دورية أكاديمية

Three-year outcomes of peripheral blood mononuclear cells vs purified CD34+ cells in the treatment of angiitis-induced no-option critical limb ischemia and a cost-effectiveness assessment: A randomized single-blinded noninferiority trial

التفاصيل البيبلوغرافية
العنوان: Three-year outcomes of peripheral blood mononuclear cells vs purified CD34+ cells in the treatment of angiitis-induced no-option critical limb ischemia and a cost-effectiveness assessment: A randomized single-blinded noninferiority trial
المؤلفون: Liu, Hao, Pan, Tianyue, Fang, Yuan, Fang, Gang, Liu, Yifan, Jiang, Xiaolang, Chen, Bin, Wei, Zheng, Gu, Shiyang, Liu, Peng, Fu, Weiguo, Dong, Zhihui
المساهمون: Zhongshan Funds for the Institute of Vascular Surgery, Fudan University, Fudan University “Star of Tomorrow” Famous Doctor Training Project, Shanghai Excellent Academic Leader, Excellent Core Member Training Program at Zhongshan Hospital, Fudan University, China, China National Natural Science, Training Program for Outstanding Academic Leaders of the Shanghai Health and Family Planning System, Program of Shanghai Academic Research Leader
المصدر: Stem Cells Translational Medicine ; volume 10, issue 5, page 647-659 ; ISSN 2157-6564 2157-6580
بيانات النشر: Oxford University Press (OUP)
سنة النشر: 2021
مصطلحات موضوعية: Cell Biology, Developmental Biology, General Medicine
الوصف: For patients with angiitis-induced critical limb ischemia (AICLI), cell transplantation, such as purified CD34+ cells (PCCs) and peripheral blood mononuclear cells (PBMNCs), is gradually being used as a promising treatment. This was the first randomized single-blinded noninferiority trial (number: NCT 02089828) specifically designed to evaluate the therapeutic efficacies of the transplantation of PCCs vs those of PBMNCs for the treatment of AICLI. We aimed to compare the mid-term safety and efficacy between the two groups and determine their respective advantages. From April 2014 to September 2019, 50 patients with AICLI were equally allocated to the two groups, except for 1 lost patient, 1 amputee, and 1 patient who died of heart disease. The other 47 patients completed the 36-month follow-up. The endpoints were as follows: major amputation-free survival and total amputation-free survival at 6 months, which were 96.0% and 84.0% in the PBMNCs group and 96.0% and 72.0% in the PCCs group, respectively. These rates remained stable at 12, 24, and 36 months. The PCCs group had a significant higher probability of rest pain relief than the PBMNCs group, whereas earlier significant improvements in the Rutherford classification were observed in the PBMNCs group. Accordingly, PCCs would be preferred for patients with significant pain, whereas PBMNCs may be a good option for patients with two or more critically ischemic limbs. Concerning cost-effectiveness, PCCs are not more cost-effective than PBMNCs. These outcomes require verification from long-term trials involving larger numbers of patients.
نوع الوثيقة: article in journal/newspaper
اللغة: English
DOI: 10.1002/sctm.20-0033
الإتاحة: https://doi.org/10.1002/sctm.20-0033Test
https://academic.oup.com/stcltm/article-pdf/10/5/647/42626959/stcltm_10_5_647.pdfTest
حقوق: http://creativecommons.org/licenses/by-nc-nd/4.0Test/ ; http://creativecommons.org/licenses/by-nc-nd/4.0Test/ ; http://doi.wiley.com/10.1002/tdm_license_1.1Test
رقم الانضمام: edsbas.64363A8D
قاعدة البيانات: BASE