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ctt-journal > Shakhpazyan N.2 et al. (Abstract)

Shakhpazyan N.2 et al. (Abstract)

Cellular Therapy and Transplantation (CTT), Vol. 3, No. 12
doi: 10.3205/ctt-2011-No12-abstract40

© The Authors. This abstract is provided under the following license: Creative Commons Attribution 3.0 Unported

Abstract accepted for "5th Raisa Gorbacheva Memorial Meeting Hematopoietic Stem Cell Transplantation in Children and Adults", Saint Petersburg, Russia, September 18–20, 2011

Preliminary Program

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Biological characteristics and quality estimation of human bone marrow mesenchymal stem cells for clinical use

Nicolay K. Shakhpazyan1, Tatiana A. Astrelina1,2, Mariya V. Yakovleva1, Alexey E. Gomzyakov1, Elena V. Boyakova1,2, Elizaveta V. Kleina1, Yanna A. Kruglova1

1Stem Cell Bank, Moscow, Russia; 2Federal Research Center for Pediatric Hematology, Oncology and Immunology, Moscow, Russia

Correspondence: Tatiana A. Astrelina, Stem Cell Bank, Moscow, Russia, 31, Bakinskaya str., Moscow, 115541, Russia, E-mail: t_astrelina@spam is badmail.ru

Abstract

Aim: To estimate the quality and biological safety of human bone marrow mesenchymal stem cells (MSCs) for clinical application.

Methods: MSCs expansion was performed from 99 bone marrow samples according to the registered medical technologies in Roszdravnadzor.

Results: After expansion of bone marrow MSCs 23 samples were unfit, including 3 samples (3.1%) due to bacterial contamination, 3 samples (3.1%) due to technical reasons and 17 samples (17.3%) due to a lack of cell growth in culture. A total of 76 samples of bone marrow MSCs (163 doses) were harvested. Received MSCs were given in their native form or were cryopreserved in the cryocomplex “BioArchive®” until their use. All samples were bacteriologically and virally controlled. When positive results were identified the samples were discarded. MSCs immunophenotype were typical for cells of mesenchymal origin: CD73+, CD90+, CD105+, CD106+, CD166+, CD45-, CD34-, CD14-, CD133-, CD19-, and HLA DR-. The viability of MSCs was investigated by Trypan Blue staining (cell viability to be not less than 95%). Biological safety was evaluated at the 4–5 and 9–10 passages by karyotyping of metaphase chromosomes and interphase chromosome study X, Y, 6, 8, and 11 by fluorescent in situ hybridization. In 3 samples early passages identified clones with abnormal karyotypes (1 with trisomy 8, and 2 with monosomy X). These abnormal karyotypes remained in the cultures during expansion. In other samples the karyotype and aneuploidy levels remained unchanged after prolonged cultivation.

Conclusions: Thus, quality assurance and MSCs safety includes a strict maintenance of documentation according to GMP standards, bacteriological and viral control, confirmation of mesenchymal origin, and evaluation of biological safety.

Keywords: mesenchymal stem cells, bone marrow, biological characteristics, quality, safety