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RE-01 is an autologous cell therapy consisting of ex vivo cultured peripheral blood mononuclear cells (PBMCs), developed by ReEir Co., Ltd. It is designed to induce therapeutic angiogenesis in patients with refractory, non-healing ischemic lower extremity ulcers, particularly those who are not candidates for surgical or endovascular revascularization. The therapy involves collecting a patient's own PBMCs, culturing them to enhance their regenerative and angiogenic properties, and then injecting them intralesionally into the affected area. RE-01 is currently being evaluated in Phase II clinical trials for conditions such as Buerger's disease and various collagen-vascular diseases, including systemic sclerosis and systemic lupus erythematosus.
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