Afleveringen
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What happens when you mix stem cells with something extra? It might seem harmlessâadding a drug, a scaffold, or even a growth factor to enhance a treatmentâbut that simple addition can change everything. The FDAâs "No Combination" rule for 361 HCT/Ps is designed to keep human cell and tissue products from crossing into drug regulation territory. But where is the line between innovation and overregulation?In this episode, we take a deep dive into one of the most debated FDA restrictions in regenerative medicine: What counts as "mixing" stem cells with another article, and when does it turn your treatment into a drug?đŹ Key Topics Covered:â What does the FDA allow? Breaking down the rules for 361 HCT/Psâ What crosses the line? Real-world cases of stem cell mixtures flagged by the FDAâ DMSO: The 3-in-1 Chemical â A cryoprotectant, an FDA-approved drug, and even an industrial solventâ Can regenerative medicine learn from IVF? The self-regulation of the fertility industry and what it teaches us about stem cell therapyâ Patient safety vs. medical innovation â Should the FDA allow more flexibility in HCT/P regulations?đš Case Studies:â Exosome-Stem Cell Mixtures â Why clinics have been warned for these âenhancedâ therapiesâ Bone + BMP (Bone Morphogenetic Proteins) â When a natural protein turns a bone graft into a drugâ Amniotic Fluid + Growth Factors â The fine line between tissue and biologic drug classificationđĄ Is the FDA being too strict, or is this regulation necessary to protect patients? Should regenerative medicine be allowed to self-regulate like IVF clinics? Let us know what you think in the comments!đ Subscribe for more deep dives into stem cell science, regulations, and the future of regenerative medicine. Donât miss an episode!#StemCellRevolution #RegenerativeMedicine #StemCellTherapy #FDARegulations
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Weâre hitting pause on stem cell regulations to bring you a special report on Donna Changâs latest trip to HHS! Who did she meet? What was discussed? And what happens when Hope arrives in our nationâs capital? Watch now to find out!
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Zijn er afleveringen die ontbreken?
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Join us as we decode the FDA's playbook on homologous use! In this episode, we dive into the critical differences between HCT/Ps and drugs, unravel real-world examples, and explore the regulatory drama that shapes regenerative medicine. Tune in to discover how a simple definition can redefine the future of cellular therapies!Join the Conversation:Your feedback is crucial! Ask us anything in the comments about stem cell therapies and their regulation, or share your experiences.Don't forget to like, subscribe, and hit the bell icon for more updates on stem cell research and its revolutionary potential in healthcare. Check out our website in the description below for more information or to order your exclusive "Not Plastic Bag" t-shirt!
Links:
HOPE STORE: https://www.hope.bio/merch
WEBSITE - https://www.hope.bio
INSTAGRAM - https://www.instagram.com/hope.bio/
TWITTER - https://twitter.com/hopebiosciences
FACEBOOK - https://www.facebook.com/hopebiosciences
#HopeBiosciences #StemCellResearch #YearInPhotos #Inspiration#StemCellRevolution #FDA #Regulation #MinimalManipulation #StemCellTherapy #2025
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Join us for an insightful dive into the complex world of stem cell regulation in this episode of "Stem Cell Revolution." Recorded in early 2025, we explore the pivotal topic of minimal manipulation - a cornerstone in determining whether stem cell products are classified as drugs or human cell, tissue, or cellular and tissue-based products (HCT/Ps).Key Highlights:00:00 - Intro and New Year Reflections04:23 - Why Stem Cells are Regulated as Drugs17:20 - Case Law on Minimal Manipulation27:23 - The Future of Stem Cell Regulation
Stem Cells. Bank Them. Fleece Sweatshirt: https://www.hope.bio/product-page/stem-cells-bank-them-cropped-fleece-pulloverJoin the Conversation:Your feedback is crucial! Ask us anything in the comments about stem cell therapies and their regulation, or share your experiences.Don't forget to like, subscribe, and hit the bell icon for more updates on stem cell research and its revolutionary potential in healthcare. Check out our website in the description below for more information or to order your exclusive "Not Plastic Bag" t-shirt!#StemCellRevolution #FDA #Regulation #MinimalManipulation #StemCellTherapy #2025
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Join Donna Chang and Sherry Diers for a heartfelt and entertaining journey through Donnaâs year in photos! In this episode, Donna opens up her camera roll to share the most meaningful, funny, and impactful moments of the past year.From behind-the-scenes highlights at Hope Biosciences to unforgettable milestones in groundbreaking stem cell research, this episode is packed with stories that celebrate progress, resilience, and hope. Youâll get an insider look at what itâs like to drive innovation in healthcare, from patient success stories to the incredible teamwork that makes it all possible.But itâs not all workâDonna shares personal moments that bring out the laughter and humanity behind the science. From candid snapshots to spontaneous memories, each photo tells a story of connection, determination, and the power of staying hopeful.Whether youâre passionate about medical advancements, inspired by personal growth, or just here for the feel-good vibes, this episode is sure to brighten your day.đ Donât forget to LIKE, COMMENT, and SUBSCRIBE for more inspiring content from Hope Biosciences!Links:WEBSITE - https://www.hope.bioINSTAGRAM - https://www.instagram.com/hope.bio/TWITTER - https://twitter.com/hopebiosciencesFACEBOOK - https://www.facebook.com/hopebiosciences#HopeBiosciences #StemCellResearch #YearInPhotos #Inspiration
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In this episode of Stem Cell Revolution, hosts Donna Chang and Jan Shultis return after a brief hiatus with a powerful recap of recent events and achievements in the stem cell field. They discuss Hope Biosciencesâ landmark gala event, where they successfully raised over $1 million to advance their foundationâs mission, touching on the importance of community support and the next generationâs role in this movement. The conversation then shifts to the recent clinical trial successes, including a groundbreaking multiple sclerosis study.With the legal landscape for stem cell therapy evolving, Donna and Jan dive into a topic frequently asked about by their listeners: the legality of stem cells in research and treatment. The discussion sheds light on the early history of stem cell regulations, from embryonic research restrictions to the development of guidelines governing adult stem cell research. They cover the distinct regulatory pathways for different types of stem cell products, touching on significant milestones like the National Research Act, the Dickey-Wicker Amendment, and FDAâs evolving oversight role.Stay tuned for a deeper look at these complexities, as Donna and Jan aim to clarify the ongoing regulatory journey that shapes stem cell research and therapy today.Links:WEBSITE - https://www.hope.bioINSTAGRAM - https://www.instagram.com/hope.bio/TWITTER - https://twitter.com/hopebiosciencesFACEBOOK - https://www.facebook.com/hopebiosciences
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In this episode of Stem Cell Revolution, host Donna Chang engages in a fascinating discussion with Sherry Diers about the groundbreaking world of mesenchymal stem cells (MSCs). The conversation delves into the fundamental differences between MSCs and hematopoietic stem cells, explaining that while hematopoietic stem cells need to be matched to prevent rejection, MSCs are remarkably adaptable and can be sourced from any donor without the same risk of immune rejection.Sherry and Donna explore how MSCs have shown significant promise in animal trials and numerous clinical studies, citing over 1200 trials with a large number achieving positive results. Despite this, MSCs are still awaiting broader approval in the U.S., leading to a deeper investigation into why many pivotal phase three trials have failed. They discuss the inherent challenges in scaling trials, variability in patient responses, and the difficulties in maintaining cell consistency across large trials.The conversation also touches on the challenges associated with autologous MSCs, including donor-to-donor variability and the complexities of scaling up production. Sherry and Donna examine the issues surrounding allogeneic MSCs, such as the need for consistent donor cell quality and the difficulties in mass production and preservation.The episode highlights the impressive safety record of MSCs and their potential in treating various conditions, including immune system disorders and cancer. Donna emphasizes that while MSCs have shown tremendous potential, the focus now is on resolving the technical challenges to fully harness their therapeutic capabilities. The discussion concludes with a hopeful outlook on the future of MSCs, emphasizing their role in treating, preventing, and potentially revolutionizing healthcare.Tune in to Stem Cell Revolution for an insightful exploration of the cutting-edge field of stem cell therapy and the promising future of MSCs.
Links:
WEBSITE - https://www.hope.bio
INSTAGRAM -https://www.instagram.com/hope.bio/
TWITTER - https://twitter.com/hopebiosciences
FACEBOOK -https://www.facebook.com/hopebiosciences
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Welcome to another episode of the Stem Cell Revolution podcast, hosted by Donna Chang, Founder and CEO of Hope Biosciences. In this enlightening episode, Donna sits down with Jan Shultis to delve into the transformative world of stem cell therapy and the unique journey of Hope Biosciences.In This Episode:1. The Origin Story of Hope BiosciencesDonna and Jan discuss the unconventional beginnings of Hope Biosciences. Donna shares how the company was built not with traditional business models in mind but with a vision rooted in innovation, faith, and a commitment to people-centered care. They explore the unexpected paths and challenges faced in developing their groundbreaking technology.2. The Personal Touch Behind the TechnologyThe conversation highlights the deeply personal motivations driving Hope Biosciences' mission. Donna and Jan reflect on their roles as mothers and their aspirations for their childrenâs future health, emphasizing the importance of creating a legacy of advanced, accessible medical treatments.3. Innovations in Stem Cell TherapyDonna and Jan break down the science behind Hope Biosciences' approach to stem cell therapy. They discuss their core technology, which focuses on using mesenchymal stem cells (MSCs) sourced from fat tissue to produce large quantities of high-quality cells. This approach aims to revolutionize treatment for chronic diseases and potentially pave the way for future medical advancements.4. The Future of Stem Cell TechnologyThe episode touches on the exciting possibilities of stem cell research, including the potential for regenerative medicine to address a wide range of health issues. Donna and Jan envision a future where preventive cell therapy becomes a cornerstone of healthcare, reducing the burden of chronic diseases and improving overall quality of life.5. The Personal and Professional ImpactDonna and Jan discuss the intersection of their professional passion with their personal lives. They reflect on the dedication required to drive forward this pioneering technology and the rewarding impact of making a difference in patientsâ lives.6. What's Next for Hope BiosciencesThe conversation wraps up with a look at future developments, including upcoming clinical trials and the continued commitment to advancing stem cell technology. Donna and Jan invite listeners to stay engaged with their journey and follow their updates.Stay Connected:Subscribe to the Stem Cell Revolution podcast for more inspiring stories and updates on stem cell research.Check out the Hope Biosciences Foundation's monthly updates for the latest in clinical trials and patient stories.Join Donna and Jan as they explore the revolutionary field of stem cell therapy and its potential to reshape the future of healthcare.Links:WEBSITE - https://www.hope.bioINSTAGRAM - https://www.instagram.com/hope.bio/TWITTER - https://twitter.com/hopebiosciencesFACEBOOK - https://www.facebook.com/hopebiosciences
