Washington, DC (March 14, 2022) – The independent, non-profit Alliance for Cell Therapy Now applauds Congress for inclusion of several important provisions within the FY 2022 Consolidated Appropriations Act that will advance the development and manufacturing of cell-based therapies. Key provisions included:
- Recognition that adult cell-based therapies hold promise for a broad range of conditions, including neurological conditions, musculoskeletal conditions, cancer, radiation damage, cardiovascular disease, diabetes, wound healing, and immunological disease, including COVID–19.
- Recognition that—while results of early clinical studies are promising—the primary barrier to advancing such therapies is the significant cost of conducting large-scale, randomized clinical trials—especially among academic and research institutions and small biotechnology companies—which are a precursor to bringing safe and effective therapies to patients.
- Encouraging NIH to support collaborative evidence development, in coordination with FDA and HRSA, to continue efforts to enhance transparency regarding outcomes from adult cellular therapies that are FDA-approved or being administered under FDA IND or IDE protocols,
- Encouraging NIH to consult outside experts, including researchers who have conducted clinical trials involving adult cell-based therapies, to inform its activities related to cell-based therapies.
- Directing NIH to develop and submit a report within 180 days of enactment of the legislation, that describes current NIH funding for adult cell-based therapies, disaggregated by Institute and Center, and plans to support and expand investments in such therapies, including description of plans to support clinical trials; the characterization, optimization, and scaling of manufacturing of cell-based therapies; and collaborative evidence development, including the development and operation of an outcomes database.
About Alliance for Cell Therapy Now
Alliance for Cell Therapy Now is an independent, non-profit organization guided by leaders representing academic and medical institutions, industry innovators, and patients, that is working to advance safe and effective regenerative medicine and cell therapies for patients in need. For more information about the Alliance, go to https://allianceforcelltherapynow.org/.