Washington, D.C. (December 10, 2019) – A new report released by the independent, non-profit Alliance for Cell Therapy Now, highlights the need for a national effort to measure outcomes related to regenerative cell therapies, as well as increased federal funding for research at the National Institutes for Health (NIH) and expanded capacity at the Food and Drug Administration (FDA) to support this rapidly growing field. The report is based on insights shared by several leaders during a September 2019 event on Capitol Hill hosted by Alliance for Cell Therapy Now in collaboration with the Regenerative Medicine Foundation and the Cord Blood Association.
Regenerative cell therapies represent the next generation of treatments that are showing great promise in cardiology, neurology, oncology, orthopedics, osteoarthritis, and wound healing. Several well-designed clinical trials are now being conducted under FDA-approved investigational new drug protocols. At the same time, some clinics have caused patient harm or made questionable claims, taking advantage of vulnerable patients and casting a negative light on this promising field.
The 21st Century Cures Act contained several provisions to make safe and effective regenerative cellular therapies available to patients, and the FDA and the NIH have taken several steps to advance and support the field. However, additional actions are needed to help bring safe and effective therapies to patients.
- Increasing and sustaining funding for regenerative cell therapy research and clinical trials at the NIH to advance the science and the field, which was noted by several private sector panelists.
- Increasing capacity within FDA’s Center for Biologics Evaluation and Research 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 and compliance with new regulations; and increased enforcement activities against those clinics that are causing patient harm, needs which were highlighted by private sector panelists.
- Launching a national outcomes database or registry that would 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.
- Gaining consensus on and driving adoption of standards and best practices to support the development, manufacturing, and delivery of regenerative cell therapies.
- Expanding workforce development initiatives including within technical and community colleges, to build capacity and develop a skilled, technical workforce for this growing field.
Leaders representing FDA, NIH, the Duke University School of Medicine and Cord Blood Association, the Georgia Institute of Technology, the Marcus Foundation, the Regenerative Medicine Foundation, Sanford Health, the Wake Forest Institute of Regenerative Medicine, and Alliance for Cell Therapy Now, participated in the event.
To view speaker slides and a webcast of the event, visit http://allianceforcelltherapynow.org/events/.
About the Alliance for Cell Therapy Now
Alliance for Cell Therapy Now (ACT Now) is an independent, non-profit organization devoted to advancing the availability of and access to safe and effective cell therapies for patients in need. ACT Now convenes experts and stakeholders to develop and advance sound policies that will improve the development, manufacturing, delivery, and improvement of regenerative cell therapies. See http://allianceforcelltherapynow.org/