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FDA Stem Cell Guide

Questions to Ask Before Any Stem Cell Treatment

If you are considering a stem cell therapy, these are the questions that will quickly clarify whether an offering is on solid regulatory ground.

About the product itself

  • What is the exact name of the product you plan to administer?
  • Is this product FDA-approved for the condition I have? If so, under what license number?
  • If it is not approved, is it being administered under an active Investigational New Drug (IND) application?
  • What is the ClinicalTrials.gov NCT number of the trial I would be enrolled in?
  • Which Institutional Review Board (IRB) approved the protocol?

About the source and manufacturing

  • Where does the tissue or cells come from — my own body, a donor, cord blood, amniotic fluid, or another source?
  • How is the product processed? Is it minimally manipulated or expanded in a lab?
  • What manufacturer produces the final product, and is that facility FDA-registered?
  • What testing is done to screen for infection and confirm identity of the cells?

About evidence and outcomes

  • What peer-reviewed clinical trial data supports using this product for my condition?
  • What are the primary and secondary endpoints of that data — pain scores, imaging changes, survival?
  • What are the known risks and side effects, and how often do they occur?
  • How many patients with my condition have been treated with this specific product, and what were the outcomes?

About cost and consent

  • What is the total cost, including the product, procedure, follow-up, and any imaging?
  • Is my insurance being billed? If not, why not?
  • Am I being asked to pay for the investigational product itself? (In legitimate trials, patients typically are not.)
  • May I take the informed consent document home to review before signing?

Red-flag responses

Be cautious if the provider is unable or unwilling to answer any of the questions above, deflects to testimonials, or claims that "the FDA doesn't regulate this." Consider getting a second opinion from a physician who is not affiliated with the clinic.