Methods We conducted a meta-analysis using data from randomized controlled trials (RCTs) by comparing autologous BMCs therapy with controls in patients with critical limb ischemia, and the primary endpoint is the incidence of amputation. Pubmed, EBSCO and the Cochrane Central Register of Controlled Trials (to approximately
July 25, 2012) were searched.
Results Seven RCTs with 373 patients were enrolled in the
meta-analysis. Because serious disease was the main reason leading to amputation in one trial, six studies with 333 patients were finally included in the meta-analysis. Pooling
the data of the final six studies, we found that BMCs therapy significantly decreased the incidence of amputation in patients with CLI (odds ratio (
OR), 0.37; 95% confidence interval (
CI), 0.22 to 0.62;
P=0.0002), and the efficacy had not significantly declined within 6 months after BMCs were transplanted;
OR, 0.33; 95%
CI, 0.16 to 0.70;
P=0.004 within 6 months and
OR, 0.30; 95%
CI, 0.11 to 0.79;
P=0.01 within 3 months. The rate of AFS after BMCs therapy was significantly increased in patients with Rutherford class 5 CLI (
OR 3.28; 95%
CI, 1.12 to 9.65;
P=0.03), while there was no significant improvement in patients with Rutherford class 4 (
OR 0.35; 95%
CI, 0.05 to 2.33;
P=0.28) compared with controls. The BMCs therapy also improved ulcer healing (
OR, 5.83; 95%
CI, 2.37 to 14.29;
P=0.0001).