A Multicenter Prospective Interventional Trial of Therapeutic Angiogenesis Using Bone Marrow-Derived Mononuclear Cell Implantation for Patients With Critical Limb-Threatening Ischemia Caused by Thromboangiitis Obliterans
Ayumu Fujioka, Kenji Yanishi, Arito Yukawa, Kojiro Imai, Isao Yokota, Kei Fujikawa, Ayumu Yamada, Akari Naito, Keisuke Shoji, Hirofumi Kawamata, Yukihito Higashi, Tomoaki Ishigami, Ken‐ichiro Sasaki, Syuhei Tara, Koichiro Kuwahara, Satoshi Teramukai, Satoaki Matoba
Abstract
BACKGROUND: Thromboangiitis obliterans (TAO) can lead to the development of critical limb-threatening ischemia (CLTI). Despite conventional treatments, such as smoking cessation or revascularization, young patients (<50 years) still require limb amputation. Therapeutic angiogenesis using bone marrow-derived mononuclear cell (BM-MNC) implantation has been tested and shown to have reasonable efficacy in CLTI. In this multicenter prospective clinical trial, we evaluated the safety and efficacy of BM-MNC implantation in CLTI patients with TAO. METHODS AND RESULTS: . Major amputation-free and overall survival probabilities at 3 years among all enrolled patients were high (95.5% and 89.5%, respectively). CONCLUSIONS: BM-MNC implantation showed safety and significant efficacy in CLTI patients with TAO.