FDA’s January 2026 CMC Flexibility for Cell and Gene Therapies: What It Means for the ADSC Pipeline
On January 11, 2026, the FDA released final guidance describing a flexible approach to chemistry, manufacturing, and controls requirements for cell and gene therapy products being developed toward a biologics license application. CMC has long been one of the practical bottlenecks slowing cell therapies from late-stage trials to approval, so the guidance is worth understanding […]
Active Clinical Trials Using Adipose-Derived MSCs: A 2026 Physician Reference
The clinical case for banking autologous adipose tissue rests on a research pipeline, and that pipeline is best understood from primary sources rather than summaries. As of 2026, active trials are studying adipose-derived mesenchymal stem cells across several condition categories, from neurodegenerative disease to musculoskeletal and inflammatory conditions. What follows is a physician reference to […]
Adipose Banking and the Orthopedic Physician: Harvest Documentation, Consent, and the SB 1768 Scope
Florida SB 1768 names orthopedic conditions as one of only three categories within its authorized scope for non-FDA-approved stem cell therapy, alongside wound care and pain management. That places orthopedic surgeons and sports medicine physicians in Florida closer to the center of the state’s framework than any other specialty. For a physician already harvesting adipose […]
FDA Warning Letters in Regenerative Medicine: The Pattern Physicians Must Recognize
The FDA has issued warning letters to stem cell and HCT/P providers for years, and the violations cited fall into a recognizable pattern, almost all of them rooted in 21 CFR Part 1271. Reading that pattern is more useful to a physician than memorizing any single letter, because it shows precisely what the agency looks […]
The FTC Stem Cell Enforcement Pattern: What the Stem Cell Institute of America Case Means for Every Provider
In January 2025, federal court orders permanently banned the co-founders of the Stem Cell Institute of America from marketing regenerative medicine treatments and imposed more than $5.1 million in penalties and consumer refunds. The action was brought jointly by the Federal Trade Commission and the Georgia Attorney General. For any physician who markets stem cell […]
Homologous Use: The Other 361 Criterion Physicians Cannot Ignore
Minimal manipulation gets most of the attention, but homologous use is the criterion that catches physicians off guard most often. A physician can use a properly processed, genuinely minimally manipulated tissue product and still convert it into a 351 biologic, requiring an IND, simply by using it for a purpose outside the tissue’s basic function. […]
What “Minimally Manipulated” Really Means Under 21 CFR 1271
Whether a tissue product is regulated as a 361 HCT/P, needing no pre-market approval, or as a 351 biologic, needing an IND and a BLA, turns on four cumulative criteria under 21 CFR 1271.10. “Minimally manipulated” is the first of those criteria and the most frequently litigated. Getting it wrong, or relying on a supplier […]
Informed Consent for Stem Cell Banking: What Physicians Must Document Across States
Informed consent has always been an ethical and legal baseline in medicine. In non-FDA-approved stem cell therapy, it is now also a specific statutory compliance requirement, and the elements differ by state. Florida SB 1768, Utah’s amended Section 58-1-512, and Wyoming SF 48 each condition lawful practice on a written consent that contains particular elements, […]
Current Good Tissue Practice (CGTP): The FDA Standard Your Lab Partner Must Meet
If a physician banks or processes a patient’s adipose tissue through a third-party lab, the quality of that tissue is governed by a federal standard called Current Good Tissue Practice. CGTP lives in Subpart D of 21 CFR Part 1271 and applies to every registered HCT/P establishment, including those making 361 products that need no […]
FDA Establishment Registration for HCT/P Providers: What It Is and Why It Is Not Optional
A common assumption among physicians entering regenerative medicine is that 361 HCT/Ps carry no FDA obligations because they require no pre-market approval. That is wrong, and the misunderstanding can be expensive. 21 CFR Part 1271 imposes registration, listing, and Current Good Tissue Practice requirements on every establishment that manufactures HCT/Ps, including those that qualify under […]