Comparative Study between Intramuscular and Intra-Arterial Autologous Transplantation of Bone Marrow Derived Mononuclear Cells in Treatment of Non Reconstructable Critical Limb Ischemia

Abstract
Background: Critical limb ischemia is a limb threatening condition characterized by ischemic rest pain, non-healing wounds, or tissue gangrene related to the peripheral arterial occlusive disease. Treatment of non-reconstructable critical limb ischemia is a challenge despite advances in surgical and endovascular techniques.
Aim: The aim is to compare the efficacy and safety of intramuscular and intra-arterial autologous transplantation of bone marrow derived mononuclear cells in treatment of non-reconstructable critical limb ischemia.
Material and Methods: This study was conducted on forty-five patients with non-reconstructable critical limb ischemia stages III or IV (Fontaine's classification) with ABI below 0.5 and the arteriogram showed no distal run-off and no option for revascularization. All patients were subjected to the best medical treatment according to (TASC II) then randomized (closed envelop) into three equal groups (15 patients in each group). Group I, II: Subjected to intra-arterial and intra-muscular autologous transplantation of bone marrow derived cells respectively while Group III only subjected to the best medical treatment as a control group. The primary outcomes were amputation free-survival and absence of therapy related major complication while secondary outcomes were improvement of ischemic rest pain assessed by Visual Ana-logue Scale (VAS), improvement of ischemic tissue perfusion assessed by Ankle Brachial Index (ABI), improvement of pain free walking distance, improvement of ischemic wound healing, detection of new collaterals in the angiogram and presence of neo-angiogenesis in calf muscle tru-cut needle biopsy.
Results: There were no significant differences between both Group I, II as regards the primary outcomes (limb salvage rates were 81.8%, 72.7% respectively, without therapy related major complication or mortality) and secondary outcomes during the follow-up period. When compared with the control group there were significant differences in both primary (limb salvage rate was 27.7%) and secondary outcomes.
Conclusions: No difference between autologous trans-plantation of bone marrow derived mononuclear cells either by intra-arterial or intra-muscular administration. Both routes are simple, safe and effective.