Systems approach to the guarantee of quality of mesenchymal stem cells of bone marrow for the clinical use

I A Shachpazyan; I V Kobzeva; T A Astrelina; M V Yakovleva; E Y Osipova; E V Skorobogatova

doi:10.23868/gc121659

Genes & Cells ›› 2011, Vol. 6 ›› Issue (2) : 51 -54. DOI: 10.23868/gc121659

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Systems approach to the guarantee of quality of mesenchymal stem cells of bone marrow for the clinical use

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Abstract

Mesenchymal stromal/stem cells (MSCs) of bone marrow(BM) origin not only provide the supportive microenvironmentalniche for hematopoietic stem cells (HSCs) but are also capableof differentiating into various cell types of mesenchymalorigin, such as bone, fat, and cartilage. The role is knownfor bone marrow-derived MSCs in reducing the incidence andseverity of graft-versus host disease (GVHD) during allogeneictransplantation. Purpose: to estimate quality and biologicalsafety the MSC of bone marrow for the transplantation.Were analyzed data expansion MSC of 94 BM at the Stem CellBank of Moscow between 2007 and 2010 on the registeredmedical technologies. MSC were revealed in the native formor frozen in liquid nitrogen. Quality, MSC was evaluated withof the bacteriological and virusological control; determinedthe viability of cells with the trypan blue and 7AAD; markersthat specifically identifies MSCs: CD73+; CD 90+; CD105+;CD45-; CD34-; CD14; CD133-; CD19-; HLA DR- by flowcytometry. The biological safety (karyotype) was analyzed byG-banding technique; 15-30 metaphase cells for each culturewere analyzed. To analyze the level aneuploidy, fluorescent insitu hybridization (FISH) with chromosome enumeration probes(CEP) studies was performed. Are developed the documents,which regulate the stages of the work of expansion MSC ofBM. Were prepared 71 MSC of BM (157 doses) and wereused for allogeneic transplantation 23 to patients (70doses MSC) for the purpose of adherence HSC, reducingthe incidence and severity of GVHD. In the majority of thecases of transplantation MSC it was carried out at thedose of 2 ×106/kg. There were no acute reactions during thetransplantation MSC BM. Thus, the estimation of quality andsafety MSC of BM for allogeneic transplantation, included: aconducting of documentation on GMP to standards, inspectionof a quantity of cells for achievement of optimum dose,bacteriological and virusological control, confirmation themarkers that specifically identifies MSCs and the estimationof biological safety.

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I A Shachpazyan, I V Kobzeva, T A Astrelina, M V Yakovleva, E Y Osipova, E V Skorobogatova. Systems approach to the guarantee of quality of mesenchymal stem cells of bone marrow for the clinical use. Genes & Cells, 2011, 6(2): 51-54 DOI:10.23868/gc121659

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