REGENERATIVE CELL THERAPIES

Regenerative cell therapy—which involves the use of human cells to restore healthy function in the human body—represents the next generation of groundbreaking treatments that are showing great promise in areas such as cardiology, neurology, oncology, orthopedics, ophthalmology, and others. 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.

Due to passage of the 21st Century Cures Act, including the FDA’s launch of the Regenerative Medicine Advanced Therapy (RMAT) program, the number of regenerative cell therapies being developed is increasing significantly.

The next step is to establish a method for systematically tracking health outcomes, safety, and efficacy of treatments through a national registry.

BENEFITS OF A REGISTRY

Launching a national registry for regenerative cell therapies provides many benefits:

  • Measure and improve short- and long-term outcomes for patients
  • Monitor safety of novel products undergoing testing in the clinic
  • Advance the science of cell therapy by assessing trends, identifying promising approaches, and facilitating collaboration
  • Improve development, manufacturing, and delivery of treatments by tracking clinical and patient-reported outcomes, including long-term results
  • Inform decision-making regarding coverage and payment
  • Provide another means of evidence development for regulatory decision-making (e.g., real-world evidence)
  • Create a community of high-quality providers who agree to share data and be accountable to patients and the public

The development and launch of a national registry can help separate quality providers from “bad actors” that administer unsafe, unapproved treatments that put patients’ health at risk. A federally-funded national registry should only include treatments approved by the FDA or conducted under an FDA-administered IND or IDE.

SUPPORT FOR A REGISTRY

Organizations representing scientists and researchers, patients, practitioners, and other health care organizations support the launch of a national registry for regenerative cell therapy. The latest list of supporters can be found here.

FOR MORE INFORMATION

For more information or to join the growing coalition of organizations supporting the advancement of a national registry for regenerative cell therapies, contact Janet Marchibroda, President of the Alliance for Cell Therapy Now, at jmarchibroda@celltherapyregistry.org.