drugset / Trial / NCT00539266

Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia

NCT00539266

Phase 2/3 Unknown 108 enrolled Leiden University Medical Center
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The investigators propose confirm and extend the findings of open studies on the apparent efficacy of bone-marrow derived mononuclear cells for the induction of arteriogenesis in patients with severe claudication or critical leg ischemia and pay special attention to the influence of diabetic disease on the outcome of the study and to the possible pro-atherogenic/ pro-inflammatory effects of BM-MNC injections.

Timeline

Start
2007-10
Primary completion
2012-10
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bone Marrow Derived Mononuclear Cells Cell therapy 1e+09 cells Intramuscular
Comparator Bone Marrow Derived Mononuclear Cells Cell therapy 8e+09 cells Intramuscular