Good manufacturing practice-grade production of unrestricted somatic stem cell from fresh cord blood
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...
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| Hauptverfasser: | , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
2010
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| In: |
Cytotherapy
Year: 2010, Jahrgang: 12, Heft: 3, Pages: 338-348 |
| ISSN: | 1477-2566 |
| DOI: | 10.3109/14653241003695034 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.3109/14653241003695034 Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S1465324910703960 
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| Verfasserangaben: | Murat Aktas, Anja Buchheiser, Amelie Houben, Verena Reimann, Teja Radke, Kathrin Jeltsch, Patrick Maier, W. Jens Zeller & Gesine Kogler |
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| 520 | |a 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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