Policy

Several actions are needed to help bring safe and effective regenerative cell therapies to patients:

  • Increase and sustain funding for regenerative cell therapy research and clinical trials at the NIH to advance the science and the field.
  • Expand the evidence base through collaborative evidence development, including the development of outcomes databases that capture both cell characterization data and outcomes, to increase understanding of the correlation of different types of cells with clinical outcomes, monitor safety, drive improvements in manufacturing and delivery, and inform regulatory evaluation and payment, as well as clinical and patient decision-making. Learn More 
  • Sustain innovations and adaptations implemented during the COVID-19 pandemic at the Food and Drug Administration (FDA) to accelerate development, review, and authorization of new therapies.
  • Increase capacity within FDA’s Center for Biologics Evaluation and Research (CBER) to respond to the growing pipeline; provide additional education, dialogue, and technical assistance for academic and research institutions, industry innovators, and practitioners, to increase understanding of regulations; and support enforcement activities against actors that are causing patient harm, needs which were highlighted by private sector panelists.
  • Advance public and private sector payment policies that support patient access to regenerative cell therapies.
  • Gain consensus on and drive adoption of standards and best practices to support the development, manufacturing, and delivery of regenerative cell therapies.
  • Expand workforce development initiatives including within technical and community colleges, to build capacity and develop a skilled, technical workforce for this growing field.