Wei Gao1, Fang Wang, Guanjian Liu, Xingwu Ran. 1. Diabetic Foot Care Center, Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, PR China.
Abstract
OBJECTIVE: To evaluate the effectiveness and safety of autologous hemopoietic stem cell implantation for peripheral arterial disease (PAD). METHODS: Randomized controlled trials (RCTs) were identified from CBM (1978 to September 2010), CNKI (1979 to September 2010), MEDLINE (1950 to September 2010), Pubmed (1950 to September 2010), Embase (1970 to September 2010), and Cochrane library (issue 4, 2010). The papers of the RCTs of clinical therapeutic studies on PAD treated by autologous hemopoietic stem cell implantation were included and analyzed according to the criteria of the Cochrane handbook. RESULTS: Eight RCTs involving 280 patients and 322 extremities were included, with majority of trials of low methodological quality. Meta-analysis indicated that autologous hemopoietic stem cell transplantation had an increased ulcer cure rate [RD = 0.38, 95% CI = (0.25, 0.50)], a significant improvement in the ankle brachial index [MD = 0.11, 95% CI = (0.04, 0.18)], transcutaneous oxygen tension [MD = 7.33, 95% CI = (3.14, 11.51)], and pain-free walking distance [SMD = 1.35, 95% CI = (0.90, 1.79)], a significant reduction in rest pain scores [MD = 1.70, 95% CI= (2.15, 1.25)], and a significant benefit in terms of limb salvage [RD = 0.19, 95% CI = (-0.31, 0.07)]. Only 2 trials reported the side effects of autologous hemopoietic stem cell transplantation, such as limbs swelling and concentrations of serum creatine phosphokinase increasing, and the long-term safety was not reported. CONCLUSION: Based on the review, autologous hemopoietic stem cell transplantation may have positive effect on "no-option" patients with PAD. However, the evidence is not strong enough due to the general low methodological quality, so we can not draw a reliable conclusion about the effects of autologous stem cell transplantation for PAD at the moment. Further larger, randomized, double blind, placebo-controlled, and multicenter trials are needed.
OBJECTIVE: To evaluate the effectiveness and safety of autologous hemopoietic stem cell implantation for peripheral arterial disease (PAD). METHODS: Randomized controlled trials (RCTs) were identified from CBM (1978 to September 2010), CNKI (1979 to September 2010), MEDLINE (1950 to September 2010), Pubmed (1950 to September 2010), Embase (1970 to September 2010), and Cochrane library (issue 4, 2010). The papers of the RCTs of clinical therapeutic studies on PAD treated by autologous hemopoietic stem cell implantation were included and analyzed according to the criteria of the Cochrane handbook. RESULTS: Eight RCTs involving 280 patients and 322 extremities were included, with majority of trials of low methodological quality. Meta-analysis indicated that autologous hemopoietic stem cell transplantation had an increased ulcer cure rate [RD = 0.38, 95% CI = (0.25, 0.50)], a significant improvement in the ankle brachial index [MD = 0.11, 95% CI = (0.04, 0.18)], transcutaneous oxygen tension [MD = 7.33, 95% CI = (3.14, 11.51)], and pain-free walking distance [SMD = 1.35, 95% CI = (0.90, 1.79)], a significant reduction in rest pain scores [MD = 1.70, 95% CI= (2.15, 1.25)], and a significant benefit in terms of limb salvage [RD = 0.19, 95% CI = (-0.31, 0.07)]. Only 2 trials reported the side effects of autologous hemopoietic stem cell transplantation, such as limbs swelling and concentrations of serum creatine phosphokinase increasing, and the long-term safety was not reported. CONCLUSION: Based on the review, autologous hemopoietic stem cell transplantation may have positive effect on "no-option" patients with PAD. However, the evidence is not strong enough due to the general low methodological quality, so we can not draw a reliable conclusion about the effects of autologous stem cell transplantation for PAD at the moment. Further larger, randomized, double blind, placebo-controlled, and multicenter trials are needed.