Bone marrow derived stem cells in regenerative medicine as advanced therapy medicinal products.
作者： Moccetti T , Lo Cicero , Soncin S , Astori G , Soldati G
DOI:
关键词: Medicine 、 Cell based 、 Investigational New Drug 、 Stem cell 、 Good manufacturing practice 、 Regenerative medicine 、 Bioinformatics 、 Bone marrow 、 Clinical trial 、 Cell isolation
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 reinfusion procedure in many cardiovascular diseases. Many these early clinical trials were performed a period before entry into force US European regulation on As result, conflicting data been generated effectiveness those therapies certain conditions as acute myocardial infarction. more academic medical centers private companies move toward exploiting full potential medicinal products, needs arise development infrastructure necessary to support investigations. This review describes regulatory environment surrounding production based products give practical aspects isolation, characterization, following Good Manufacturing Practice, focusing activities associated with investigational new drug development.
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