By a News Reporter-Staff News Editor at Clinical Trials Week -- Data detailed on Biomedicine and Biomedical Engineering have been presented. According to news reporting out of Paris, France, by NewsRx editors, research stated, "Restenosis is a limitation of endovascular interventions performed in the superficial femoral artery (SFA). Preclinical studies have demonstrated that the perivascular delivery of tissue-engineered allogeneic aortic endothelial cells (PVS-10200) reduced stenosis in porcine models of SFA revascularization."
Our news journalists obtained a quote from the research from the University of Paris, "The purpose of this study was to investigate the safety and feasibility of percutaneous PVS-10200 delivery after angioplasty and stenting in the SFA of patients with peripheral artery disease. In this phase I open-label trial, 21 patients (average lesion length of 10.10 +/- 2.36 cm and >= 70% stenosis) were treated with PVS-10200: 11 in a low-dose cohort (cohort A) and 10 in a high-dose cohort (cohort B). The primary objective was to demonstrate the safety (incidence of major adverse events) of PVS-10200 within 4 weeks after surgery. Secondary end points included assessments of resting ankle-brachial index (ABI) in the treated leg, Fontaine class, and time to target lesion revascularization (TLR). No patient had a major adverse event within 4 weeks. One patient required a limb amputation at 30 weeks. At 48 weeks, cohort A and cohort B patients maintained a 37% and 62% increase in ABI compared with baseline, respectively; 70% of cohort A and 78% of cohort B improved by >= 1 Fontaine classification stage, and the TLR rate was 39% for cohort A and 20% for cohort B. Percutaneous local delivery of PVS-10200 is a well-tolerated and novel therapeutic approach that may be a suitable treatment for patients after endovascular intervention of the SFA."
According to the news editors, the research concluded: "Larger randomized trials are needed to determine if PVS-10200 can improve ABI and reduce TLR rates."
For more information on this research see: Pilot safety study of perivascular injection of tissue-engineered allogeneic aortic endothelial cells in patients undergoing minimally invasive peripheral revascularization. Journal of Vascular Surgery, 2014;59(6):1597-1606. Journal of Vascular Surgery can be contacted at: Mosby-Elsevier, 360 Park Avenue South, New York, NY 10010-1710, USA. (Elsevier - www.elsevier.com; Journal of Vascular Surgery - www.elsevier.com/wps/product/cws_home/623152)
Our news journalists report that additional information may be obtained by contacting M.A. Sevestre, University of Paris, Georges Pompidou European Hosp, AP HP, Dept. of Vasc Surg, F-75015 Paris, France. Additional authors for this research include J. Larghero, Y. Castier, H.M. Nugent, S. Visonneau and J.M. Alsac (see also Biomedicine and Biomedical Engineering).
Keywords for this news article include: Tissue Engineering, Biomedicine and Biomedical Engineering, Paris, France, Europe, Stenosis, Angiology, Bioengineering, Endothelial Cells
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