Long-term outcomes of mesenchymal stem cell therapy in severe COVID-19 patients: 3-year follow-up of a randomized, double-blind, placebo-controlled trial

作者：Mengqi Yuan, Le Song, Ze-Rui Wang, Ziying Zhang, Ming Shi, Junli He, Qiong Mo, Ning Zheng, Weiqi Yao, Yu Zhang, Tengyun Dong, Yuanyuan Li, Chao Zhang, Jin‐Wen Song, Lei Huang, Zhe Xu, Xin Yuan, Junliang Fu, Cheng Zhen, Jianming Cai, Jinghui Dong, Jianzeng Zhang, Wei‐Fen Xie, Yonggang Li, Bo Zhang, Lei Shi, Fu‐Sheng Wang · 发表于：Stem Cell Research & Therapy · 年份：2025 · DOI：10.1186/s13287-025-04148-1 · 被引用次数：10 · 研究领域：Mesenchymal stem cell research、COVID-19 Clinical Research Studies、Long-Term Effects of COVID-19

BACKGROUND: The long-term effects and outcomes of human mesenchymal stem cell (MSC) therapy in patients with severe coronavirus disease 2019 (COVID-19) remain poorly understood. This study aimed to evaluate the extended safety and efficacy of MSC treatment in severe patients with COVID-19 who participated in our earlier randomized, double-blind, placebo-controlled clinical trial, with follow-up conducted over 3 years. METHODS: cells/dose, on days 0, 3, and 6) or a placebo, with both groups receiving the standard of care. At 36 months post-MSC therapy, patients were followed up to long-term safety and efficacy, particularly the effects of MSC therapy on persistent COVID-19 symptoms. Evaluated outcomes included lung imaging results, 6-min walking distance (6-MWD), pulmonary function test results, quality of life scores based on the Short Form-36 (SF-36) health survey, Long COVID symptoms, new-onset comorbidities, tumor marker levels, and rates of COVID-19 reinfection. RESULTS: Three years post-treatment, 46.94% (23/49) of patients in the MSC group and 34.48% (10/29) in the placebo group showed normal findings on computed tomography (CT) images (odds ratio [OR] = 1.68, 95% confidence interval [CI]: 0.65-4.34). The general health (GH) score from the SF-36 was higher in the MSC group (67.0) compared to the placebo group (50.0), with a difference of 12.86 (95% CI: 1.44-24.28). Both groups showed similar results for total lung severity scores (TSS), 6-MWD, pulmonary function tests, ...