Cell reports. Medicine · 2024
Autologous transplantation of P63+ lung progenitor cells in patients with bronchiectasis: A randomized, single-blind, controlled trial.
СтатьяРандомизированное исследованиеКлиническое исследование II фазыКлиническое исследование I фазыПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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Yan Jiayang, Zhang Weipan, Feng Yun, Liu Xuefei, Niu Lingyun, Guo Yi, Zhou Ling, Shi Mengmeng, Di Caixia, Zhang Qiurui, Wang Xiaofei, Zhou Jianping, Dai Ranran, Ni Lei, Bao Zhiyao, Yan Tianli, Hu Yun, Wang Ping, Zhang Ting, Zhou Min, Zuo Wei, Qu Jieming
Аннотация
Non-cystic fibrosis bronchiectasis is a progressive respiratory disease with limited treatment options, prompting the exploration of regenerative therapies. This study investigates the safety and efficacy of autologous P63+ progenitor cell transplantation in a randomized, single-blind, controlled, phase 1/2 trial. Thirty-seven patients receive bronchoscopic airway clearance (B-ACT) (n = 19) or B-ACT plus P63+ progenitor cells (n = 18). Results show that compared to the control group, the change in DLCO levels from baseline to 24 weeks post therapy is significantly higher in the cell treatment group (p value = 0.039). Furthermore, the patients in the cell treatment group demonstrate significantly reduced lung damaged area, improved SGRQ score, and ameliorated BSI and FACED scores within 4-12 weeks post therapy. Transcriptomic analysis reveals that progenitor cells with higher expression of P63 gene have better therapeutic efficacy. These findings suggest that P63+ progenitor cells may offer a promising therapeutic approach for bronchiectasis. This study was registered at ClinicalTrials.gov(NCT03655808).