Diabetes affects multiple systems in complex manners. Diabetic foot ulcers (DFUs) are a result of diabetes-induced microarterial vessel disease and peripheral neuropathy. The presence of arteriosclerosis-induced macroarterial disease can further complicate DFU pathophysiology. Recent studies suggest that mesenchymal stromal cell therapies can enhance tissue regeneration. This phase I study was designed to determine the safety and explore the efficacy of local injections of autologous adipose-derived stromal vascular fraction (SVF) cells to treat nonhealing DFUs greater than 3 cm in diameter. Sixty-three patients with type 2 diabetes with chronic DFU—all amputation candidates—were treated with 30 × 10⁶ SVF cells injected in the ulcer bed and periphery and along the pedal arteries. Patients were seen at 6 and 12 months to evaluate ulcer closure. Doppler ultrasounds were performed in a subset of subjects to determine vascular structural parameters. No intervention-related serious adverse events were reported. At 6 months, 51 subjects had 100% DFU closure, and 8 subjects had ≥75% closure. Three subjects had early amputations, and one subject died. At 12 months, 50 subjects had 100% DFU healing and 4 subjects had ≥85% healing. Five subjects died between the 6- and 12-month follow-up visits. No deaths were intervention related. Doppler studies in 11 subjects revealed increases in peak systolic velocity and pulsatility index in 33 of 33 arteries, consistent with enhanced distal arterial runoff. These results indicate that SVF can be safely used to treat chronic DFU, with evidence of efficacy (wound healing) and mechanisms of action that include vascular repair and/or angiogenesis.

中文翻译：

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脂肪源性基质血管部分细胞注射治疗慢性糖尿病足溃疡：安全性和 1 年疗效证据

糖尿病以复杂的方式影响多个系统。糖尿病足溃疡 (DFU) 是糖尿病引起的微动脉血管疾病和周围神经病变的结果。动脉硬化引起的大动脉疾病的存在会使 DFU 的病理生理学进一步复杂化。最近的研究表明，间充质基质细胞疗法可以增强组织再生。这项 I 期研究旨在确定安全性并探索局部注射自体脂肪来源的基质血管分数 (SVF) 细胞治疗直径大于 3 cm 的不愈合 DFU 的疗效。63 名患有慢性 DFU 的 2 型糖尿病患者（均为截肢候选者）接受了 30 × 10 ⁶SVF 细胞注入溃疡床和外周以及沿足动脉。在 6 个月和 12 个月时观察患者以评估溃疡闭合情况。在一组受试者中进行多普勒超声以确定血管结构参数。没有报告与干预相关的严重不良事件。在 6 个月时，51 名受试者的 DFU 闭合率为 100%，8 名受试者的闭合率≥75%。三名受试者早期截肢，一名受试者死亡。在 12 个月时，50 名受试者的 DFU 愈合率为 100%，4 名受试者的愈合率≥85%。5 名受试者在 6 个月和 12 个月的随访期间死亡。没有死亡与干预相关。对 11 名受试者的多普勒研究显示，33 支动脉中有 33 支动脉的峰值收缩速度和搏动指数增加，这与远端动脉径流增加一致。