SAFETY FOR HUMAN CELL, TISSUE, AND CELLULAR AND TISSUE-BASED PRODUCT (HCT/P) – A HIGH PRIORITY
Because of their nature as derivatives of the human body, HCT/Ps pose a risk of transmitting communicable diseases. Some HCT/P’s include bone, ligament, skin, dura mater, Heart valves, Cornea, Lens etc. For this reason, regulations require that most cell and tissue donors be tested and screened for evidence of relevant communicable disease infection. Solid organ transplant patients (kidney, heart, liver) are also uniquely predisposed to emerging infections. Screening regulations have been developed to ensure that all cell/tissue/organ donors are properly screened and tested to prevent the transmission of communicable disease from transplanted cells or tissues.
The Molecular Virology Laboratory at Synapse offers FDA approved methodologies and techniques applicable for screening organ and tissue donors including cadaveric (non-heart-beating) donors.
Disclaimer
The FDA regulates human cells or tissues intended for implantation, transplantation, infusion, or transfer into a human recipient. These are referred to as human cells, tissue, and cellular and tissue-based products, or HCT/Ps, and are regulated under Title 21 Code of Federal Regulations (CFR), Part 1270 and 1271.
