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Registration Number

0220U000494, 0117U000149 , R & D reports

Title

To develop the criteria for quality and safety of biomedicinal cell-based products/drugs from cultured multipotent mesenchymal stromal cells of different tissue origin

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Head

Novikova Svitlana Mykolaivna, Доктор медичних наук

Registration Date

18-02-2020

Organization

Institute of genetic and regenerative medicine Acad.Med.Sci. of Ukraine

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The study was aimed developing a method for large-scale extension of endometrial multipotent mesenchymal stromal cells with no use of xenogeneic growth supplements to create an autologous biomedicinal cell-based product; assessment of the possibility of enhancing their therapeutic potential by pretreatment with atorvastatin or by forming 3D spheroids. Cell types derived from human extra-embryonic tissues were also studied as part of the study aimed to explore their secretion, culturing and morphological and functional characteristics. The minimal criteria for safety and quality of biomedicinal product based on human cells are proposed: infectious screening of donor and cell culture; phenotype, according to the expanded cell types; expression of the marker genes by expanded cell types; parameters of the kinetics of cell culture growth; directed multilineage differentiation of cell culture; criteria for cell culture senescence.

Product Description

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Васильєв Р.Г.
Злацька А.В.
Злацький І.А.
Зубов Д.О.
Родніченко А.Є.

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2020-04-02