What is Regenerative Cell Therapy?

Regenerative cellular therapy—which involves the replacement or regeneration of human cells or tissues to restore or establish normal function in the human body—represents the next generation of groundbreaking treatments that are showing great promise in cardiology, neurology, oncology, orthopedics, ophthalmology, and other areas. Research is also now underway to explore the use of regenerative cell therapies to help patients with Alzheimer’s disease, cancer, cerebral palsy, diabetes, and Parkinson’s disease.

What Actions are Needed?

The FDA’s implementation of the Regenerative Medicine Advanced Therapy program in response to the 21st Century Cures Act is bringing safe and effective regenerative cell therapies to patients. The next important step is to establish a national outcomes database or registry to measure patient outcomes, safety, and effectiveness.

Such a registry – which would only include either FDA-approved products or products under an FDA-administered IND or IDE – would support the measurement and improvement of outcomes, advance the science, and help create a community of high-quality providers who agree to share data and be accountable to patients and the public.

Importantly, the registry will help separate quality providers from “bad actors” that administer unsafe, unapproved treatments that put patients’ health at risk.