Intraarterial Administration of Bone Marrow Mononuclear Cells in Patients With Critical Limb Ischemia

Critical limb ischemia due to peripheral arterial occlusive disease is associated with a severely increased morbidity and mortality. There is no effective pharmacological therapy available. Injection of autologous bone marrow-derived mononuclear cells (BM-MNC) is a promising therapeutic option in patients with critical limb ischemia, but double-blind, randomized trials are lacking. A Randomized-Start, Placebo-Controlled Pilot Trial (PROVASA) was published in Circulation - cardiovascular interventions.In this study Limb salvage and amputation-free survival rates did not differ between the control and study groups. However, cell therapy was associated with significantly improved ulcer healing (ulcer area, 3.2±4.7 cm² to 1.89±3.5 cm²P=0.014] versus placebo, 2.92±3.5 cm²² [P=0.5]) and reduced rest pain (5.2±1.8 to 2.2±1.3 [P=0.009] versus placebo, 4.5±2.4 to 3.9±2.6 [P=0.3]) within 3 months. 

We in India, need to be careful in jumping to conclusions without adequate  supportive evidence in favor of the cell therapies to treat the critical limb ischaemia for the present. If the strong evidence becomes available certainly and eagerly we are waiting to bring that in to our clinical practice.