Informational · Non-commercial
A plain-English guide to FDA rules for stem cell therapy
The U.S. Food and Drug Administration regulates most stem cell products as biological drugs. This site explains what that means for patients — what's approved, what's still investigational, and how to recognize treatments being marketed outside the law.
Why FDA oversight matters for patient safety
Products are biological drugs
Most stem cell therapies meet the FDA's definition of a biological drug and must be proven safe and effective before being marketed.
Unapproved use carries real risk
The FDA has documented infections, blindness, tumors, and death linked to unapproved stem cell products administered outside clinical trials.
Approval means evidence
An FDA approval reflects controlled clinical trials, manufacturing review, and ongoing post-market monitoring — not marketing claims.
Watch: FDA stem cell rules in 3 minutes
A short overview of how the FDA classifies stem cell products and what patients should know before considering any therapy.
Watch the explainerGuides
Factual, non-promotional overviews of key topics.
What the FDA Regulates
Which stem cell products fall under FDA oversight, and why.
Approved vs Investigational
The difference between an FDA-approved therapy and one still being studied.
361 vs 351 Products
How the FDA classifies HCT/Ps — and why the category matters.
Current Approved Uses
Stem cell uses the FDA has actually approved as of today.
Clinical Trials
How legitimate stem cell research is conducted in the U.S.
Spotting Unproven Clinics
Red flags that a stem cell clinic may be operating outside FDA rules.
Questions to Ask a Clinic
Concrete questions to bring to any stem cell consultation.
Patient Safety
Known risks and adverse events tied to unapproved stem cell products.
Get plain-English FDA updates
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