Department of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.
Department of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.
EBioMedicine. 2018 Sep;35:46-57. doi: 10.1016/j.ebiom.2018.08.038. Epub 2018 Aug 29.
Peripheral blood mononuclear cells (PBMNCs) and purified CD34 cells (PCCs) are increasingly being used at treating no-option critical limb ischaemia (NO-CLI). We aimed to compare the efficacies and uncover the advantages associated with each treatment approach.
A randomised single-blinded non-inferiority trial (Number: NCT 02089828) was performed. NO-CLI patients were 1:1 randomised to the PBMNCs and PCCs groups, and compared in relation to safety and efficacy outcomes. The primary efficacy outcomes included major amputation and total amputation over 12 months. The major amputation-free survival (MAFS) and total amputation-free survival (TAFS) rates were calculated.
Fifty patients (25 per group, 47 with thromboangiitis obliterans and 3 with other angiitis) were enrolled, with a median follow-up period of 24.5 months (interquartile range: 17-34 months). One patient in the PCCs group was lost at 2 months and one major amputation occurred in the PBMNCs group at 3 months post-transplantation. The total amputation rates at 6 months post-transplantation were 28.0% in the PCCs group and 16.0% in the PBMNCs group (p = 0.343), and remained unchanged at 12 months. The groups did not differ regarding the MAFS and TAFS (Breslow-Wilcoxon test: p = 0.3014 and p = 0.3414). The PCCs group had a significantly higher probability of rest pain relief than the PBMNCs group (Breslow-Wilcoxon test: p = 0.0454).
PCCs was not inferior to PBMNCs at limb salvage in the treatment of angiitis-induced NO-CLI and appeared to induce earlier ischaemia relief. Each cell type had specific advantages. These outcomes require verification from longer-term trials involving larger numbers of patients. FUND: Training program for outstanding academic leaders of Shanghai health and family planning system (Hundred Talent Program，Grant No. 2018BR40); China National Natural Science Funds (Grant No. 30801122); The excellent core member training programme at Zhongshan Hospital, Fudan University, China (Grant No. 2015ZSYXGG02); and Zhongshan Funds for the Institute of Vascular Surgery, Fudan University, China.
This study is registered with ClinicalTrials.gov (NCT 02089828).
外周血单个核细胞（PBMNCs）和纯化的 CD34 细胞（PCCs）越来越多地用于治疗无选择关键肢体缺血（NO-CLI）。我们旨在比较两种治疗方法的疗效，并揭示其各自的优势。
进行了一项随机、单盲、非劣效性试验（编号：NCT 02089828）。NO-CLI 患者按照 1:1 比例随机分为 PBMNCs 组和 PCCs 组，比较两组在安全性和疗效方面的结果。主要疗效终点包括 12 个月内的主要截肢和总截肢。计算主要截肢无复发生存率（MAFS）和总截肢无复发生存率（TAFS）。
共纳入 50 例患者（每组 25 例，47 例血栓闭塞性脉管炎和 3 例其他脉管炎），中位随访时间为 24.5 个月（四分位距：17-34 个月）。PCCs 组有 1 例患者在 2 个月时失访，PBMNCs 组有 1 例患者在移植后 3 个月发生主要截肢。移植后 6 个月的总截肢率在 PCCs 组为 28.0%，在 PBMNCs 组为 16.0%（p=0.343），12 个月时保持不变。两组在 MAFS 和 TAFS 方面无差异（Breslow-Wilcoxon 检验：p=0.3014 和 p=0.3414）。与 PBMNCs 组相比，PCCs 组缓解静息痛的可能性显著更高（Breslow-Wilcoxon 检验：p=0.0454）。
在治疗由血管炎引起的 NO-CLI 时，PCCs 在肢体挽救方面并不逊于 PBMNCs，并且似乎更早地缓解了缺血。每种细胞类型都有其特定的优势。这些结果需要来自涉及更多患者的长期试验来验证。
上海卫生和计划生育系统优秀学术带头人培养计划（百人计划，资助号：2018BR40）；中国国家自然科学基金（资助号：30801122）；复旦大学中山医院优秀核心成员培训计划，中国（资助号：2015ZSYXGG02）；复旦大学中山血管外科学研究所中山基金，中国。
本研究在 ClinicalTrials.gov 注册（NCT 02089828）。
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