Clinical InvestigationPeripheral Vascular DiseaseLong-term clinical outcome after intramuscular implantation of bone marrow mononuclear cells (Therapeutic Angiogenesis by Cell Transplantation [TACT] trial) in patients with chronic limb ischemia
Section snippets
Patients and procedures
The study protocol has been described in detail previously.2 In brief, patients with chronic limb ischemia (Fontaine stage III and IV, PAD n = 74 and TAO n = 41) were qualified for BM-MNCs implantation. These ischemic limbs were confirmed that they were not candidates for surgical or nonsurgical revascularization by the Eligibility Judgment Committee composed of vascular surgeons, cardiologists, and radiologists. The diagnosis of TAO was based on the criteria by Olin17 or Shionoya18 from the
Patient characteristics, primary end points, and safety issues
A total of 115 patients (PAD 74 limbs, TAO 41 limbs) from 11 different hospitals were included in this study. The clinical outcomes and adverse events were separately analyzed in PAD and TAO groups because the pathologic etiology of vascular occlusion (arteriosclerosis vs thromboembolic process) was distinct between these 2 diseases. In fact, Table I shows a great difference in the baseline clinical characteristics of patients. The average of age, risk factors, complications of ischemic heart
Discussions
Arterial occlusion may cause intermittent claudication and, in some cases, will lead to critical leg ischemia and/or limb loss. In such cases, interventional therapies such as bypass surgery or percutaneous transluminal angioplasty are performed, whereas these interventions show relatively high rates of reocclusion.19 Therefore, alternative, preferentially pharmacologic, strategies for symptomatic and functional improvement have been required. Cilostazol is the first substance shown to increase
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Ephrin-B2-expressing natural killer cells induce angiogenesis
2022, JVS-Vascular Science
S. Matoba, T. Tatsumi, T. Murohara, T. Imaizumi, Y. Katsuda, M. Ito, Y. Saito, S. Uemura, H. Suzuki, S. Fukumoto, Y. Yamamoto, and H Matsubara. contributed to the study design, enrollment, and clinical follow-up of patients, aspiration and intramuscular injection of bone marrow, and the writing of manuscript. Onodera R., Teramukai S., and Fukushima M. contributed to the study design and statistical analysis of data.
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Co-investigators are listed in Appendix A.