Evaluating Autologous Stem Cell Therapy for Peripheral Artery Disease

VesCell was one of the first of the present generation of commercialized stem cell therapies in which a patient's own cells are taken, expanded, and then returned to the body. The company was notable for marketing in the US while setting up clinics elsewhere in the world to evade onerous FDA restrictions on stem cell therapies: medical tourism at its finest. These sorts of treatments are only now becoming available in the US thanks to the fact that over the past fifteen years a range of pioneers successfully developed commercial clinical applications beyond the reach of US regulators. Otherwise we'd still be waiting and FDA bureaucrats would still be forbidding commercialization of stem cell research, demanding ever more trials and data.

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. 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.

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.

Peripheral blood-derived, in vitro-expanded autologous angiogenic precursor therapy appears to be a safe, promising and effective adjuvant therapy for PAD patients.

Link: http://www.celltherapyjournal.org/article/S1465-3249(13)00549-5/abstract

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