Abstract
Critical limb ischemia (CLI) is associated with a high risk of limb amputation. It has been shown that cell therapy is safe and has beneficial effects on ischemic clinical symptoms in patients with CLI. The aim of this study was to further investigate the outcomes of intramuscular injection of autologous bone-marrow mononuclear cells (BM-MNCs) in a long-term follow-up period in atherosclerotic peripheral arterial disease (PAD) patients who have no optional therapy. This study was a retrospective and observational study that was carried out to evaluate long-term clinical outcomes in 42 lower limbs of 30 patients with atherosclerotic PAD who underwent BM-MNC implantation. The median follow-up period was 9.25 (range, 6–16) years. The overall amputation-free rates were 73.0% at 5 years after BM-MNC implantation and 70.4% at 10 years in patients with atherosclerotic PAD. The overall amputation-free rates at 5 years and at 10 years after implantation of BM-MNCs were significantly higher in atherosclerotic PAD patients than in internal controls and historical controls. There were no significant differences in amputation rates between the internal control group and historical control group. The rate of overall survival was not significantly different between the BM-MNC implantation group and the historical control group. Implantation of autologous BM-MNCs is feasible for a long-term follow-up period in patients with CLI who have no optional therapy.
Highlights
Guidelines for identifying severity and for appropriate treatments have been updated throughout the years
Kaplan-Meier analysis showed that the major amputation-free survival rate was higher in atherosclerotic peripheral arterial disease (PAD) patients who underwent bone-marrow mononuclear cells (BM-MNCs) implantation than in the internal controls and historical controls without cell therapy (Fig. 1)
The overall major amputation-free rates at 5 years and at 10 years were significantly higher in atherosclerotic PAD patients with BM-MNC implantation than in internal controls and historical controls
Summary
Guidelines for identifying severity and for appropriate treatments have been updated throughout the years. Patients who are diagnosed with CLI are at risk of major amputation if they do not receive specific treatment. The use of cell therapy in patients with CLI has been investigated for over 15 years. This therapeutic angiogenesis approach aims to offer a solution for no-option CLI patients. There has been scarce information on the long-term outcomes for over 10 years in atherosclerotic patients with CLI who underwent implantation of bone-marrow mononuclear cells (BM-MNCs) in order to reduce the amputation rate and to improve overall survival. We evaluated the long-term effects of intramuscular injection of autologous BM-MNCs on clinical outcomes in atherosclerotic PAD patients who had no optional therapy
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