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

Neuromuscul Disord. 2002 Oct:12 Suppl 1:S52-4. doi: 10.1016/s0960-8966(02)00099-8.

Abstract

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I

MeSH terms

  • Animals
  • Clinical Protocols
  • DNA / therapeutic use
  • Dystrophin / deficiency
  • Dystrophin / genetics*
  • Dystrophin / therapeutic use
  • Ethics, Medical*
  • France
  • Genetic Therapy / ethics*
  • Genetic Therapy / legislation & jurisprudence*
  • Genetic Therapy / methods
  • Humans
  • Mass Media / standards
  • Muscular Dystrophy, Duchenne / genetics
  • Muscular Dystrophy, Duchenne / therapy*
  • Plasmids / genetics*

Substances

  • Dystrophin
  • DNA