Accumulating data support the use of bone marrow (BM)-derived MSCs in animal models (e.g., swine) to restore cardiac function and tissue perfusion in chronic cardiac injury. Based on results obtained in swine, we are currently conducting phase I/II clinical trials to address the safety, cell type, cell dose, delivery technique, and efficacy of MSCs in patients with chronic heart failure. MSCs for these trials are isolated from harvested BM and then processed and expanded for intracardiac injection. The BM-MSCs in use for the clinical trials are of clinical grade having been processed successfully in an FDA-approved cGMP facility.
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