CardioBrief: Cardiac Stem Cell Therapies May Get Boost from New FDA

September 15, 2017

(MedPage Today) – Cardiac stem cell therapy could gain FDA approval far earlier than most people expect, despite the fact that these therapies have consistently failed to produce any convincing evidence of safety and efficacy. Under the old FDA rules stem cell therapies would not have stood a chance of approval. Companies would have been required to demonstrate in a pivotal clinical trial that the therapy was both safe and effective.