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

Cytotherapy. 2013 Oct;15(10):1245-52. doi: 10.1016/j.jcyt.2013.05.017.

Abstract

Background aims: 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.

Keywords: angiogenic cell precursors; clinical trial; peripheral artery disease; regenerative medicine.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Disease Progression
  • Feasibility Studies
  • Female
  • Follow-Up Studies
  • Guided Tissue Regeneration
  • Hemodynamics
  • Humans
  • Male
  • Middle Aged
  • Peripheral Arterial Disease / mortality
  • Peripheral Arterial Disease / therapy*
  • Peripheral Blood Stem Cell Transplantation*
  • Postoperative Complications*
  • Recovery of Function
  • Survival Analysis
  • Time Factors*
  • Treatment Outcome
  • Wound Healing