[Impact of regulations on translational research in cell and gene therapy: the American experience].
The increasing utilization of cell and gene therapy in the treatment of human diseases, particularly cancers, has led lawmakers to institute stringent rules to regulate this new area of medicine and optimally protect patients. Cell and gene therapy centers, often located within academic institutions, are becoming subject to rules previously applied only to pharmaceutical companies. Based on the US experience, we review here the regulations that currently regulate or are being proposed to cover cell and gene therapy centers. We describe the principles of good manufacturing practices, quality assurance and quality control and accreditation. Finally, we discuss the future of cell and gene therapy in the context of the increasingly rigorous regulatory environment implemented in the US.
Rousseau
Raphaël F
RF
Center for Cell and Gene Therapy, Baylor College of Medicine, 6621 Fannin, MC 3-3320, Houston, Texas 77030, USA. rfrousse@TexasChildrensHospital.org
Gee
Adrian P
AP
D035843:Biomedical Research / Q000592:standards; D017690:Cell Transplantation / Q000331:legislation & jurisprudence* / Q000592:standards; D015316:Genetic Therapy / Q000331:legislation & jurisprudence* / Q000592:standards; D006801:Humans; D011786:Quality Control; D013048:Specimen Handling / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration