S Keisin Wang1, Linden A Green1, Raghu L Motaganahalli1, Michael G Wilson2, Andres Fajardo1, Michael P Murphy3. 1. Division of Vascular Surgery, Indiana University School of Medicine, Indianapolis, Ind. 2. Division of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, Ind. 3. Division of Vascular Surgery, Indiana University School of Medicine, Indianapolis, Ind. Electronic address: mipmurph@iupui.edu.
Abstract
OBJECTIVE: Critical limb ischemia (CLI) continues to place a significant encumbrance on patients and the health care system as it progresses to limb loss and long-term disability. Traditional methods of revascularization offer a significant benefit; however, for one-third of CLI patients, these surgical options are not technically possible or patency is severely limited by disease burden (deemed "poor-option" for revascularization). In a previous phase I trial, we demonstrated intramuscular injection of concentrated bone marrow aspirate (cBMA) via MarrowStim (Zimmer Biomet, Warsaw, Ind) harvest is safe and may decrease major amputation in patients with CLI unfit for surgical revascularization. Therefore, we describe and rationalize the MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia in Subjects with Severe Peripheral Arterial Disease (MOBILE) trial, a study geared to provide the pivotal proof of efficacy of cBMA in CLI. METHODS: MOBILE is a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the efficacy of intramuscular injections of cBMA in promoting amputation-free survival in patients with poor-option CLI. Patients (aged >21 years) with rest pain or tissue loss resulting from advanced peripheral arterial disease, as characterized by ankle-brachial index (<0.6), toe-brachial index (<0.4), or transcutaneous pressure of oxygen (<50 mm Hg), were eligible for inclusion if surgical revascularization was not possible secondary to advanced disease. RESULTS: Treatment and 1-year follow-up of 152 patients enrolled in MOBILE are completed. Long-term follow-up is ongoing. Currently, we are in the process of unblinding the initial results for preliminary data analysis. CONCLUSIONS: If successful, MOBILE could add definitive, high-quality evidence in support of cBMA for the treatment of poor-option CLI patients and provide an additional modality for patients who face amputation secondary to advanced limb ischemia.
RCT Entities:
OBJECTIVE:Critical limb ischemia (CLI) continues to place a significant encumbrance on patients and the health care system as it progresses to limb loss and long-term disability. Traditional methods of revascularization offer a significant benefit; however, for one-third of CLI patients, these surgical options are not technically possible or patency is severely limited by disease burden (deemed "poor-option" for revascularization). In a previous phase I trial, we demonstrated intramuscular injection of concentrated bone marrow aspirate (cBMA) via MarrowStim (Zimmer Biomet, Warsaw, Ind) harvest is safe and may decrease major amputation in patients with CLI unfit for surgical revascularization. Therefore, we describe and rationalize the MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia in Subjects with Severe Peripheral Arterial Disease (MOBILE) trial, a study geared to provide the pivotal proof of efficacy of cBMA in CLI. METHODS: MOBILE is a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the efficacy of intramuscular injections of cBMA in promoting amputation-free survival in patients with poor-option CLI. Patients (aged >21 years) with rest pain or tissue loss resulting from advanced peripheral arterial disease, as characterized by ankle-brachial index (<0.6), toe-brachial index (<0.4), or transcutaneous pressure of oxygen (<50 mm Hg), were eligible for inclusion if surgical revascularization was not possible secondary to advanced disease. RESULTS: Treatment and 1-year follow-up of 152 patients enrolled in MOBILE are completed. Long-term follow-up is ongoing. Currently, we are in the process of unblinding the initial results for preliminary data analysis. CONCLUSIONS: If successful, MOBILE could add definitive, high-quality evidence in support of cBMA for the treatment of poor-option CLI patients and provide an additional modality for patients who face amputation secondary to advanced limb ischemia.
Authors: S Fadilah Abdul Wahid; Nor Azimah Ismail; Wan Fariza Wan Jamaludin; Nor Asiah Muhamad; Muhammad Khairul Azaham Abdul Hamid; Hanafiah Harunarashid; Nai Ming Lai Journal: Cochrane Database Syst Rev Date: 2018-08-29
Authors: S Keisin Wang; Linden A Green; Natalie A Drucker; Raghu L Motaganahalli; Andres Fajardo; Michael P Murphy Journal: J Vasc Surg Date: 2018-02-01 Impact factor: 4.268