Current protocol of a research phase I clinical trial of full-length dystrophin plasmid DNA in Duchenne/Becker muscular dystrophies. Part III. Ethical considerations.

摘要

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.