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.
Description:
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.
Study Design
- Randomized
- Parallel
- Blinded
- Placebo
- Stratified
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%
Inclusion criteria:
- Patients with critical limb ischemia (Rutherford 4, 5) and not eligible for revascularization
- Ankle-brachial index <0.6, toe-brachial index <0.4
Exclusion criteria:
- Glycated hemoglobin >10%
- New York Heart Association class IV heart failure symptoms
- Creatinine >2.5 or on dialysis
- Amputation in the last 30 days
Principal Findings:
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).
Secondary outcomes:
- 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)
Interpretation:
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.
References:
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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