Current protocol of a research phase I clinical trial of full-length dystrophin plasmid DNA in Duchenne/Becker muscular dystrophies. Part III. Ethical considerations.
Ethical aspects on human gene therapy are briefly discussed, in relation to the protocol developed in Duchenne/Becker muscular dystrophy with a full-length dystrophin plasmid. Differences between somatic therapies--as considered in this study--and germline gene interventions are underlined. Regulatory aspects for France are summarized. Special emphasis is put on the necessary control of publicity in the lay media in such a clinical study.
Institut de Myologie, AFM, Bâtiment Babinski, Hôpital de la Salpêtrière, 75651 Paris Cedex 13, France. m.fardeau@myologie.chups.jussieu.fr
Michel
M
Fardeau
D000818:Animals; D002985:Clinical Protocols; D004247:DNA / Q000627:therapeutic use; D016189:Dystrophin / Q000172:deficiency / Q000235:genetics* / Q000627:therapeutic use; D004992:Ethics, Medical; D005602:France; D015316:Genetic Therapy / Q000941:ethics* / Q000331:legislation & jurisprudence* / Q000379:methods; D006801:Humans; D008402:Mass Media / Q000592:standards; D020388:Muscular Dystrophy, Duchenne / Q000235:genetics / Q000628:therapy*; D010957:Plasmids / Q000235:genetics*
D016189:Dystrophin; D004247:DNA