drugset / Trial / NCT04288102
Treatment With Human Umbilical Cord-derived Mesenchymal Stem Cells for Severe Corona Virus Disease 2019 (COVID-19)
Phase 2
Completed
100 enrolled
Beijing 302 Hospital
Huoshenshan Hospital · collabMaternal and Child Health Hospital of Hubei Province · collabThe General Hospital of Central Theater Command · collabVcanbio Cell and Gene Engineering Corp., Ltd. · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
COVID-19 caused clusters of severe respiratory illness and was associated with 2% mortality. No specific anti-viral treatment exists. The mainstay of clinical management is largely symptomatic treatment, with organ support in intensive care for seriously ill patients. Cellular therapy, using mesenchymal stem cells has been shown to reduce nonproductive inflammation and affect tissue regeneration and is being evaluated in patients with ARDS. This clinical trial is to inspect the safety and efficiency of mesenchymal stem cells (MSCs) therapy for severe COVID-19.
Timeline
- Start
- 2020-03-05
- Primary completion
- 2020-05-12
- Completion
- 2020-07-09
Publications
- Yuan MQ, Song L, Wang ZR, Zhang ZY, Shi M, He J, Mo Q, Zheng N, Yao WQ, Zhang Y, Dong T, Li Y, Zhang C, Song J, Huang L, Xu Z, Yuan X, Fu JL, Zhen C, Cai J, Dong J, Zhang J, Xie WF, Li Y, Zhang B, Shi L, Wang FS. 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. Stem Cell Res Ther. 2025 Feb 25;16(1):94. doi: 10.1186/s13287-025-04148-1.
- Li TT, Zhang B, Fang H, Shi M, Yao WQ, Li Y, Zhang C, Song J, Huang L, Xu Z, Yuan X, Fu JL, Zhen C, Zhang Y, Wang ZR, Zhang ZY, Yuan MQ, Dong T, Bai R, Zhao L, Cai J, Dong J, Zhang J, Xie WF, Li Y, Shi L, Wang FS. Human mesenchymal stem cell therapy in severe COVID-19 patients: 2-year follow-up results of a randomized, double-blind, placebo-controlled trial. EBioMedicine. 2023 Jun;92:104600. doi: 10.1016/j.ebiom.2023.104600. Epub 2023 May 5.
- Shi L, Yuan X, Yao W, Wang S, Zhang C, Zhang B, Song J, Huang L, Xu Z, Fu JL, Li Y, Xu R, Li TT, Dong J, Cai J, Li G, Xie Y, Shi M, Li Y, Zhang Y, Xie WF, Wang FS. Human mesenchymal stem cells treatment for severe COVID-19: 1-year follow-up results of a randomized, double-blind, placebo-controlled trial. EBioMedicine. 2022 Jan;75:103789. doi: 10.1016/j.ebiom.2021.103789. Epub 2021 Dec 25.
- Shi L, Huang H, Lu X, Yan X, Jiang X, Xu R, Wang S, Zhang C, Yuan X, Xu Z, Huang L, Fu JL, Li Y, Zhang Y, Yao WQ, Liu T, Song J, Sun L, Yang F, Zhang X, Zhang B, Shi M, Meng F, Song Y, Yu Y, Wen J, Li Q, Mao Q, Maeurer M, Zumla A, Yao C, Xie WF, Wang FS. Effect of human umbilical cord-derived mesenchymal stem cells on lung damage in severe COVID-19 patients: a randomized, double-blind, placebo-controlled phase 2 trial. Signal Transduct Target Ther. 2021 Feb 10;6(1):58. doi: 10.1038/s41392-021-00488-5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mesenchymal stem cells | Cell therapy | 4e+07 cells | Intravenous |