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Human mesenchymal stem cells treatment for severe COVID-19: 1-year follow-up results of a randomized, double-blind, placebo-controlled trial.
Shi, Lei; Yuan, Xin; Yao, Weiqi; Wang, Siyu; Zhang, Chao; Zhang, Bo; Song, Jinwen; Huang, Lei; Xu, Zhe; Fu, Jun-Liang; Li, Yuanyuan; Xu, Ruonan; Li, Tian-Tian; Dong, Jinghui; Cai, Jianming; Li, Genshi; Xie, Yunbo; Shi, Ming; Li, Yonggang; Zhang, Yu; Xie, Wei-Fen; Wang, Fu-Sheng.
  • Shi L; Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, No.100 Western 4th Ring Road, Beijing 100039, China; Wuhan Huoshenshan Hospital, Wuhan, China.
  • Yuan X; Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, No.100 Western 4th Ring Road, Beijing 100039, China; Wuhan Huoshenshan Hospital, Wuhan, China.
  • Yao W; Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; National Industrial Base for Stem Cell Engineering Products, Tianjin, China.
  • Wang S; Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, No.100 Western 4th Ring Road, Beijing 100039, China.
  • Zhang C; Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, No.100 Western 4th Ring Road, Beijing 100039, China; Wuhan Huoshenshan Hospital, Wuhan, China.
  • Zhang B; Department of Infectious Disease, General Hospital of Central Theater Command, Wuhan, China.
  • Song J; Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, No.100 Western 4th Ring Road, Beijing 100039, China; Wuhan Huoshenshan Hospital, Wuhan, China.
  • Huang L; Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, No.100 Western 4th Ring Road, Beijing 100039, China; Wuhan Huoshenshan Hospital, Wuhan, China.
  • Xu Z; Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, No.100 Western 4th Ring Road, Beijing 100039, China; Wuhan Huoshenshan Hospital, Wuhan, China.
  • Fu JL; Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, No.100 Western 4th Ring Road, Beijing 100039, China; Wuhan Huoshenshan Hospital, Wuhan, China.
  • Li Y; Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, No.100 Western 4th Ring Road, Beijing 100039, China.
  • Xu R; Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, No.100 Western 4th Ring Road, Beijing 100039, China.
  • Li TT; Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, No.100 Western 4th Ring Road, Beijing 100039, China; The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Scienc
  • Dong J; Department of Radiology, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.
  • Cai J; Department of Radiology, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.
  • Li G; Wuhan Kingmed Center for Clinical Laboratory Co., Ltd., Wuhan, China.
  • Xie Y; Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, No.100 Western 4th Ring Road, Beijing 100039, China.
  • Shi M; Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, No.100 Western 4th Ring Road, Beijing 100039, China.
  • Li Y; Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, No.100 Western 4th Ring Road, Beijing 100039, China.
  • Zhang Y; National Industrial Base for Stem Cell Engineering Products, Tianjin, China; VCANBIO Cell&Gene Engineering Corp., Ltd., Tianjin, China.
  • Xie WF; Department of Gastroenterology, Changzheng Hospital, Naval Medical University, 415 Fengyang Road, Shanghai, 200003, China; Optical Valley Branch of Maternal and Child Hospital of Hubei Province, Wuhan, China. Electronic address: weifenxie@medmail.com.cn.
  • Wang FS; Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, No.100 Western 4th Ring Road, Beijing 100039, China; Wuhan Huoshenshan Hospital, Wuhan, China. Electronic address: fswang302@163.com.
EBioMedicine ; 75: 103789, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1587925
ABSTRACT

BACKGROUND:

The long-term consequences of human umbilical cord-derived mesenchymal stem cell (UC-MSC) treatment for COVID-19 patients are yet to be reported. This study assessed the 1-year outcomes in patients with severe COVID-19, who were recruited in our previous UC-MSC clinical trial.

METHODS:

In this prospective, longitudinal, cohort study, 100 patients enrolled in our phase 2 trial were prospectively followed up at 3-month intervals for 1 year to evaluate the long-term safety and effectiveness of UC-MSC treatment. The primary endpoint was an altered proportion of whole-lung lesion volumes measured by high-resolution CT. Other imaging outcomes, 6 min walking distance (6-MWD), lung function, plasma biomarkers, and adverse events were also recorded and analyzed. This trial was registered with ClinicalTrials.gov (NCT04288102).

FINDINGS:

MSC administration improved in whole-lung lesion volume compared with the placebo with a difference of -10.8% (95% CI -20.7%, -1.5%, p = 0.030) on day 10. MSC also reduced the proportion of solid component lesion volume compared with the placebo at each follow-up point. More interestingly, 17.9% (10/56) of patients in the MSC group had normal CT images at month 12, but none in the placebo group (p = 0.013). The incidence of symptoms was lower in the MSC group than in the placebo group at each follow-up time. Neutralizing antibodies were all positive, with a similar median inhibition rate (61.6% vs. 67.6%) in both groups at month 12. No difference in adverse events at the 1-year follow-up and tumor markers at month 12 were observed between the two groups.

INTERPRETATION:

UC-MSC administration achieves a long-term benefit in the recovery of lung lesions and symptoms in COVID-19 patients.

FUNDING:

The National Key R&D Program of China, the Innovation Groups of the National Natural Science Foundation of China, and the National Science and Technology Major Project.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Mesenchymal Stem Cell Transplantation / Mesenchymal Stem Cells / COVID-19 Type of study: Controlled clinical trial / Observational study / Prognostic study / Randomized controlled trials / Risk factors Topics: Long Covid Limits: Aged / Female / Humans / Male / Middle aged Language: English Journal: EBioMedicine Year: 2022 Document Type: Article Affiliation country: J.ebiom.2021.103789

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Mesenchymal Stem Cell Transplantation / Mesenchymal Stem Cells / COVID-19 Type of study: Controlled clinical trial / Observational study / Prognostic study / Randomized controlled trials / Risk factors Topics: Long Covid Limits: Aged / Female / Humans / Male / Middle aged Language: English Journal: EBioMedicine Year: 2022 Document Type: Article Affiliation country: J.ebiom.2021.103789