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Powell, R.J., Comerota, A.J., Berceli, S.A., Guzman, R., Henry, D.T., Tzeng, E., Velazquez, O., Marston, W.A., Bartel, R.L., Longcore, A., Stern, T. and Watling, S. (2011) Interim results from the RESTORE-CLI, a randomized, double-blidn multicenter phase II trial comparing expanded autologus bone marrow-derived tissue repair cells and placebo in patients with critical limb ischemia. Journal of Vascular Surgery, 54, 1032-1041. doi:10.1016/j.jvs.2011.04.006

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• TITLE: Long-term effect of autologous progenitor cell therapy to induce neo angiogenesis in patients with critical limb ischemia transplantated via intramuscular vs combined intramuscular and distal retrograde intra venous

  AUTHORS: Luis Padilla, Juan Rodriguez-Trejo, Ignacio Escotto, Manuel López-Hernandez, Mauricio González, José De Diego, Neftaly Rodrgiuez, Jesús Tapia, Takeshi Landero, Carranza Pilar Hazel, Olguin Juarez Horacio, Mauricio Di Silvio, Paul Mondragon-Teran

  KEYWORDS: Neo-Angiogenesis; Cell therapy; Critical Limb Ischemia; Progenitor Cells; Blood Perfusion

  JOURNAL NAME: Stem Cell Discovery, Vol.2 No.4, October 30, 2012

  ABSTRACT: Critical limb ischemia is a medical condition that decreases blood flow and limb oxygen supply; this disease in its late stages of progression leads to only two possible options: either surgical bypass revascularization or limb amputation. We investigated a novel method using autologous transplantation of progenitor cells derived from mobilized peripheral blood bone marrow mononuclear cells to evaluate its long-term effect as a cell therapy to induce neo-angiogenesis and restore blood flow in the affected ischemic limbs. A total of 20 ischemic limbs from critical limb ischemia diagnosed patients, non candidates to surgical revascularization were transplanted with autologous progenitor cells by either intramuscular combined with intravenous (group A) or intramuscular (group B) procedure. Patients were monitored during 31 months. Treatment efficacy was evaluated according to the following parameters: ankle brachial index which increased at a range of 0.29-1.0 in group A and 0.40-0.90 in group B; pain-free walking distance which increased at a range of 50-600 m in group A and 50-300 m in group B; and blood perfusion (measured by Laser Doppler) which increased at a range of 48-299 in group A and 135-225 in group B. We achieved 90% treated ischemic limbs free of amputation in both transplanted groups. Results here described provide a safe, efficient and minimally invasive therapy with progenitor cells to induce angiogenesis and preserve limbs from amputation in CLI diagnosed patients.