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Autologous peripheral blood-derived stem cells transplantation for treatment of no-option angiitis-induced critical limb ischemia: 10-year management experience
Stem Cell Research & Therapy ( IF 7.5 ) Pub Date : 2020-10-28 , DOI: 10.1186/s13287-020-01981-4
Gang Fang 1 , Xiaolang Jiang 1 , Yuan Fang 1 , Tianyue Pan 1 , Hao Liu 1 , Bichen Ren 1 , Zheng Wei 2 , Shiyang Gu 2 , Bin Chen 1 , Junhao Jiang 1 , Yun Shi 1 , Daqiao Guo 1 , Peng Liu 2 , Weiguo Fu 1, 3 , Zhihui Dong 1, 3
Affiliation  

Previous studies have demonstrated that no-option angiitis-induced critical limb ischemia (NO-AICLI) could be significantly improved by transplantation of peripheral blood-derived stem cells (PBDSCs). Additionally, a randomized controlled trial (RCT) recently conducted by us suggested that peripheral blood-derived purified CD34+ cells (PCCs) were not inferior to non-purified peripheral blood mononuclear cells (PBMNCs) at limb salvage in treatment of NO-AICLI. However, most of these clinical trials whether RCT or single-arm studies were characterized with a small sample size and absence of long-term outcomes. To analyze long-term clinical outcomes of PBDSCs transplantation for NO-AICLI, we reviewed clinical data of patients with NO-AICLI receiving PBDSCs transplantation at our center during the past decade. Meanwhile, we first compared the long-term safety and efficacy of intramuscular transplantation of PCCs versus PBMNCs in a sizable number of patients with NO-AICLI. From May 2009 to December 2019, a total of 160 patients with NO-AICLI patients were treated by PBDSCs transplantation (82 with PCCs, 78 with PBMNCs) at our center. Baseline characteristics between two groups were similar. Up to June 2020, the mean follow-up period was 46.6 ± 35.3 months. No critical adverse events were observed in either group. There was one death during the follow-up period. A total of eight major amputations occurred. The cumulative major amputation-free survival (MAFS) rate at 5 years after PBDSCs transplantation was 94.4%, without difference between two groups (P = .855). Wound healing, rest pain, pain-free walking time, ankle-brachial index, transcutaneous oxygen pressure, and quality of life (QoL) also significantly improved after PBDSCs transplantation. Autologous PBDSCs intramuscular transplantation could significantly decrease the major amputation rates and improve the QoL in patients with NO-AICLI. Long-term observation of a large sample of patients confirmed that the clinical benefits of PBDSCs transplantation were durable, without difference between the PCCs and PBMNCs groups.

中文翻译:

自体外周血源性干细胞移植治疗无选择性血管炎引起的严重肢体缺血:10年管理经验

先前的研究表明,通过移植外周血源性干细胞(PBDSC)可以显着改善无选择性血管炎引起的重症肢体缺血(NO-AICLI)。此外,我们最近进行的一项随机对照试验(RCT)表明,在NO-AICLI的治疗中,外周血来源的纯化CD34 +细胞(PCC)不劣于未纯化外周血单个核细胞(PBMNC)。但是,无论是RCT还是单臂研究,这些临床试验大多数都具有样本量小且没有长期结果的特点。为分析NO-AICLI的PBDSCs移植的长期临床结局,我们回顾了过去十年来我中心接受PBDSCs移植的NO-AICLI患者的临床数据。与此同时,我们首先在相当数量的NO-AICLI患者中比较了PCC与PBMNC的肌肉内移植的长期安全性和有效性。从2009年5月至2019年12月,我们中心共对160例NO-AICLI患者进行了PBDSC移植治疗(82例PCC,78例PBMNCs)。两组之间的基线特征相似。截至2020年6月,平均随访期为46.6±35.3个月。两组均未观察到严重不良事件。在随访期间有1人死亡。总共发生了8次大截肢。PBDSCs移植后5年的累积无大截肢生存率(MAFS)为94.4%,两组之间无差异(P = .855)。伤口愈合,休息疼痛,无痛行走时间,踝臂指数,经皮氧压,PBDSCs移植后,生活质量(QoL)也显着改善。自体PBDSCs肌肉内移植可显着降低NO-AICLI患者的主要截肢率并改善QoL。对大量患者的长期观察证实,PBDSCs移植的临床益处是持久的,而PCCs和PBMNCs组之间没有差异。
更新日期:2020-10-30
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