Quality controls of cryopreserved haematopoietic progenitor cells (peripheral blood, cord blood, bone marrow).

摘要

The final quality control of cryopreserved progenitor cells is a successful and persistent three lineage engraftment after transplantation. Of course, the stem cell providing institution is obliged to have a program for controlling and monitoring the manufacturing of cellular therapy products before the patients' conditioning therapy is started. The FACT-JACIE Standards [1] and the Netcord/FACT Standards prescribe that the director of the institute shall define tests and procedures for measuring and assaying cellular therapy products to ensure their safety, viability and integrity and shall also ensure that products meet predetermined release specifications. This requires specifications of assays and the definition of thresholds to allow release.