Regulatory gaps in unproven stem cell interventions: case reports and call for FDA enforcement

Researchers reviewed published case reports and information about commercial clinics offering unapproved stem cell treatments. The report included patients who received these treatments outside well-tested clinical trials. In some cases, people developed serious problems, including severe eye damage and vision loss after injections marketed for eye disease. The researchers argued that regulators needed to enforce existing safety rules more strongly. This report did not test whether stem cell treatments work.

What this means for you: Unapproved stem cell treatments can be dangerous, and marketing claims are not proof of safety or effectiveness. Be very cautious about paying for these treatments unless they are part of a properly approved clinical trial.