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 stem cell therapy actually experienced improvement in their overall ejection fraction. The earlier phase of the study showed that these mesenchymal stem cells could target the damaged myocardial tissue and initiate a process for recovery of heart muscle that could hopefully result in improvement of the overall heart.
Wake Forest is currently participating in a Phase II multicenter study investigating the efficacy of a one-time infusion of adult bone marrow stem cells in heart attack patients. Patients who experience a first time heart attack and undergo coronary angioplasty and stenting are eligible. Investigators are studying whether treatment with stem cells results in less heart muscle damage and improved heart function following a heart attack.
Wake Forest Baptist is the only trial site in North Carolina, South Carolina, Virginia and West Virginia.