期刊
CYTOTHERAPY
卷 12, 期 3, 页码 338-348出版社
INFORMA HEALTHCARE
DOI: 10.3109/14653241003695034
关键词
cell therapy; clinical-scale expansion; closed process; cord blood; good manufacturing practice; mononuclear cell separation; regenerative medicine; Sepax; unrestricted somatic stem cell
类别
资金
- Deutsche Forschungsgemeinschaft (DFG) [FOR 717, Ko2119/6-1]
- German Jos E Carreras Leukemia Foundation [DJCLS-R07/05v]
Background aims. The discovery of unrestricted somatic stem cells (USSC), a non-hematopoietic stem cell population, brought cord blood (CB) to the attention of regenerative medicine for defining more protocols for non-hematopoietic indications. We demonstrate that a reliable and reproducible method for good manufacturing practice (GMP)-conforming generation of USSC is possible that fulfils safety requirements as well as criteria for clinical applications, such as adherence of strict regulations on cell isolation and expansion. Methods. In order to maintain GMP conformity, the automated cell processing system Sepax (Biosafe) was implemented for mononucleated cell (MNC) separation from fresh CB. After USSC generation, clinical-scale expansion was achieved by multi-layered CellSTACKs (Costar/Corning). Infectious disease markers, pyrogen and endotoxin levels, immunophenotype, potency, genetic stability and sterility of the cell product were evaluated. Results. The MNC isolation and cell cultivation methods used led to safe and reproducible GMP-conforming USSC production while maintaining somatic stem cell character. Conclusions. Together with implemented in-process controls guaranteeing contamination-free products with adult stem cell character, USSC produced as suggested here may serve as a universal allogeneic stem cell source for future cell treatment and clinical settings.
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