title: How to design a cell or gene therapy clinical trial: advice from the FDA.
authors.forename: Adrian P
authors.initials: AP
authors.lastname: Gee
mesh_terms: D064987:Cell- and Tissue-Based Therapy; D002985:Clinical Protocols; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D015316:Genetic Therapy; D006801:Humans; D017410:Practice Guidelines as Topic; D014481:United States; D014486:United States Food and Drug Administration