Abstract

Our goal was to evaluate early results of the clinical application of autologous whole bone marrow stem cell transplantation (AWBMSCT) for critical limb ischemia (CLI) in patients with Buerger’s disease. We retrospectively analyzed the data of 58 limbs of 37 patients (mean age, 43.0 years; range, 28–63 years; male, 91.9%) with Buerger’s disease with CLI who were treated with AWBMSCT from March 2013 to December 2014. We analyzed Rutherford category, pain score, pain-free walking time (PFWT), total walking time (TWT), ankle brachial pressure index (ABPI), and toe brachial pressure index (TBPI), and investigated wound healing and occurrence of unplanned amputations. The mean follow-up duration was 11.9 ± 7.2 months (range, 0.9–23.9 months) and 100%, 72.4%, and 74.1% of patients were available to follow-up 1, 3 and 6 months after AWBMST, respectively. At 6 months, patients demonstrated significant improvements in Rutherford category (P < 0.0001), pain score (P < 0.0001), PFWT (P < 0.0001) and TBPI (P < 0.0001). ABPI was increased compared to baseline, but the difference was not significant. A total of 76.5% ischemic wounds achieved complete or improved healing. AWBMSCT is a safe and effective alternative or adjunctive treatment modality to achieve clinical improvement in patients with CLI.

Highlights

  • The prognosis of patients with critical limb ischemia (CLI), which represents ischemic rest pain and/or skin ulceration/gangrene[1], is quite poor in terms of both survival and limb salvage despite conventional therapeutic options such as medications, surgical treatments and endovascular interventions[2]

  • From March 2013 to December 2014, of 58 limbs of 37 patients with critical limb ischemia were treated with autologous whole bone marrow stem cell transplantation (AWBMSCT)

  • The proportion of the patients in the Rutherford category of 0–3 (CLI – free ratio) serially increased (Fig. 1B). These results suggest that AWBMSCT achieved clinical improvement and may lead to significant retrieval from CLI

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Summary

Introduction

The prognosis of patients with critical limb ischemia (CLI), which represents ischemic rest pain and/or skin ulceration/gangrene[1], is quite poor in terms of both survival and limb salvage despite conventional therapeutic options such as medications, surgical treatments and endovascular interventions[2]. A number of medical treatments for CLI have been studied, but none has obtained universal acceptance except for smoking cessation[4]. New treatment strategies for revascularization have been developed and the use of therapeutic angiogenesis using stem cell transplantation has been studied to treat patients for whom surgical or radiologic intervention is neither successful nor indicated. Studies of bone marrow aspirate injection for CLI showed that bone marrow cell therapy is a potential option in CLI patients who are not candidates for bypass or endovascular intervention[8]

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