Clinical Trials on Stem Cell & Gene Therapy

Clinical trials on gene therapy products are often varying from the clinical trials design for other types of pharmaceutical products. The differences in trial design are necessitated by the distinctive features of these products. The clinical trials also reflect previous clinical experience and evidence of medicine. Early experiences with products indicate that some Gene Therapy products may pose substantial risks to subjects due to effect at cellular and genetic level. The design of early-phase clinical trials of Gene therapy products often involves the following consideration of clinical safety issues, preclinical issues, and chemistry, manufacturing and controls (CMC) issues that are encountered.

 

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