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Cytotherapy. 2010 May;12(3):338-48. doi: 10.3109/14653241003695034.

Good manufacturing practice-grade production of unrestricted somatic stem cell from fresh cord blood.

Author information

1
Institute for Transplantation Diagnostics and Cell Therapeutics, University of Duesseldorf Medical School, Germany.

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.

PMID:
20370349
DOI:
10.3109/14653241003695034
[Indexed for MEDLINE]

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