Autologous peripheral blood-derived stem cells transplantation for treatment of no-option angiitis-induced critical limb
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RESEARCH
Open Access
Autologous peripheral blood-derived stem cells transplantation for treatment of nooption angiitis-induced critical limb ischemia: 10-year management experience Gang Fang1†, Xiaolang Jiang1†, Yuan Fang1, Tianyue Pan1, Hao Liu1, Bichen Ren1, Zheng Wei2, Shiyang Gu2, Bin Chen1, Junhao Jiang1, Yun Shi1, Daqiao Guo1, Peng Liu2, Weiguo Fu1,3* and Zhihui Dong1,3*
Abstract Background: 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. Methods: 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. Results: 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. Conclusions: 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. Keywords: Stem cells transplantation, Critical limb ischemia, Thromboangiitis obliterans, Periphreal blood mononuclear cells, CD34+ cells, Limb salvage
* Correspondence: [email protected]; [email protected] † Gang Fang and Xiaolang Jiang contributed equally to this work. 1 Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attrib
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