Aim: Peripheral arterial disease (PAD), particularly critical limb ischemia (CLI), is a severe cause of amputation and mortality. More than 50% of diabetic patients with CLI die within four to five years. The development of novel stem cell therapies may bring new hope to these patients. We aimed to assess the efficacy of autologous bone marrow cell for treating CLI using a meta-analysis.
Methods: We searched the literature in PubMed, the Cochrane Central Registry of Controlled Trials, the Elsevier database and EBSCO for trials of autologous cell in patients with severe PAD published before October 30, 2013. We chose objective clinical endpoints to assess the efficacy of in the meta-analysis, including changes in the ankle-brachial index (ABI), transcutaneous oxygen tension (TcO2), pain scale (0-10 scale) and amputation-free survival (AFS).
Results: Thirty-one articles reporting clinical trials involving a total of 1,214 patients treated with bone marrow stem cell-based were collected for the meta-analysis, in which the randomized controlled trials (RCTs) and other trials (non-RCTs) were classified into two groups. Regarding the efficacy of stem cell , the ABI showed significant increases (P＜0.05) at 12 , 24 and 48 weeks after in the non-RCT and RCT groups, but not after four to eight weeks in the non-RCT group. The TcO2 values also increased in the RCT group at four to eight weeks after and 24 weeks after (P＜0.001) and in the non-RCT group at four to eight weeks after (P= 0.01), although no significant increases were observed in the RCT group at 12 weeks after or the non-RCT group at 24 weeks after . Meanwhile, pain was significantly reduced (P＜0.05) at four to eight weeks and 24 weeks after in both the non-RCT and RCT groups, but not at four to eight weeks or 12 weeks after in the RCT group. In addition, the long-term clinical trials demonstrated that the AFS rate improved after with bone marrow stem cells (one-year AFS, P＜0.00001; three-year AFS, P=0.0003).
Conclusions: The present results suggest that autologous bone marrow stem cells have an advantageous effect in PAD patients who are not eligible for revascularization.
