| Autor: |
Rosskopf, Konrad, Ragg, Scott J., Worel, Nina, Grommé, M., Preijers, Fwmb, Braakman, E., Schuurhuis, Gj, Van Riet, Ivan, Wendel, Silvano, Fontão-Wendel, Rita, Lazar, Arlete, Goldman, Mindy |
| Přispěvatelé: |
Hematology |
| Jazyk: |
angličtina |
| Rok vydání: |
2011 |
| Předmět: |
|
| Popis: |
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 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. The most common cell viability test is still trypan blue dye exclusion, although its predictive value is low and it does not seem to be a substitute for assays evaluating in vitro proliferative capacity. Stem cell culture assays are time consuming and results are investigator-dependent. Furthermore, flow cytometry-based evaluation of viability or apoptosis markers of progenitor cells after freezingthawing are not standardized. Reduced numbers of viable CD34(+) cells have been reported to be associated with a risk of delayed platelet engraftment or graft failure. Further it has to be mentioned that interlaboratory discrepancies in the results of the assays exists, due to the fact that standardization is difficult and that the performance is variable. These problems can only be overcome by participating in external proficiency testing and by individual validation studies to establish specifications for release in each centre. In Germany the Societies of Transfusion Medicine, Haematology and Oncology and Paediatric Oncology and Haematology concluded that short-term culture assays are not suitable for defining the quality of the individual product but help validating the progenitor cell processing. This International Forum of Vox Sanguinis is meant to obtain information concerning the above mentioned issues. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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