التفاصيل البيبلوغرافية
| العنوان: |
The peripheral blood mononuclear cells versus purified CD34+ cells transplantation in patients with angiitis-induced critical limb ischemia trial: 5-year outcomes and return to work analysis—a randomized single-blinded non-inferiority trial |
| المؤلفون: |
Liu, Hao, Pan, Tianyue, Liu, Yifan, Fang, Yuan, Fang, Gang, Jiang, Xiaolang, Chen, Bin, Wei, Zheng, Gu, Shiyang, Liu, Peng, Fu, Weiguo, Dong, Zhihui |
| المصدر: |
Stem Cell Research & Therapy; 3/21/2022, Vol. 13 Issue 1, p1-12, 12p |
| مصطلحات موضوعية: |
MONONUCLEAR leukocytes, CELL transplantation, BASILIXIMAB, ISCHEMIA |
| مستخلص: |
Backgrounds: Patients with AICLI constitute a considerable proportion of NO-CLI patients and cannot be treated with surgical or endovascular treatment. Although cell therapy has shown satisfactory results in treating AICLI, research comparing the efficacy of treatment with the 2 kinds of cell products is rare. The aim of this study was to report the 5-year outcomes of a randomized single-blinded noninferiority trial (Number: NCT 02089828) on peripheral blood mononuclear cells (PBMNCs) and purified CD34+ cells (PCCs) transplantation for treating angiitis-induced critical limb ischemia (AICLI). Methods: A randomized single-blinded non-inferiority trial (Number: NCT 02089828) was performed. Fifty patients were randomized 1:1 to the PBMNCs and PCCs groups. Efficacy outcomes, safety outcomes and patients' work conditions were analyzed. The primary efficacy outcomes included major amputation and total amputation over 60 months. Results: During the 60-month follow-up, 1 patient was lost to follow-up, 1 died, and 2 underwent major amputation. The major amputation-free survival rate (MAFS) was 92.0% (95% confidence interval [CI] 82.0%-100.0%) in the PBMNCs group and 91.7% (95% CI 81.3%-100.0%) in the PCCs group (P = 0.980). Compared with the PCCs group, the PBMNCs group had a significantly higher 5-year new lesion-free survival rate (100.0% vs. 83.3% [95% CI 69.7–99.7%], P = 0.039). All patients lost their ability to work before transplantation, and the 5-year cumulative return to work (RTW) rates were 88.0% in the PBMNCs group and 76.0% in the PCCs group (P = 0.085). Conclusion: The long-term follow-up outcomes of this trial not only demonstrated similar efficacy and safety for the 2 types of autoimplants but also showed a satisfactory cumulative RTW rate in AICLI patients who underwent cell transplantation. Trial registration: ClinicalTrials.gov, number NCT 02089828. Registered 14 March 2014, https://clinicaltrials.gov/ct2/show/record/NCT02089828Test. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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