4.1 Article

Characterization of the cell growth analysis for detection of immortal cellular impurities in human mesenchymal stem cells

Journal

BIOLOGICALS
Volume 43, Issue 2, Pages 146-149

Publisher

ACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD
DOI: 10.1016/j.biologicals.2014.11.007

Keywords

Regenerative medicine; Cellular therapy; Tumorigenicity; Mesenchymal stem cell; Quality; Safety

Funding

  1. Japanese Ministry of Health, Labour and Welfare [H23-SAISEI-IPPAN-005, H24-IYAKU-SHITEI-027, H25-JITSUYOKA(SAISEI)-IPPAN-008]
  2. Marketing Authorization Facilitation Program for Innovative Therapeutic Products

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The analysis of in vitro cell senescence/growth after serial passaging can be one of ways to show the absence of immortalized cells, which are frequently tumorigenic, in human cell-processed therapeutic products (hCTPs). However, the performance of the cell growth analysis for detection of the immortalized cellular impurities has never been evaluated. In the present study, we examined the growth rates of human mesenchymal stem cells (hMSCs, passage 5 (P = 5)) contaminated with various doses of HeLa cells, and compared with that of hMSCs alone. The growth rates of the contaminated hMSCs were comparable to that of hMSCs alone at P = 5, but significantly increased at P = 6 (0.1% and 0.01% HeLa) or P = 7 (0.001% HeLa) within 30 days. These findings suggest that the cell growth analysis is a simple and sensitive method to detect immortalized cellular impurities in hCTPs derived from human somatic cells. (C) 2014 The Authors. Published by Elsevier Ltd on behalf of The International Alliance for Biological Standardization.

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