García-Arranz M
Spain
Research Article
Phase Ib Open Clinical Trial to Assess the Safety of Autologous
Mesenchymal Stem Cells for the Treatment of Nonrevascularizable
Critical Lower Limb Ischemia
Author(s): Riera del Moral L, Salazar Álvarez A, Stefanov Kiuri S, Tong H, Riera de Cubas L, García-Olmo D and García-Arranz M
Riera del Moral L, Salazar Álvarez A, Stefanov Kiuri S, Tong H, Riera de Cubas L, García-Olmo D and García-Arranz M
Background: Critical limb ischemia is a highly disabling disease, characterized by chronic pain at rest, ulceration and tissue tropism attributable to arterial occlusion. Despite significant advances in recent years in treating this disease, there are patients who, for technical reasons or because of the benefit/risk balance, have no therapeutic options other than amputation of the affected limb.
Objective: This study’s objective was to assess the feasibility and safety of autologous Adipose Tissue-Derived Mesenchymal Stem Cell (AT-MSC) implantation in patients with lower limb ischemia who are not candidates for surgical or endovascular revascularization.
Methods: This is a pragmatic, phase Ib, open, one-arm clinical trial, with a 1-year follow-up after cell implantation. The dose was 1 × 106 AT-MSCs/kg.. View More»
DOI:
10.4172/2157-7633.1000391