Provider verification
How to check a cell-therapy provider
Country, price and the phrase “GMP certified” do not establish that a specific product or treatment is authorised, effective or appropriate.
Verify five separate layers
- Treatment status: authorised product and indication, registered clinical trial, or private investigational use.
- Provider: current facility licence, responsible clinician and regulator.
- Manufacturing: issuing authority, scope, validity, product identity, traceability and release testing.
- Evidence: primary studies for the exact product, indication, dose and route, including limitations and adverse events.
- Commercial scope: written quotation, inclusions, follow-up, complication pathway and refund terms.
Independent guidance
- ISSCR — A Closer Look at Stem Cells
- FDA consumer guidance on unapproved regenerative products
- EMA overview of advanced-therapy medicinal products
Use the provider checklist and ask an independent physician to review the exact proposal before paying or travelling.