FEATURES OF DEVELOPMENT, PRECLINICAL, AND CLINICAL STUDIES OF BIOMEDICAL CELL PRODUCTS
Keywords:
Keywords: biomedical cell products, cell therapy, regenerative medicine, preclinical studies, clinical trials, cell sourcing, manufacturing, regulatory considerations.Abstract
Abstract: Biomedical cell products (BCPs) hold tremendous promise for revolutionizing medical treatments by harnessing the regenerative and therapeutic potential of cells. However, the development, preclinical evaluation, and clinical translation of BCPs present unique challenges and considerations compared to traditional pharmaceuticals. This review provides a comprehensive overview of the key features and stages involved in the development, preclinical testing, and clinical evaluation of BCPs. Topics covered include cell sourcing and characterization, manufacturing processes, preclinical safety and efficacy assessments, regulatory considerations, and clinical trial design. By understanding and addressing these critical aspects, researchers and regulatory agencies can facilitate the safe and effective translation of BCPs from the laboratory to clinical practice, thereby advancing the field of regenerative medicine and improving patient outcomes.
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