MedicalResearch.com Interview with:
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Critical limb ischemia (CLI) is the most severe form of peripheral arterial disease whereby a severe obstruction of the arteries markedly reduces blood flow to the extremities (hands, feet and legs) causing severe pain, skin ulcers, sores, or gangrene. Up to 30% of patients with CLI do not qualify for conventional interventions, such as a bypass or angioplasty, putting them at risk for amputation.
The MOBILE trial (MarrOwStim™ PAD Kit for the Treatment of Critical LimB IschemIa in Subjects with Severe Peripheral ArteriaL DiseasE) was designed to assess the safety and efficacy of using autologous concentrated bone marrow aspirate (cBMA), cells derived from the patient’s own bone marrow, to restore blood flow and prevent amputations in patients with CLI.
MOBILE is a Phase 3, double-blind, randomized, placebo-controlled trial that evaluated 152 patients with CLI at 24 centers in the U.S. Patients were randomized to receive cBMA or placebo via injection at 40 sites on the symptomatic leg. The cBMA was obtained from each patient using the MarrowStim PAD kit. The placebo group underwent a sham bone marrow aspiration and received needle punctures in the index leg.
The primary efficacy endpoint was amputation-free survival, defined as freedom from all causes of death and/or major amputation, at 52 weeks after treatment. Other endpoints included changes in blood flow in the leg, wound healing, measures of pain and quality of life, and distance walked in 6 minutes. The trial completed in June 2016, and a preliminary analysis found that cBMA demonstrated a meaningful improvement in amputation-free survival and a comparable safety profile to placebo.
MedicalResearch.com: What should readers take away from your report?
Response: Autologous bone marrow cell therapy may be a promising, non-invasive treatment option for patients with CLI at risk for amputation.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response:The MOBILE trial lays the groundwork for establishing the potential clinical value of autologous bone marrow cell therapy in patients with CLI.
Follow-up studies should focus on evaluating safety and efficacy in specific patient populations within CLI, such as people with diabetes or tissue loss, who are considered high risk for amputation. In addition, I hope to see future research delve into understanding the mechanism by which bone marrow cell therapy may improve blood flow and tissue perfusion.
MedicalResearch.com: Is there anything else you would like to add?
Response: I’m encouraged by the initial results of the MOBILE trial and look forward to publishing the final data analysis in the coming year. I hope our research is a starting point to encourage further exploration into the role of cell therapy in managing vascular disease.
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MOBILE CLINICAL TRIAL: MARROWSTIM PAD KIT FOR THE TREATMENT OF CRITICAL LIMB ISCHEMIA IN SUBJECTS WITH SEVERE PERIPHERAL ARTERIAL DISEASE
Presenter: Michael P. Murphy, MD
The phase 3 MOBILE clinical trial is a prospective, double-blind, placebo-controlled, randomized, multicenter study that sought to determine if autologous bone marrow–derived progenitor cells could decrease major amputation in patients with critical limb ischemia. It enrolled 152 patients at 24 sites. The rationale and design of this trial was based on a previous phase 1 trial and used a 3 (treatment) to 1 (placebo) ran¬domization scheme; stratification of randomization was also based on Rutherford score and presence of diabetes. This is the first phase 3 trial in the United States in cell therapy.
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