Exosomes and cell products
FDA states no exosome products are approved. In December 2024, the FDA approved the MSC product Ryoncil for a specific pediatric graft-versus-host disease indication—not for chronic pain. Wharton’s jelly, MUSE-cell products and MSC products for orthopedic or neurologic conditions are not FDA-approved for those purposes.
FDA and Florida law
Florida Statutes §459.0127 address certain stem-cell therapies performed by osteopathic physicians and impose sourcing, informed consent and advertising conditions. The statute does not automatically remove federal FDA requirements. Treatment legality must be determined for the actual product, route and purpose.
What a registry can do
Observational research may collect information about routine care and outcomes. Registration on ClinicalTrials.gov, IRB review, supplier documentation or a clinic’s outcome registry does not in itself confer FDA authorization for an investigational biological product.
Reading health claims carefully
FDA clearance, FDA approval and investigational status are not synonymous. FTC guidance requires claims about safety and benefit to be truthful, not misleading and supported by competent and reliable scientific evidence. Testimonials and theoretical mechanisms do not substitute for controlled research.
Questions worth asking
Ask for the exact product name, intended clinical use, relevant FDA authorization or IND status, manufacturing and donor controls, known risks, alternatives, total cost and follow-up plan. Patients should speak with their treating physician and, when appropriate, their primary care clinician.