HCT/Ps
Overview
Human cells, tissues, and cellular- and tissue-based products consist of human cells or tissues and are intended for patient implantation, transplantation, infusion or transfer. These products may offer quality treatments for individuals suffering from life-threatening or debilitating conditions. While some products may already be FDA-licensed and approved, many others are currently under development. Cell-based therapies in use or undergoing evaluation include hematopoietic stem cells for the treatment of hematologic malignancies, genetic and immune disorders; expanded lymphocytes for immunotherapy and cancer treatment; and tissue engineered products for regenerative medicine and skin replacements.
The development of these and other cell-based therapies may fall into different regulatory paths and even into different centers within the Food and Drug Administration (FDA). As products are shipped across international boundaries, additional challenges arise due to variable regulations. AABB regulatory initiatives are coordinated with FDA and other regulatory agencies to assist members with interpretation and compliance with federal regulations. AABB regulatory staff advocate member positions before the FDA with the goal of informing the agency of AABB member concerns and influencing FDA policies. As both regulatory oversight and product innovation increase in cellular therapy, AABB provides regulatory support to improve patient health and increase public confidence in these new technologies.
Recent Actions:
8/8/08
AABB submits comments to the FDA in response to a draft guidance document on the considerations for allogeneic pancreatic islet cell products, applauding the agency for proposing standardized criteria for clinical trial subjects but stating that the content is “too prescriptive and encroaches on the practice of medicine.”
5/21/08
FDA releases a draft guidance document providing recommendations to manufacturers, sponsors and investigators conducting clinical studies of allogeneic pancreatic islet cell products for the treatment of Type 1 diabetes mellitus.
4/25/08
FDA publishes draft guidance on West Nile virus recommending conversion from minipool to individual donation nucleic acid testing based on one reactive donation for whole blood and blood components and year-round ID-NAT of all HCT/P donors using a licensed NAT screening test.
4/16/08
FDA releases a revised guidance document updating recommendations for certain human cells, tissues, and cellular- and tissue-based products that may have been improperly tested for communicable diseases, potentially increasing the risk of transmission.
Archived Actions