Multi-State Stem Cell Law Updates: What Changed on July 1, 2026
On July 1, 2026, Wyoming’s Stem Cell Freedom Act took effect, adding another state to the patchwork of laws governing non-FDA-approved stem cell therapy. For physicians tracking this landscape, the practical questions are what actually changed, what stayed the same, and what none of these laws do. This update covers the July 1 change, the […]
What Informed Consent for Adipose Banking Actually Covers
Patients are often asked to sign a consent form right before banking, and many sign without fully understanding what they are agreeing to. This guide explains what a banking consent form should and should not say, the elements a legitimate form contains, the state disclosure laws a patient may encounter, and the red flags that […]
Right to Try vs. Expanded Access: What Patients Actually Need to Know
Patients researching options beyond approved care often encounter two terms, Right to Try and expanded access, and assume they are interchangeable shortcuts to investigational therapy. They are neither interchangeable nor shortcuts. This guide explains what each actually requires, how they compare with a clinical trial, and why banking a person’s own tissue fits neither pathway […]
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 […]