Bone marrow derived stem cells in regenerative medicine as Advanced Therapy Medicinal Products

American Journal of Translational Research

Giuseppe Astori¹ 

关键词: “;    Good Manufacturing Practice”;    “;    Acute Myocardial Infarction”;    “;    Peripheral Vascular Disease”;    “;    Stem Cells”;    “;    Advanced Therapy Medicinal Products”;    “;    Cell Factory”;   

DOI  :  

学科分类：医学（综合）

来源: e-Century Publishing Corporation

【 摘 要 】

Bone marrow derived stem cells administered after minimal manipulation represent an important cell source for cellbased therapies. Clinical trial results, have revealed both safety and efficacy of the cell reinfusion procedure in many cardiovascular diseases. Many of these early clinical trials were performed in a period before the entry into force of the US and European regulation on cellbased therapies. As a result, conflicting data have been generated on the effectiveness of those therapies in certain conditions as acute myocardial infarction. As more academic medical centers and private companies move toward exploiting the full potential of cellbased medicinal products, needs arise for the development of the infrastructure necessary to support these investigations. This review describes the regulatory environment surrounding the production of cell based medicinal products and give practical aspects for cell isolation, characterization, production following Good Manufacturing Practice, focusing on the activities associated with the investigational new drug development.

【 授权许可】

CC BY-NC