MarrowStim Treatment of Limb Ischemia in Subjects With Severe Peripheral Arterial Disease - MOBILE
Contribution To Literature:
The MOBILE pilot study demonstrated the safety of intramuscular injection of stem cells in critical limb ischemia.
The goal of the trial was to evaluate intramuscular injection of autologous bone marrow-derived stem cells compared with placebo injection among patients with critical limb ischemia.
Patients with critical limb ischemia were randomized to intramuscular injection of autologous bone marrow-derived stem cells (n = 119) versus placebo injection (n = 36).
- Total number of enrollees: 152
- Duration of follow-up: 12 months
- Median patient age: 65 years
- Percentage female: 42%
- Percentage with diabetes: 40%
- Patients with critical limb ischemia (Rutherford 4, 5) and not eligible for revascularization
- Ankle-brachial index <0.6, toe-brachial index <0.4
- Glycated hemoglobin >10%
- New York Heart Association class IV heart failure symptoms
- Creatinine >2.5 or on dialysis
- Amputation in the last 30 days
The primary safety outcome, incidence of serious adverse events, occurred in 59% of the stem cell group versus 69% of the placebo group (p = 0.33).
- Death or amputation: 20% of the stem cell group versus 31% of the placebo group (p = 0.22)
- Amputation: 16% of the stem cell group versus 22% of the placebo group (p = 0.39)
- Amputation (excluding Rutherford 5 diabetics): 9.6% of the stem cell group versus 27% of the placebo group (p = 0.021)
Among patients with critical limb ischemia, intramuscular injection of autologous bone marrow-derived stem cells was feasible. This small pilot study demonstrated the safety of intramuscular stem cell injection. Subgroup analysis revealed a possible signal for efficacy in Rutherford nondiabetics. Large studies are warranted to evaluate the clinical efficacy of this treatment approach.
Presented by Dr. Michael P. Murphy at the American Heart Association Annual Scientific Sessions (AHA 2016), New Orleans, LA, November 14, 2016.
Keywords: AHA Annual Scientific Sessions, Amputation, Ankle Brachial Index, Bone Marrow, Bone Marrow Cells, Cell- and Tissue-Based Therapy, Diabetes Mellitus, Injections, Intramuscular, Ischemia, Limb Salvage, Peripheral Arterial Disease, Primary Prevention, Stem Cells, Vascular Diseases
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