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 licensed by the Food and Drug Administration, 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 under oversight of different centers within the FDA. As products are shipped across international boundaries, additional challenges arise due to variable regulations.
Donors of HCT/Ps must meet specific eligibility criteria outlined by FDA, accrediting organizations such as AABB and individual transplant programs. The criteria are intended to assure the donor is healthy prior to making the donation and has a safe donation experience, and that the patient receives a safe product. The eligibility criteria are very similar to those in place for blood donors (see Donor Screening and Testing), but due to the unique patient need for the HCT/P product, some differences are applicable.
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
8/9/10
FDA posts an addendum on imported human cells, tissues, and cellular and tissue-based products to be included with its compliance program guidance manual on imported products regulated by the Center for Biologics Evaluation and Research.
8/3/10
FDA posts the Tissue Reference Group's 2009 Annual Report of recommendations on the regulation of human cells, tissues, and cellular and tissue-based products. The recommendations are part of the group's mission to help facilities that process HCT/Ps determine the jurisdiction and applicable regulations under which their products fall.
1/14/10
AABB submits comments to the docket for draft IND guidance on HPC(CB).
1/1/10
FDA posts the Compliance Program Guide Addendum on Imported HCT/Ps.
Archived Actions