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首页> 外文期刊>Circulation journal >Therapeutic Efficacy of Autologous Non-Mobilized Enriched Circulating Endothelial Progenitors in Patients With Critical Limb Ischemia　― The SCELTA Trial ―
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Therapeutic Efficacy of Autologous Non-Mobilized Enriched Circulating Endothelial Progenitors in Patients With Critical Limb Ischemia　― The SCELTA Trial ―

机译：自体非动员富集循环内皮祖细胞对严重肢体缺血患者的治疗效果SCELTA试验

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Background: The therapeutic efficacy of bone marrow mononuclear cells (BM-MNC) autotransplantation in critical limb ischemia (CLI) has been reported. Variable proportions of circulating monocytes express low levels of CD34 (CD14+CD34lowcells) and behave in vitro as endothelial progenitor cells (EPCs). The aim of the present randomized clinical trial was to compare the safety and therapeutic effects of enriched circulating EPCs (ECEPCs) with BM-MNC administration. Methods?and?Results: ECEPCs (obtained from non-mobilized peripheral blood by immunomagnetic selection of CD14+and CD34+cells) or BM-MNC were injected into the gastrocnemius of the affected limb in 23 and 17 patients, respectively. After a mean of 25.2±18.6-month follow-up, both groups showed significant and progressive improvement in muscle perfusion (primary endpoint), rest pain, consumption of analgesics, pain-free walking distance, wound healing, quality of life, ankle-brachial index, toe-brachial index, and transcutaneous PO2. In ECEPC-treated patients, there was a positive correlation between injected CD14+CD34lowcell counts and the increase in muscle perfusion. The safety profile was comparable between the ECEPC and BM-MNC treatment arms. In both groups, the number of deaths and major amputations was lower compared with eligible untreated patients and historical reference patients. Conclusions: This study supports previous trials showing the efficacy of BM-MNC autotransplantation in CLI patients and demonstrates comparable therapeutic efficacy between BM-MNC and EPEPCs.
机译：背景：自体骨髓单核细胞（BM-MNC）移植治疗严重肢体缺血（CLI）的疗效已有报道。可变比例的循环单核细胞表达低水平的CD34（CD14 + CD34 low 细胞）并在体外表现为内皮祖细胞（EPC）。本随机临床试验的目的是比较富集循环EPC（ECEPC）与BM-MNC给药的安全性和治疗效果。方法和结果：将ECEPCs（通过未动员的外周血通过免疫磁选择CD14 + 和CD34 + 细胞获得）或BM-MNC注入腓肠肌。患肢分别有23例和17例。在平均25.2±18.6个月的随访后，两组患者的肌肉灌注（主要终点），静息疼痛，镇痛药的消耗，无痛步行距离，伤口愈合，生活质量，踝关节疼痛，足踝和足踝明显改善。臂指数，趾臂指数和经皮PO 2 。在接受ECEPC治疗的患者中，注射的CD14 + CD34 low 细胞计数与肌肉灌注增加之间存在正相关。 ECEPC和BM-MNC治疗组之间的安全性相当。与合格的未经治疗的患者和历史参照患者相比，两组的死亡人数和大截肢次数均较低。结论：这项研究支持先前的试验，该试验显示了BM-MNC自体移植在CLI患者中的疗效，并证明了BM-MNC和EPEPC之间具有可比的治疗效果。

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