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.

Abstract

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: NCT02089828) 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: NCT02089828) 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 NCT02089828. Registered 14 March 2014, https://clinicaltrials.gov/ct2/show/record/NCT02089828 .

• Authors: Hao Liu, Tianyue Pan, Yifan Liu, Yuan Fang, Gang Fang, Xiaolang Jiang, Bin Chen, Zheng Wei, Shiyang Gu, Peng Liu, Weiguo Fu, Zhihui Dong
• Journal: Stem cell research & therapy (Stem Cell Res Ther) Vol. 13 Issue 1 Pg. 116 (03 21 2022) ISSN: 1757-6512 [Electronic] England
• PMID: 35313967 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2022. The Author(s).

Topics

• Cell Transplantation
• Chronic Limb-Threatening Ischemia
• Humans
• Ischemia (therapy)
• Leukocytes, Mononuclear
• Return to Work
• Treatment Outcome
• Vasculitis