alexa Phase Ib Open Clinical Trial to Assess the Safety of Autologous Mesenchymal Stem Cells for the Treatment of Nonrevascularizable Critical Lower Limb Ischemia
ISSN: 2157-7633

Journal of Stem Cell Research & Therapy
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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

Riera del Moral L1,2*, Salazar Álvarez A1, Stefanov Kiuri S1, Tong H3,4, Riera de Cubas L1, García-Olmo D2,5 and García-Arranz M2,6

1Department of Angiology and Vascular Surgery, La Paz University Hospital, Spain

2Department of Surgery, School of Medicine, Autonomous University of Madrid, Spain

3Department of Clinical Pharmacology, La Paz University Hospital, Spain

4Department of Ministry of Economy and Competitiveness, Platform for Clinical Research and Clinical Trial Units (SCReN), Spain

5Department of General and Digestive Surgery, Fundación Jiménez Díaz, Spain

6Laboratory of New Therapies, Fundación Instituto de Investigación Sanitaria Fundación Jiménez Díaz, Spain

*Corresponding Author:
Riera del Moral L
Department of Angiology and Vascular Surgery
La Paz University Hospital, IdiPAZ, Madrid, Spain
Tel: +34 914 97 51 00
E-mail: [email protected]

Received date: June 20, 2017; Accepted date: June 23, 2017; Published date: June 30, 2017

Citation: Riera ML, Salazar AA, Stefanov KS, Tong H, Riera CL, et al. (2017) Phase Ib Open Clinical Trial to Assess the Safety of Autologous Mesenchymal Stem Cells for the Treatment of Nonrevascularizable Critical Lower Limb Ischemia. J Stem Cell Res Ther 7:391. doi: 10.4172/2157-7633.1000391

Copyright: © 2017 Riera ML, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

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. AT-MSCs were diluted into a final volume of 25 mL of Ringer solution and injected as 25 aliquots of 1 mL into each injection site on the limb. Injection sites were selected below the knee at 25 different sites of the ischemic calf muscle along the tibial and peroneal arteries. Liposuction was done in the abdomen.

Results: A total of 7 patients underwent treatment for 21 months. Two patients showed no serious complications with the liposuction, only pain and mild infection. No serious cell implantation-related adverse event occurred during the follow-up, although 2 patients had to undergo amputation. The ankle-brachial index and clinical assessment of the limb improved during the follow-up.

Conclusion: In conclusion, AT-MSC treatment of critical limb ischemia is feasible, safe and has promising initial results for salvaging limbs in the short term.

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