Open AccessThree‐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
Author(s) -
Liu Hao,
Pan Tianyue,
Fang Yuan,
Fang Gang,
Liu Yifan,
Jiang Xiaolang,
Chen Bin,
Wei Zheng,
Gu Shiyang,
Liu Peng,
Fu Weiguo,
Dong Zhihui
Publication year - 2021
Publication title -
stem cells translational medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.781
H-Index - 71
eISSN - 2157-6580
pISSN - 2157-6564
DOI - 10.1002/sctm.20-0033
Subject(s) - medicine , peripheral blood mononuclear cell , amputation , randomized controlled trial , cd34 , surgery , transplantation , critical limb ischemia , gastroenterology , vascular disease , arterial disease , stem cell , biology , in vitro , biochemistry , genetics
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.