title: Current gene therapy trials for vascular diseases.
abstract: BACKGROUND
  In the previous gene therapy trials for vascular diseases, safety of the therapies has been demonstrated with some evidence for clinical benefits. In the future, it will be important to also test the potential clinical benefits of the treatments in randomized and controlled trials with sufficient numbers of patients.
  
  
  METHODS
  This review covers 15 currently ongoing cardiovascular gene therapy trials that aim to treat coronary artery disease, heart failure and peripheral artery disease. This review summarizes current trials and their main features in the cardiovascular field.
  
  
  CONCLUSIONS
  In the gene therapy trials for vascular diseases, some limiting factors are still present. The trials have enrolled mainly elderly and severely affected patients who might not have the capacity to respond optimally to the therapies. Also, major cardiac adverse events, major amputations, mortality and other very demanding hard clinical end points have been used in relatively small patient populations. Therefore, there is an urgent need to enroll less severely affected patients and to use more informative surrogate end points in the forthcoming clinical trials.
authors.affiliation: University of Eastern Finland, A. I. Virtanen Institute, Department of Biotechnology and Molecular Medicine , P.O. Box 1627, FIN-70211, Kuopio , Finland +358 40 355 2076 ; seppo.ylaherttuala@uef.fi.
authors.forename: Paavo J
authors.initials: PJ
authors.lastname: Halonen
authors.forename: Jussi
authors.initials: J
authors.lastname: Nurro
authors.forename: Antti
authors.initials: A
authors.lastname: Kuivanen
authors.forename: Seppo
authors.initials: S
authors.lastname: Ylä-Herttuala
mesh_terms: D000818:Animals; D002318:Cardiovascular Diseases / Q000235:genetics* / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000379:methods; D003324:Coronary Artery Disease / Q000235:genetics / Q000628:therapy; D003327:Coronary Disease / Q000235:genetics / Q000628:therapy; D015316:Genetic Therapy / Q000379:methods*; D006333:Heart Failure / Q000235:genetics / Q000628:therapy; D006801:Humans