title: Peripheral blood-derived autologous stem cell therapy for the treatment of patients with late-stage peripheral artery disease-results of the short- and long-term follow-up.
abstract: OBJECTIVE
  Regeneration of the occluded peripheral arteries by autologous stem cell therapy is an emerging treatment modality for no-option patients with peripheral artery disease (PAD). The purpose of this study was to assess safety and efficacy of in vitro-expanded, peripheral blood-derived, autologous stem cells (VesCell) in no-option patients with PAD.
  
  
  METHODS
  A phase II, open-label, randomized clinical study was performed on 20 patients to investigate the safety and efficacy of VesCell therapy at 1 and 3 months of follow-up. The long-term (2 years) efficacy of the therapy was also evaluated.
  
  
  RESULTS
  No side effects of VesCell therapy were found. During the 3 month follow-up in the control group, one death occurred and six major amputations were performed; in the treated group, there were no deaths or major amputations. The difference of limb loss is significant between the two groups. At 2-year follow-up in the control group, two deaths and six major amputations occurred; in the treated group, there were three major amputations. At 3-month follow-up, the change in hemodynamic parameters showed a significant increase in the treated group over the control group; in the treated group, further improvement was detected at 2 years. As the result of the VesCell treatment, change in pain score, wound healing and walking ability test showed an improvement compared with the control group; at 2 years, incremental improvement was observed.
  
  
  CONCLUSIONS
  Peripheral blood-derived, in vitro-expanded autologous angiogenic precursor therapy appears to be a safe, promising and effective adjuvant therapy for PAD patients.
authors.affiliation: Semmelweis University Faculty of Medicine, Department of Cardiovascular Surgery, Budapest, Hungary. szabogvdr@gmail.com
authors.forename: Gábor Viktor
authors.initials: GV
authors.lastname: Szabó
authors.forename: Zsuzsa
authors.initials: Z
authors.lastname: Kövesd
authors.forename: Judit
authors.initials: J
authors.lastname: Cserepes
authors.forename: Judit
authors.initials: J
authors.lastname: Daróczy
authors.forename: Michael
authors.initials: M
authors.lastname: Belkin
authors.forename: György
authors.initials: G
authors.lastname: Acsády
mesh_terms: D000368:Aged; D018450:Disease Progression; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D048091:Guided Tissue Regeneration; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000401:mortality / Q000628:therapy*; D036102:Peripheral Blood Stem Cell Transplantation; D011183:Postoperative Complications; D020127:Recovery of Function; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing
keywords: angiogenic cell precursors; clinical trial; peripheral artery disease; regenerative medicine