medicine Podcast. Today’s episode is a patient-education guide to evaluating a stem cell clinic - focused on due diligence, safety, and informed decision-making. Stem cell therapy is increasingly discussed as an option in regenerative medicine, especially for joint pain, musculoskeletal injuries, and degenerative conditions. At the same time, clinics offering stem cell-based treatments can vary widely in medical oversight, transparency, and standards of care. Our purpose today is not to promote treatment or discourage it. The goal is to help patients ask better questions, recognize red flags, and understand what responsible regenerative care should include. Let’s start with why evaluating a clinic matters. Stem cell therapy is not a single, standardized treatment. It can involve different cell sources, processing methods, delivery techniques, and regulatory pathways. And for many conditions, applications are still considered investigational. Because of that, clinics may differ significantly in medical oversight, provider credentials, whether they participate in clinical trials, how they explain evidence, how they handle regulatory disclosures, how they price treatment, and what follow-up care they provide. These differences directly affect patient safety, expectations, and outcomes. A careful evaluation helps patients distinguish between evidence-informed care and marketing-driven claims. The first place to start is medical oversight and provider credentials. A foundational question is simple: who is making the medical decisions? Stem cell-based care should be overseen by licensed medical providers - typically physicians - who are responsible for evaluating the patient, diagnosing the condition, determining whether regenerative therapy is appropriate, performing or supervising procedures, and managing follow-up care and complications. As a patient, you should be able to clearly identify the licensed physician directing care, confirm that provider’s state medical license, understand their clinical role and scope of practice, and know who performs evaluations versus who is handling administrative tasks. Clinics operating primarily as wellness centers or sales organizations - rather than medical practices - may not provide the level of oversight appropriate for biologic therapies. That leads to an important question: who is actually making clinical decisions? Patients should clarify whether recommendations come from a licensed physician after an evaluation, or from non-clinical staff following preset protocols. Red flags include treatment plans presented before medical evaluation, one-size-fits-all protocols applied to all patients, and sales consultations that replace physician visits. Medical decisions should be made by clinicians, not by marketing or administrative teams. Next, let’s talk about clinical trials and research context. Some stem cell clinics participate in registered clinical trials. Others offer treatments that are informed by research but not part of a trial. These are not the same thing, and clinics should clearly explain the difference. Clinical trial registration can support transparency, ethical oversight, and defined outcome tracking. But not all legitimate care occurs within a trial setting. What matters most is honest disclosure of where a treatment falls on the research-to-practice spectrum. Patients can ask: is the clinic participating in a registered clinical trial? If so, where is it registered - such as ClinicalTrials dot gov? And does the clinic’s description match what the trial listing actually says? It’s also important to understand that registration does not guarantee effectiveness. It only indicates that the treatment is being studied under defined conditions. Now let’s address a common language trap: “research-based” versus “research-proven.” These terms are often used interchangeably, but they mean very different things. Research-based usually means a treatment is informed by scientific studies - often early-stage studies. Research-proven suggests consistent clinical evidence and broader acceptance. A responsible clinic should be willing to explain what level of evidence exists, what is still uncertain, and how that uncertainty is communicated to patients. Next is published data and evidence transparency. Not all stem cell applications have extensive published data, especially for emerging uses. That’s not automatically a problem - but how a clinic discusses evidence matters. Patients should understand the difference between peer-reviewed studies, case reports or ...
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    11 mins
  • Ep. 17 Guide to How Stem Cell Therapy Works

    Ep. 17 Guide to How Stem Cell Therapy Works
    Jan 19 2026
    FULL TRANSCRIPT Welcome to the STEMS Health Regenerative Medicine Podcast. In today’s episode, we’re taking a clear, step-by-step look at how stem cell therapy actually works in real clinical settings. Not as a single treatment, not as a promise - but as a medical workflow. Stem cell therapy is often discussed as one idea, but in practice it’s a multi-step process. Outcomes are influenced not just by the cells themselves, but by how those cells are sourced, handled, delivered, and how the body responds afterward. The goal of this episode is education. We’ll walk through the full process in plain language - from evaluation and sourcing, to lab handling, delivery, and what happens inside the body - without overpromising results. Let’s begin with what “stem cell therapy” means in practical terms. In clinical care, stem cell therapy refers to the use of biologic cells or cell-derived materials as part of a regenerative treatment plan. That plan may involve different cell sources, processing methods, and delivery routes depending on the condition being addressed. Importantly, stem cell therapy is not a single standardized treatment. Two patients may both be described as receiving stem cell-based care, yet their workflows - from sourcing to delivery - may be very different. Understanding those differences helps patients ask informed questions and better interpret clinic claims. Now let’s walk through the typical workflow. Step one is patient evaluation and treatment planning. Before any discussion of cells, regenerative care begins with a medical evaluation. Clinicians assess whether stem cell-based approaches are being considered and whether a patient may be an appropriate candidate. This evaluation usually includes a review of medical history and current medications, a physical exam focused on pain, mobility, and function, imaging such as X-ray, MRI, or ultrasound when appropriate, and discussion of prior treatments and how the patient responded. The goal is not to sell a therapy. It’s to understand the underlying problem. Structural damage, inflammation, and degenerative changes can behave very differently - even when symptoms look similar. Baseline measurements like pain scores, range of motion, and activity limitations are often documented so progress can be evaluated over time. Stem cell therapy is most often discussed for musculoskeletal concerns such as joint pain, tendon or ligament injuries, and certain spine-related conditions. Clinicians also screen for situations where regenerative therapies may not be appropriate, such as active infection, systemic illness, or conditions requiring immediate surgery. Imaging matters here. Ultrasound, in particular, allows clinicians to visualize soft tissues and joints in real time and helps guide accurate delivery when injections are used. Step two is stem cell sourcing - where the cells come from. Broadly, stem cells fall into two categories based on origin: autologous and allogeneic. Autologous stem cells come from the patient’s own tissue. Common sources include bone marrow and adipose, or fat tissue. These tissues contain adult stem cells along with supportive cells. Because the cells come from the patient, compatibility concerns are minimized. Autologous workflows often occur on the same day, where cells are collected, processed, and delivered during a single visit, depending on protocol. From a patient’s perspective, this step is best understood as a collection process rather than surgery. Clinicians explain what to expect during consultation. Allogeneic stem cells come from screened donors. These cells are processed and stored according to established standards before being distributed for clinical or research use. Donor screening, testing, and documentation are central to this approach. Allogeneic products may be considered when standardization, availability, or logistics are prioritized. Regardless of source, clinics should clearly explain whether cells are patient-derived or donor-derived, and why that source is being considered. Chain of custody is also important. This refers to tracking and documentation of biologic material from collection through delivery, supporting safety, traceability, and accountability. Step three is laboratory processing and handling. After sourcing, cells undergo processing. Processing doesn’t mean the same thing everywhere. It can range from minimal preparation to more complex lab workflows conducted in regulated environments. At a high level, processing prepares biologic material for safe and consistent delivery. Cell isolation separates specific cellular components from collected tissue. Concentration increases the proportion of target cells in a sample. These steps help standardize what is delivered, rather than injecting raw tissue. Quality controls - such as viability checks, sterility practices, and time and temperature controls - play a major role in safety and consistency, even though ...
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    12 mins
  • Ep. 16 Guide to Stem Cell Therapy Basics

    Ep. 16 Guide to Stem Cell Therapy Basics
    Jan 16 2026
    To learn more about regenerative and restorative stem cell therapy treatments, visit stemshealthregenerativemedicine.com or schedule a consultation at our Miami Beach clinic, located at 925 W 41st St #300A, Miami Beach, FL 33140, You can also reach us by phone at (305) 677.0565. FULL Transcript Welcome to the STEMS Health Regenerative Medicine Podcast. In this episode, we’re walking through a practical, step-by-step guide to how stem cell therapy actually works - from initial evaluation, to cell sourcing, to delivery, and finally to what happens inside the body afterward. Stem cell therapy is often discussed as a single idea. But in real clinical settings, it’s a multi-step medical workflow. Outcomes are influenced not just by the cells themselves, but by how those cells are sourced, handled, delivered, and how the body responds over time. The goal of this episode is education - not promotion. We’ll explain each step in plain language, without overpromising results, so patients can better understand the process and evaluate regenerative care claims more accurately. Let’s start by clarifying what “stem cell therapy” means in practical terms. In clinical use, stem cell therapy refers to the use of biologic cells - or cell-derived materials - as part of a regenerative care plan. That plan may involve different cell sources, processing methods, and delivery routes depending on the condition being addressed. Importantly, stem cell therapy is not a single standardized treatment. Two patients may both be described as receiving stem cell-based care, yet their workflows - from sourcing to delivery - can differ substantially. Understanding those differences helps patients ask better questions and interpret claims with more clarity. Now let’s walk through the typical workflow, step by step. Step one is patient evaluation and treatment planning. Before any discussion of cells, regenerative care begins with a medical evaluation. Clinicians assess whether stem cell-based approaches are even being considered, and whether a patient may be an appropriate candidate. This evaluation typically includes a review of medical history and current medications, a physical examination focused on pain, mobility, and function, imaging studies such as X-ray, MRI, or ultrasound when appropriate, and discussion of prior treatments and how the patient responded to them. The goal is not to sell a therapy, but to understand the underlying problem. Structural damage, inflammation, and degenerative changes can behave very differently, even when symptoms appear similar. Baseline measurements - such as pain scores, range of motion, or activity limitations - are often documented so changes can be evaluated over time. Stem cell therapy is most commonly discussed for musculoskeletal concerns like joint pain, tendon or ligament injuries, and certain spine-related conditions. These discussions focus on tissue quality, inflammation, and function, rather than a diagnosis alone. Clinicians also screen for situations where regenerative therapies may not be appropriate, such as active infection, certain systemic illnesses, or conditions requiring immediate surgical intervention. Imaging plays an important role here. Ultrasound, in particular, allows clinicians to visualize soft tissues and joints in real time. When injections are used, ultrasound guidance helps confirm accurate placement and provides documentation of where biologic material is delivered. Step two is stem cell sourcing - where the cells come from. Broadly, stem cells fall into two categories based on origin: autologous and allogeneic. Autologous stem cells come from the patient’s own tissue. Commonly discussed sources include bone marrow and adipose, or fat tissue. These tissues contain populations of adult stem cells along with supportive cells. Because the cells originate from the patient, compatibility concerns are minimized. Autologous workflows often occur on the same day, where cells are collected, processed, and delivered during a single visit, depending on the protocol. From the patient’s perspective, this step is best understood as a collection process rather than surgery. Specifics vary, and clinicians explain what to expect during consultation. Allogeneic stem cells, on the other hand, are derived from screened donors. These cells are processed and stored according to established standards before being distributed for clinical or research use. Donor screening, testing, and documentation are central to this approach. Allogeneic products may be considered when standardization, availability, or logistical factors are prioritized. Regardless of source, clinics should be transparent about whether cells are patient-derived or donor-derived, and why a particular option is being discussed. Chain of custody matters at this stage. This refers to tracking and documentation of biologic material from collection through delivery. Proper labeling, handling, and ...
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    13 mins
  • Ep 15 Dr. Mari Dezawa — MUSE Cell Innovations Founder and CSO

    Ep 15 Dr. Mari Dezawa — MUSE Cell Innovations Founder and CSO
    Dec 23 2025
    A profile of Dr. Mari Dezawa, whose discovery of MUSE Cells reshaped how regenerative medicine understands stress-enduring, pluripotent-like cells and their potential to support targeted joint and spine repair. To learn more about regenerative and restorative treatments, visit stemshealthregenerativemedicine.com or schedule a consultation at our Miami Beach clinic, located at 925 W 41st St #300A, Miami Beach, FL 33140, You can also reach us by phone at (305) 677.0565. FULL TRANSCRIPT Dr. Mari Dezawa is one of the most influential figures in modern regenerative medicine. As Chief Scientific Officer of MUSE Cell Innovations and a professor at Tohoku University in Japan, she has reshaped the field through her groundbreaking discovery of MUSE Cells - multilineage-differentiating stress-enduring cells. Her work has provided a safer, more targeted alternative to embryonic and induced pluripotent stem cells, without the associated ethical or safety concerns. MUSE Cells are now at the center of a growing number of therapies focused on orthopedic and spine-related repair. So what exactly are MUSE Cells, and why do they matter? MUSE Cells are a rare type of adult stem cell found in bone marrow and umbilical cord tissue. They make up only one to two percent of mesenchymal stem cells, but they exhibit extraordinary properties. They survive harsh cellular stress. They can differentiate into all three germ layers - just like pluripotent cells. And most importantly, they do not form tumors. These characteristics are what make MUSE Cells so valuable. They offer the potential to regenerate tissue in a highly controlled way while reducing safety risks that have long slowed the adoption of stem cell-based treatments. One of the keys to understanding MUSE Cells is their identification. Dr. Dezawa’s team isolated them using a specific surface marker called SSEA-3. These cells can endure conditions that would destroy most other cells, and that’s where their name comes from: stress-enduring. They’ve been shown to differentiate into cell types across the ectodermal, mesodermal, and endodermal lines, supporting tissues ranging from nerve to muscle to cartilage. But unlike embryonic stem cells or iPSCs, they do so without forming teratomas or requiring genetic manipulation. So how do they work in practice? One of the most important clinical features of MUSE Cells is their ability to home to sites of injury. Whether delivered locally or systemically, they seek out damaged or inflamed tissue. Once there, they can either integrate and differentiate, or secrete beneficial factors that reduce inflammation and support surrounding cells. This is particularly relevant in orthopedic and spine care. Studies suggest MUSE Cells may support healing in the knees, hips, shoulders, and spine - areas where tissue damage is often slow to repair. Instead of simply reducing inflammation, they offer cellular-level restoration. This precision is what separates MUSE therapy from more traditional mesenchymal stem cell approaches. Where bulk MSCs may function broadly and non-specifically, MUSE Cells target the exact areas where healing is most needed, bringing structural support and regenerative signals. Dr. Dezawa’s work has moved beyond the lab and into clinical care. Through her partnership with MCI - Muse Cell Innovations - licensed providers are now offering MUSE Cell therapy in orthopedic settings. One such provider is STEMS Health in Miami Beach, one of only a few Florida clinics authorized to administer authentic Dezawa MUSE Cells. Treatments focus on joint and spine injections guided by ultrasound. No IV infusions are offered. Instead, therapy is highly localized, and delivered in a way that aligns with the scientific properties of the cells. As Chief Scientific Officer, Dr. Dezawa continues to lead the advancement of MUSE Cell research. Her team is working on GMP-compliant production lines, large-scale validation studies, and peer-reviewed research exploring how these cells can benefit not just orthopedics, but neurology, immunology, and more. Her legacy is still in progress. But what’s clear is that Dr. Mari Dezawa has introduced a new level of precision, safety, and therapeutic potential into regenerative medicine. Here are a few quick answers to common questions. What makes Dr. Dezawa’s discovery unique? She identified a subset of adult stem cells with pluripotent-like behavior that can aid tissue repair without the risks associated with iPSCs or embryonic stem cells. Are MUSE Cells safer than traditional pluripotent stem cells? Yes. MUSE Cells are non-tumorigenic and do not require genetic reprogramming, offering a more stable path to therapeutic use. Do they replace traditional MSCs? No. They complement them. MUSE Cells offer greater targeting and regenerative endurance, but MSCs remain useful in broader applications. Can they treat spine and joint issues? Current clinical use includes orthopedic pain, joint degeneration, ...
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    7 mins
  • Ep 14 Adult Stem Cells for Advanced Dry Macular Degeneration

    Ep 14 Adult Stem Cells for Advanced Dry Macular Degeneration
    Dec 22 2025
    A look at emerging clinical research showing how adult stem cell transplantation may offer early visual improvements and a new therapeutic pathway for patients with advanced dry AMD and geographic atrophy. To learn more about regenerative and restorative treatments, visit stemshealthregenerativemedicine.com or schedule a consultation at our Miami Beach clinic, located at 925 W 41st St #300A, Miami Beach, FL 33140, You can also reach us by phone at (305) 677.0565. FULL TRANSCRIPT Dry age-related macular degeneration, also known as dry AMD, is one of the most common causes of irreversible vision loss in adults over 65. Its advanced form, called geographic atrophy, leads to the progressive breakdown of retinal cells and has few effective treatment options. Unlike wet AMD, which can be managed with injections, advanced dry AMD lacks therapies that can restore lost vision. This has created an urgent need for new solutions - and that’s where adult stem cells may come in. Emerging research suggests that adult stem cell transplantation could offer a new path forward. Rather than simply slowing disease progression, stem cell therapies are being studied for their ability to support visual function and preserve retinal structure. Let’s take a closer look at why adult stem cells are drawing so much interest in this area. Adult stem cells, including mesenchymal stem cells and retinal progenitor cells, are known for their anti-inflammatory and immune-modulating properties. They can be ethically sourced from bone marrow or umbilical tissue and do not carry the tumor risks associated with embryonic or pluripotent stem cells. In animal models, these cells have been shown to preserve photoreceptors, reduce inflammation in the eye, and even improve visual responses. This laid the groundwork for early human trials. Several small, early-phase clinical studies have explored subretinal injections of these cells in patients with geographic atrophy. So far, results are cautiously optimistic. Most trials have reported no serious safety issues. And in some cases, participants experienced modest improvements in visual acuity or contrast sensitivity over the course of 6 to 12 months. Imaging studies have also shown stabilization in areas of retinal atrophy, suggesting the potential for real biological impact. How do these cells work? One mechanism is paracrine signaling - where the transplanted cells don’t necessarily become new retinal cells, but instead release beneficial signals. These may enhance the survival of photoreceptors, protect the retinal pigment epithelium, and regulate inflammation. In some cases, retinal progenitor cells may even integrate into retinal layers and contribute to structural repair. The preferred method of delivery is subretinal injection, placing the cells directly into the space between the retina and its supporting layer. This ensures close contact with damaged tissue while minimizing systemic exposure and the risk of unwanted cell migration. Innovations like image-guided microinjections have improved safety and precision in these procedures, reducing the risk of complications. Of course, stem cell therapy isn’t without its challenges. Ensuring consistent quality and viability of cell batches - especially for off-the-shelf or donor-based products - is critical. Long-term durability of the benefits is still being studied. And researchers are working to identify reliable biomarkers to track whether the therapy is truly working. Most trials now include rigorous visual testing, OCT imaging, and biomarker analysis over one to two years. Regulatory agencies, including the FDA, require this kind of detailed validation before allowing stem cell therapies to move into broader use. So what comes next? Larger phase 2 trials are now underway, aiming to confirm the early signals seen in smaller studies. Some research is exploring combination approaches - pairing stem cells with gene therapies or drugs that target other parts of the disease pathway. Others are looking at personalized stem cell lines for use in high-risk individuals. And with the help of AI-assisted retinal imaging, physicians may soon be able to detect changes earlier and tailor treatment more precisely to each patient. While stem cells for dry AMD are still investigational, their potential is significant. For patients with few existing options, they represent a new frontier in vision care - one focused not just on slowing loss, but on supporting real regeneration. Here are a few frequently asked questions. Are stem cells currently FDA-approved for dry AMD? No. These therapies are still being studied and are not yet approved for routine clinical use. How are the cells delivered? Most studies use subretinal injection, placing the cells directly behind the retina near areas of damage. Can stem cells actually improve vision? Some trials have shown improvements in vision and retinal structure, but larger studies are needed to confirm these ...
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    7 mins
  • Ep 13 FDA’s Evolving Pipeline of iPSC and MSC Products

    Ep 13 FDA’s Evolving Pipeline of iPSC and MSC Products
    Dec 19 2025
    An overview of how new FDA clearances for iPSC-derived and MSC-based therapies indicate growing regulatory maturity, clearer translational pathways, and expanding commercialization potential for next-generation cell products. To learn more about regenerative and restorative treatments, visit stemshealthregenerativemedicine.com or schedule a consultation at our Miami Beach clinic, located at 925 W 41st St #300A, Miami Beach, FL 33140, You can also reach us by phone at (305) 677.0565. FULL TRANSCRIPT Regenerative medicine is moving into a new era. Once dominated by experimental applications and regulatory gray zones, today’s landscape is defined by FDA-cleared products, structured trial pathways, and tighter manufacturing oversight. At the center of this shift are cell-based therapies built around two core technologies: induced pluripotent stem cells, or iPSCs, and mesenchymal stem cells, or MSCs. The FDA has already cleared dozens of therapies using or related to these cell types. This includes products like Ryoncil for pediatric graft-versus-host disease, Allocord for hematologic disorders, and MACI, used to treat cartilage injuries in the knee. These approvals signal something bigger: regulatory maturity. The FDA is actively shaping pathways to clinical use - through formal guidance, standardized testing, and accelerated programs like the Regenerative Medicine Advanced Therapy designation. Let’s break down how iPSC and MSC therapies differ and why they’re so important. iPSCs are adult cells that have been reprogrammed to act like embryonic stem cells. They can become nearly any type of cell - cardiac, neural, retinal, and more. This flexibility makes them ideal for targeted cell replacement therapies, especially in complex diseases like macular degeneration or Parkinson’s. MSCs, by contrast, are naturally multipotent. Found in bone marrow, fat, and umbilical cord tissue, these cells don’t require genetic engineering. They’re known for their ability to modulate the immune system, reduce inflammation, and support tissue repair. That makes them particularly valuable in orthopedics and inflammatory conditions. While MSCs are more common in current FDA approvals, iPSCs are gaining ground. Early-phase trials are evaluating iPSC-derived retinal cells, cardiomyocytes, and nerve-supporting cells. Many gene and cell therapies now in development incorporate iPSC technology behind the scenes. The FDA’s Center for Biologics Evaluation and Research, or CBER, has taken several steps to support these innovations. This includes guidance documents covering everything from potency testing and donor screening to good manufacturing practices. Under FDA regulations, both iPSC and MSC therapies must meet strict standards before they reach patients. That means proving cell identity, biological potency, safety, and sterility. Manufacturers are required to run viability assays, confirm genetic stability, test for contamination, and operate in certified GMP labs. For iPSCs, the risk of uncontrolled growth or tumor formation requires even more scrutiny. But regulatory clarity is only part of the story. The commercial landscape is also evolving. We’re seeing an increase in off-the-shelf allogeneic products like Ryoncil, which offer scalable access to care without requiring a custom donor for every patient. Combination therapies - pairing cells with scaffolds or delivery devices - are also becoming more common, especially in orthopedics. Another shift is happening in clinical access. Decentralized trial networks are expanding the reach of investigational therapies. Patients who don’t live near a major academic center may still be eligible to participate in early access programs. Altogether, these developments suggest that cell-based therapies are moving from niche to mainstream. For patients, this means more options and a clearer understanding of what’s available - and what’s still being studied. For providers, it means better tools, more data, and the chance to align treatment with individual patient biology. Let’s wrap up with a few key questions. What’s the difference between iPSC and MSC therapies? iPSCs are reprogrammed to become nearly any cell type and are often used in precise replacement therapies. MSCs are naturally multipotent and valued for immune modulation and tissue repair, especially in orthopedic use. Are any iPSC-based therapies FDA-approved? Most FDA-cleared therapies currently involve MSCs or related platforms. iPSC-based products are primarily in trial phases but are moving closer to approval. What is RMAT designation? The FDA’s Regenerative Medicine Advanced Therapy designation offers fast-track support for promising cell therapies showing early clinical benefit. How are these products manufactured safely? They must meet strict FDA standards for identity, potency, sterility, and safety - and must be produced in certified GMP-compliant facilities. What are today’s top uses...
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    7 mins