| Online-Ressource |
Verfasst von: | Aktas, Murat [VerfasserIn]  |
| Buchheiser, Anja [VerfasserIn]  |
| Houben, Amelie [VerfasserIn]  |
| Reimann, Verena [VerfasserIn]  |
| Radke, Teja [VerfasserIn]  |
| Jeltsch, Kathrin [VerfasserIn]  |
| Maier, Patrick [VerfasserIn]  |
| Zeller, W. Jens [VerfasserIn]  |
| Kogler, Gesine [VerfasserIn]  |
Titel: | Good manufacturing practice-grade production of unrestricted somatic stem cell from fresh cord blood |
Verf.angabe: | Murat Aktas, Anja Buchheiser, Amelie Houben, Verena Reimann, Teja Radke, Kathrin Jeltsch, Patrick Maier, W. Jens Zeller & Gesine Kogler |
Jahr: | 2010 |
Umfang: | 11 S. |
Fussnoten: | Elektronische Reproduktion der Druckausgabe ; Gesehen am 16.11.2022 |
Titel Quelle: | Enthalten in: Cytotherapy |
Ort Quelle: | Abingdon : Taylor & Francis Group, 1999 |
Jahr Quelle: | 2010 |
Band/Heft Quelle: | 12(2010), 3, Seite 338-348 |
ISSN Quelle: | 1477-2566 |
Abstract: | 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. |
DOI: | doi:10.3109/14653241003695034 |
URL: | Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.
Volltext ; Verlag: https://doi.org/10.3109/14653241003695034 |
| Volltext: https://www.sciencedirect.com/science/article/pii/S1465324910703960 |
| DOI: https://doi.org/10.3109/14653241003695034 |
Datenträger: | Online-Ressource |
Sprache: | eng |
Sach-SW: | cell therapy |
| clinical-scale expansion |
| closed process |
| cord blood |
| good manufacturing practice |
| mononuclear cell separation |
| regenerative medicine |
| Sepax |
| unrestricted somatic stem cell |
K10plus-PPN: | 1822658535 |
Verknüpfungen: | → Zeitschrift |
Good manufacturing practice-grade production of unrestricted somatic stem cell from fresh cord blood / Aktas, Murat [VerfasserIn]; 2010 (Online-Ressource)