Autologous peripheral blood-derived stem cells transplantation for treatment of no-option angiitis-induced critical limb ischemia: 10-year management experience.

Autologous peripheral blood-derived stem cells transplantation for treatment of no-option angiitis-induced critical limb ischemia: 10-year management experience.
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DOI:
10.1186/s13287-020-01981-4
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发表时间:
2020-10-28
影响因子:
7.5
通讯作者:
Dong Z
Dong Z
中科院分区:
医学2区
文献类型:
--
作者:
Fang G;Jiang X;Fang Y;Pan T;Liu H;Ren B;Wei Z;Gu S;Chen B;Jiang J;Shi Y;Guo D;Liu P;Fu W;Dong Z

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既往研究表明,外周血干细胞(PBDSCs)移植可显著改善非选择性血管炎引起的严重肢体缺血(NO-AICLI)。此外,我们最近进行的一项随机对照试验(RCT)表明,外周血来源的纯化CD 34+细胞(PCCs)在治疗NO-AICLI的保肢中不劣于非纯化外周血单核细胞(PBMNCs)。然而,这些临床试验中的大多数,无论是随机对照试验还是单组研究,都具有样本量小和缺乏长期结局的特点。为了分析PBDSCs移植治疗NO-AICLI的长期临床结果,我们回顾了过去十年在我们中心接受PBDSCs移植的NO-AICLI患者的临床数据。与此同时,我们首先在大量NO-AICLI患者中比较了PCC与PBMNCs肌内移植的长期安全性和有效性。从2009年5月至2019年12月,共有160例NO-AICLI患者在我中心接受了PBDSCs移植治疗(82例为PCCs,78例为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。随访期间有1例死亡。共发生8例大截肢。PBDSCs移植后5年的累积无大截肢存活率(MAFS)为94.4%,两组之间无差异(P = .855)。PBDSCs移植后,伤口愈合、静息痛、无痛行走时间、踝臂指数、经皮氧分压和生活质量(QoL)也显著改善。自体PBDSCs肌内移植可显著降低NO-AICLI患者的大截肢率,改善患者的生活质量。对大样本患者的长期观察证实,PBDSCs移植的临床益处是持久的,PCCs组和PBMNCs组之间没有差异。
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.
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