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

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.

Author information

1
Semmelweis University Faculty of Medicine, Department of Cardiovascular Surgery, Budapest, Hungary. szabogvdr@gmail.com

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

PMID:
23993298
DOI:
10.1016/j.jcyt.2013.05.017
[Indexed for MEDLINE]

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