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.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Prevention, Vascular Medicine, Interventions and Vascular Medicine

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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