The new legal framework for minimally manipulated cells expands the possibilities for cell therapy in Russiaстатья
Статья опубликована в высокорейтинговом журнале
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Дата последнего поиска статьи во внешних источниках: 8 сентября 2021 г.
Аннотация:Cell-based therapy has been shown to be an effective option for the treatment of a wide range of pathologies. However, safety concerns related to the use of substantially manipulated cultured cells dictate the need for Good Manufacturing Practice facilities and extensive testing of cultured cell therapies, taking substantial time to obtain licensure and become available on the market. Therefore, an emerging concept of minimally manipulated cells centered on cell processing without substantial manipulation is an especially promising solution. Given a lower risk of unpredictable phenotype changes, minimally manipulated cells do not require pre-clinical and clinical trials and Good Manufacturing Practice facilities for processing, thus granting early access to a cell-based medicine.