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