Background to Stem Cell Quality, Potency and Patient Monitoring
Download the Quality Control Brochure here.
The ability of a bone marrow, mobilized peripheral blood or umbilical cord blood units to produce short- and long-term engraftment and repopulation in a patient undergoing transplantation for a blood malignancy, is the most important function of a processing laboratory.
The "quality" of the stem cells transplanted must be ensured since the patients receiving the stem cell infusion have had their hematopoietic system partially or totally ablated by radiation and cytotoxic drugs and are at increased risk of dying if the transplanted cells do not engraft and repopulate their hematopoietic system. The first human autologous bone marrow transplantation (BMT) was performed by Kurnick et al in 1958. No assays to determine the "quality" of human transplanted cells with respect to their growth and engraftment potential were available until Pike and Robinson in 1971 applied the in vitro colony forming cell assay, first published in 1966, to human cells.
The cell processing laboratory is responsible for a high quality product that is directly related to the success of the stem cell transplant. To this end, regulations and standards to ensure safety of the transplantation process are used.
On October 20, 2009, the FDA declared umbilical cord blood a drug. All cord blood banks involved in the production and manufacture of cord blood products for transplantation will (presumably) be regulated as are biopharmaceutical companies. In addition, the production of high quality cord blood units is mandated in the United States by the Stem Cell Therapeutic and Research Act of 2005.