Approaching Regulatory Approval of Cardiovascular Regenerative Therapy

Abstract

After 25 years of research and well over a decade after the first randomized blinded clinical trials suggested benefit of stem cell therapy on cardiac performance, the field seems no closer to clinical approval of a product, and skepticism exists about the viability of the idea that myocardial regeneration can be effected. What has kept the field from crossing the finish line of clinical approval and is the goal in site?