Evaluation of the quality and safety of cryopreserved human multipotent mesenchymal stromal cells derived from placenta for the clinical use

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Abstract

The application of multipotent mesenchymal stromal cells (MMSC] in recent years is more widely evaluated in clinical trials. MMSC possess a number of unique features: the ability to support hematopoiesis, facilitating engraftment of HSC; immunomodulatory effects, including in regard to «graft versus host» reaction, and ability to differentiate into various cells types, that is defined their involvement in tissue and organ repair processes. The use of MMSC does not require antigenic compatibility control that leads to high potential accessibility of cell therapy. The most actively MMSC are evaluated in therapy of hematological, immunological, autoimmune, hereditary and other diseases. The aim of the study was to assess the quality and safety of cryopreserved placenta-derived MMSC prepared for clinical application. MMSC were obtained from 90 samples of placenta according to registered medical technology ФС №2010/374 от 13.10.2010. We evaluated the quality of placental MMSC by bacterial and viral control; determined the viability of cells with trypan blue and 7AAD; confirmed the immunophenotype specific for MMSC by flow cytometry. The biological safety of MMSC was analyzed by G-banding technique (15-20 metaphase chromosomes]. 72 samples of placenta-derived MMSC (193 doses] were prepared and used with HSC transplantation to 22 patients (42 MMSC doses] for optimization of HSC engraftment, prevention, control and treatment of «graft versus host» disease, liver regeneration. MMSC transfusion was performed at a dose of 2mln/kg. The results showed that allogeneic placenta-derived MMSC harvested in compliance with strict quality control were safe for clinical use and offered several significant advantages: no special invasive procedure for their tissue source explantation, high proliferative index on the 4th passage of cultivation, which allowed getting the required amount of cells for maximal therapeutic effect.

About the authors

T. A Astrelina

Stem Cell Bank of the Moscow Department of Health, Mosow

A. E Gomzyakov

Stem Cell Bank of the Moscow Department of Health, Mosow

I. V Kobzeva

Stem Cell Bank of the Moscow Department of Health, Mosow

E. E Karpova

Stem Cell Bank of the Moscow Department of Health, Mosow

A. Y Kruglova

Stem Cell Bank of the Moscow Department of Health, Mosow

E. V Scorobogatova

D. Rogachev Federal Research Center of Pediatric Hematology, Oncology and Immunology, Moscow

D. N Balashov

Central Research Institute of Gastroenterology, Moscow

O. V Knyazev

Central Research Institute of Gastroenterology, Moscow

M. V Yakovleva

Stem Cell Bank of the Moscow Department of Health, Mosow

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