The peripheral blood mononuclear cells versus purified CD34(+) cells transplantation in patients with angiitis-induced critical limb ischemia trial: 5-year outcomes and return to work analysis-a randomized single-blinded non-inferiority trial.
The peripheral blood mononuclear cells versus purified CD34(+) cells transplantation in patients with angiitis-induced critical limb ischemia trial: 5-year outcomes and return to work analysis-a randomized single-blinded non-inferiority trial.
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DOI：
10.1186/s13287-022-02804-4
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发表时间：
2022-03-21
影响因子：
7.5
通讯作者：
Dong Z
中科院分区：
文献类型：
--
作者：
Liu H;Pan T;Liu Y;Fang Y;Fang G;Jiang X;Chen B;Wei Z;Gu S;Liu P;Fu W;Dong Z
AICLI患者在NO-CLI患者中占相当大的比例，不能接受手术或血管内治疗。虽然细胞疗法在治疗AICLI方面显示出令人满意的结果，但比较两种细胞产品治疗效果的研究很少。本研究的目的是报告外周血单个核细胞（PBMNCs）和纯化CD 34+细胞（PCCs）移植治疗血管炎诱导的严重肢体缺血（AICLI）的随机单盲非劣效性试验（编号：NCT 02089828）的5年结局。进行了一项随机单盲非劣效性试验（编号：NCT 02089828）。将50例患者以1：1的比例随机分配至PBMNCs组和PCCs组。分析疗效结局、安全性结局和患者的工作条件。主要疗效结局包括60个月内的大截肢和全截肢。在60个月随访期间，1例患者失访，1例死亡，2例接受大截肢。PBMNCs组和PCCs组的无大截肢生存率（MAFS）分别为92.0%（95%置信区间[CI] 82.0%-100.0%）和91.7%（95% CI 81.3%-100.0%）（P = 0.980）。与PCCs组相比，PBMNCs组的5年无新发病灶生存率显著更高（100.0% vs. 83.3% [95%CI 69.7-99.7%]，P = 0.039）。所有患者在移植前均丧失劳动能力，PBMNCs组和PCCs组的5年累计恢复工作（RTW）率分别为88.0%和76.0%（P = 0.085）。该试验的长期随访结果不仅证明了两种类型自体植入物的有效性和安全性相似，而且还显示了接受细胞移植的AICLI患者的累积RTW率令人满意。试验注册：ClinicalTrials.gov，编号NCT 02089828。2014年3月14日注册，https://clinicaltrials.gov/ct2/show/record/NCT02089828。
Patients with AICLI constitute a considerable proportion of NO-CLI patients and cannot be treated with surgical or endovascular treatment. Although cell therapy has shown satisfactory results in treating AICLI, research comparing the efficacy of treatment with the 2 kinds of cell products is rare. The aim of this study was to report the 5-year outcomes of a randomized single-blinded noninferiority trial (Number: NCT 02089828) on peripheral blood mononuclear cells (PBMNCs) and purified CD34+ cells (PCCs) transplantation for treating angiitis-induced critical limb ischemia (AICLI). A randomized single-blinded non-inferiority trial (Number: NCT 02089828) was performed. Fifty patients were randomized 1:1 to the PBMNCs and PCCs groups. Efficacy outcomes, safety outcomes and patients’ work conditions were analyzed. The primary efficacy outcomes included major amputation and total amputation over 60 months. During the 60-month follow-up, 1 patient was lost to follow-up, 1 died, and 2 underwent major amputation. The major amputation-free survival rate (MAFS) was 92.0% (95% confidence interval [CI] 82.0%-100.0%) in the PBMNCs group and 91.7% (95% CI 81.3%-100.0%) in the PCCs group (P = 0.980). Compared with the PCCs group, the PBMNCs group had a significantly higher 5-year new lesion-free survival rate (100.0% vs. 83.3% [95% CI 69.7–99.7%], P = 0.039). All patients lost their ability to work before transplantation, and the 5-year cumulative return to work (RTW) rates were 88.0% in the PBMNCs group and 76.0% in the PCCs group (P = 0.085). The long-term follow-up outcomes of this trial not only demonstrated similar efficacy and safety for the 2 types of autoimplants but also showed a satisfactory cumulative RTW rate in AICLI patients who underwent cell transplantation. Trial registration: ClinicalTrials.gov, number NCT 02089828. Registered 14 March 2014, https://clinicaltrials.gov/ct2/show/record/NCT02089828.
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影响因子：
7.2
作者：
Fukuhara, S;Bito, S;Kurokawa, K
通讯作者：
Kurokawa, K
DOI：
10.1161/atvbaha.109.198895
发表时间：
2010-06-01
影响因子：
8.7
作者：
Kumar, Arun H. S.;Caplice, Noel M.
通讯作者：
Caplice, Noel M.
影响因子：
2.6
作者：
Kum, Steven;Tan, Yih Kai;Mutirangura, Pramook
通讯作者：
Mutirangura, Pramook
影响因子：
--
作者：
Shintani, Satoshi;Kusano, Kengo;Losordo, Douglas W
通讯作者：
Losordo, Douglas W
影响因子：
37.8
作者：
Yoon, YS;Park, JS;Losordo, DW
通讯作者：
Losordo, DW