In our latest FDA feed, Shilpita Karmakar offers a comprehensive overview of the significance of stem cell therapy and their potential implications in regenerative medicine, along with an outline of FDA-approved regulatory guidelines. Currently, most of the FDA-approved stem cell therapies are based on hematopoietic progenitor cells, which are primarily used for bone marrow transplants in the treatment of hematological malignancies. The source of the stem cells is critical in determining the end fate of the cell. Among all, induced pluripotent stem cells (iPSCs) show the most versatile form of differentiation and can be genetically modified into different cell types. The iPSCs based therapies enter into clinical trial phases only after strict compliance with the IND and FDA approval. This article thus summarizes the gradual “rise” of stem cells owing to their self-renewal characteristics, thus increasing their application for therapeutic interventions.
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