A 41-site clinical trial, testing the restorative effect that adult bone marrow stem cells have on damaged or injured myocardium in heart attack patients, is being led at Wake Forest Baptist by Sanjay Gandhi, MD.
Phase I of the research study found that stem cells derived from bone marrow (mesenchymal stem cells) were safe for patients and may have the ability to limit scar formation, improve heart function and preserve tissue following a first heart attack.
Phase I was a multicenter study of 53 patients which demonstrated that the treatment was safe in adults, and those patients given this
Are any stem cell treatments approved in the U.S.?
FDA has not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications including certain blood cancers and some inherited metabolic and immune system disorders.
What should consumers know before being treated with therapies derived from stem cells?
As is the case with any investigational treatment, consumers should speak with their doctor to learn about the potential risks and benefits from being treated with a stem cell-based product. Consumers should seek assurance from their treating physician that necessary FDA approval has been