title: Gene therapy in vascular disease.
abstract: OBJECTIVE
  Peripheral artery disease is a highly prevalent disease which is characterised by high unmet medical need particularly in the more advanced stages of disease. Options comprise the need for vessel regeneration using therapeutic angiogenic gene therapy as well as the prevention of restenosis post-angioplasty using local gene therapy. Both problems have been addressed by extensive research. Recent advances in the knowledge of the complex regulation of angiogenesis and arteriogenesis and ways to its induction offer hope for a novel strategy that is based on the generation of such new vessels. This strategy termed "therapeutic angiogenesis" is a concept based on the use of angiogenic factors or stem cells or their combination to promote neovascularisation for the treatment of ischaemic tissues. This manuscript summarises the development of therapeutic angiogenic strategies using gene therapy.
  
  
  METHODS
  Review of current publications of phase I, II and III clinical trials and websites.
  
  
  RESULTS
  Phase II trials performed so far are difficult to compare due to different genes, vectors and applications routes used and different endpoints evaluated. Recently, the largest phase III trial did not confirm efficacy of non-viral gene transfer using the gene for fibroblast growth factor 1 in critical limb ischaemia.
  
  
  CONCLUSIONS
  Cardiovascular gene therapy, particularly, therapeutic angiogenesis has been shown to be safe, however, did not prove consistently efficacious in randomised controlled trials.
authors: Department of Clinical and Interventional Angiology, ASKLEPIOS Klinik St. Georg, Lohmühlenstraße 5, 20099 Hamburg, Germany.
authors: Fazilat
authors: F
authors: Sedighiani
authors: Sigrid
authors: S
authors: Nikol
mesh_terms: D043925:Angiogenesis Inducing Agents / Q000627:therapeutic use; D018014:Gene Transfer Techniques; D015316:Genetic Therapy; D006801:Humans; D018919:Neovascularization, Physiologic / Q000502:physiology; D058729:Peripheral Arterial Disease / Q000628:therapy*
chemical_list: D043925:Angiogenesis Inducing Agents