What to Document When a Patient Asks About Stem Cell Banking: A Physician’s Compliance and Charting Guide
As stem cell banking becomes more visible in the consumer space, primary care physicians and general practitioners are increasingly fielding patient questions they did not seek out. The physician’s role here is not to sell banking; it is to keep the conversation compliant, document it, and direct the patient to appropriate resources. Handled well, this […]
Sports Medicine Physicians and Stem Cell Banking: Documentation, State Scope, and the Trial Pipeline Before July 1
Sports medicine is the specialty where the banking conversation arises most naturally. Patients are often young, healthy, and motivated to protect physical function over a long horizon, and they already understand PRP and biologic approaches, so the conceptual distance to banking is short. Two state frameworks bear directly on the specialty: Florida SB 1768 has […]
Plastic Surgeons and Adipose Banking: The Harvest Documentation and Informed Consent Checklist
Plastic surgeons already harvest adipose tissue at higher volume than any other specialty, through liposuction, lipoaspirate collection for fat grafting, and body contouring. For them, adding banking is a workflow modification rather than a new procedure: tissue that is already being removed is diverted to a banking container instead of discarded. The incremental procedural burden […]
What the Post-Thaw Viability Report Means and Why Florida SB 1768 Requires It
Florida SB 1768 requires that before stem cells are used in a patient, the physician receive and review a post-thaw viability analysis report from the accredited facility. It is one of the most operationally specific obligations in the statute, and it is frequently misunderstood as a one-time formality rather than a per-use prerequisite. What follows […]
Chain of Custody for Adipose Tissue: What Physicians Must Document from Harvest to Storage
Chain of custody is what turns a banked sample into a usable asset. A unit of adipose tissue that cannot be traced, with documentary certainty, from a specific patient through harvest, transfer, processing, and storage is a unit that a trial sponsor or treating physician may be unable to accept, regardless of how well it […]
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 […]
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 […]
