Right to Try vs. Expanded Access: The Critical Differences Every Physician Must Know
Since the federal Right to Try Act was signed in 2018, the two pathways for reaching investigational therapies outside a clinical trial, Right to Try and expanded access, have often been treated as interchangeable. They are not. They differ in legal basis, FDA involvement, IRB requirements, eligibility standards, and the protections each affords, and those […]
The Physician’s Guide to Expanded Access: How to Submit a Single-Patient IND Application
When a patient with a serious or life-threatening condition cannot enroll in a clinical trial, FDA’s expanded access framework is the pathway that can authorize use of an investigational therapy outside a trial. For cell therapies specifically, the single-patient IND is the most commonly used route, and it is also the downstream mechanism that can […]
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 […]
Crohn’s Disease and Adipose-Derived Stem Cells: What the Darvadstrocel Story Tells GI Physicians
Darvadstrocel (cx601, marketed as Alofisel) was the first allogeneic adipose-derived mesenchymal stem cell therapy to receive central marketing authorization from a major regulator, when the European Commission approved it in 2018 for complex perianal fistulas in Crohn’s disease. It is also a cautionary case: the confirmatory Phase 3 trial failed in 2023, and the EU […]
Hope Biosciences and the TBI Trial: Autologous Adipose MSCs for Chronic Brain Injury (NCT05951777)
Chronic traumatic brain injury has no FDA-approved disease-modifying or regenerative therapy, leaving treatment largely supportive and rehabilitative. Hope Biosciences’ Phase 2 trial, NCT05951777, is studying the company’s autologous adipose-derived mesenchymal stem cells in chronic TBI against a saline placebo. The banking question this raises is different from the one in a rapidly progressive disease: many […]
The Mayo Clinic Multiple System Atrophy Trial: What Physicians Need to Know (NCT05167721)
Multiple system atrophy is a rare, rapidly progressive neurodegenerative disease with no disease-modifying treatment, which makes the question of preserving future options unusually pressing for the patients and physicians who face it. Mayo Clinic’s Phase 2 trial, NCT05167721, is studying autologous adipose-derived mesenchymal stem cells administered intrathecally in MSA. What follows is what treating physicians […]
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 […]
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 […]
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 […]