Department of Vascular Surgery of Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.
National Clinical Research Center for Interventional Medicine, Shanghai, People's Republic of China.
Stem Cells Transl Med. 2022 May 27;11(5):504-512. doi: 10.1093/stcltm/szac017.
Although satisfying outcomes have been demonstrated in terms of autologous stem cell transplantation in the treatment of angiitis-induced critical limb ischemia (AICLI), few studies have systematically reported the recurrence conditions. In the current study, we aimed to investigate recurrence conditions of a relatively large AICLI cohort in our center during a long-term follow-up period. From May 2009 to August 2020, 181 patients with AICLI received peripheral blood mononuclear cells (PBMNCs) or purified CD34+ cells (PCCs) transplantation. The main outcomes included recurrence and new lesions. Patient demographic data, ischemic limb characteristics, interventional characteristics, etc., were identified and analyzed. A logistic multivariable regression was performed to identify the independent risk factors for recurrence by a stepwise selection of variables. One hundred forty-eight patients were enrolled in this study. The mean follow-up period was 62.3 ± 37.4 months (range 12-144 months). The 5- and 10-year recurrence-free rates were 88.5% (95% confidence interval [CI] 3.1%-82.6%) and 71.7% (95% CI 7.6%-58.2%), respectively. The 5- and 10-year new lesion-free rates were 93.2% (95% CI 2.2%-89.0%) and 91.7% (95% CI 2.7%-86.6%), respectively. The finding of multiple limbs involved (OR 1.322 95% CI 1.123-12.549, P = .036) and ischemia relief period ≥5 months (OR 3.367 95% CI 1.112-10.192, P = .032) were demonstrated to be independent risk factors for recurrence in patients with AICLI who underwent cell transplantation. For patients with AICLI who responded to cell transplantation, the durability of this therapy was satisfactory, with 5- and 10-year recurrence-free rates of 88.5% and 71.7%, respectively. Multiple limbs involved at admission and ischemia relief period ≥5 months were demonstrated to be independent risk factors for recurrence after transplantation.
尽管自体干细胞移植治疗血管炎相关性肢体缺血性坏疽（AICLI）已取得满意的结果，但很少有研究系统地报告其复发情况。在本研究中，我们旨在通过长期随访，探讨中心内较大 AICLI 队列的复发情况。2009 年 5 月至 2020 年 8 月，181 例 AICLI 患者接受外周血单个核细胞（PBMNCs）或纯化 CD34+细胞（PCCs）移植。主要结局包括复发和新病变。对患者的人口统计学数据、缺血肢体特征、介入特征等进行了识别和分析。采用逐步变量选择的方法，通过逻辑多变量回归分析，确定复发的独立危险因素。本研究共纳入 148 例患者。平均随访时间为 62.3±37.4 个月（范围 12-144 个月）。5 年和 10 年无复发生存率分别为 88.5%（95%可信区间[CI]：3.1%-82.6%）和 71.7%（95%CI：7.6%-58.2%）。5 年和 10 年无新发病变率分别为 93.2%（95%CI：2.2%-89.0%）和 91.7%（95%CI：2.7%-86.6%）。多肢受累（OR 1.322，95%CI：1.123-12.549，P=0.036）和缺血缓解期≥5 个月（OR 3.367，95%CI：1.112-10.192，P=0.032）是细胞移植后 AICLI 患者复发的独立危险因素。对于对细胞移植有反应的 AICLI 患者，这种治疗的耐久性令人满意，5 年和 10 年无复发生存率分别为 88.5%和 71.7%。移植后，多肢受累和缺血缓解期≥5 个月被证明是复发的独立危险因素。
