Treatment With Human Umbilical Cord-derived Mesenchymal Stem Cells for Severe Corona Virus Disease 2019 (COVID-19)

NCT04288102 | Completed Phase 2

• 1 other identifier: 2020-013-D
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Corona Virus Disease 2019(COVID-19)

Outcome Measures

Primary Outcomes (1)

• Change in lesion proportion (%) of full lung volume from baseline to day 28.

  Evaluation of Pneumonia Improvement

  Day 28

Secondary Outcomes (19)

• Change in lesion proportion (%) of full lung volume from baseline to day 10 and 90

  Day 10, Day 90

• Change in consolidation lesion proportion (%) of full lung volume from baseline to day 10, 28 and 90.

  Day 10, Day 28, Day 90

• Change in ground-glass lesion proportion (%) of full lung volume from baseline to day 10, 28 and 90.

  Day 10, Day 28, Day 90

• Pulmonary fibrosis - related morphological features in CT scan at day 90 a. cord-like shadow b. honeycomb-like shadows c. interlobular septal thickening d. intralobular interstitial thickening e. pleural thickening

  Day 90

• Lung densitometry: Change in total voxel 'weight' in lesion area voxel 'weight'=voxel density (in HU) × voxel volume (in voxel)

  Day 10, Day 28, Day 90

Study Arms (2)

Human Umbilical Cord-Mesenchymal Stem Cells (UC-MSCs)

EXPERIMENTAL

Participants will receive standard of care plus 3 does of UC-MSCs

Biological: UC-MSCs

Placebo

PLACEBO COMPARATOR

Participants will receive standard of care plus 3 does of placebo

Biological: Saline containing 1% Human serum albumin（solution without UC-MSCs）

Interventions

UC-MSCs BIOLOGICAL

3 does of UC-MSCs(4.0\*10E7 cells per time) intravenously at Day 0, Day 3, Day 6.

Human Umbilical Cord-Mesenchymal Stem Cells (UC-MSCs)

Saline containing 1% Human serum albumin（solution without UC-MSCs） BIOLOGICAL

3 does of placebo（intravenously at Day 0, Day 3, Day 6）

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged at 18 years (including) -75 years old
• Hospitalized
• Laboratory confirmation of SARS-CoV-2 infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source
• Pneumonia that is judged by computed tomography
• In accordance with any one of the following : 1)dyspnea (RR ≥ 30 times / min), 2)finger oxygen saturation ≤ 93% in resting state, 3)arterial oxygen partial pressure (PaO2) / oxygen absorption concentration (FiO2) ≤ 300MMHG, 4)pulmonary imaging shows that the focus progress \> 50% in 24-48 hours
• Interstitial lung damage is judged by computed tomography.

You may not qualify if:

• Pregnancy, lactation and those who are not pregnant but do not take effective contraceptives measures;
• Patients with malignant tumor, other serious systemic diseases and psychosis;
• Patients who are participating in other clinical trials;
• Inability to provide informed consent or to comply with test requirements.
• Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus.
• Invasive ventilation
• Shock
• Combined with other organ failure( need organ support)
• Interstitial lung damage caused by other reasons ( in 2 weeks)
• The pulmonary imaging revealed the interstitial damage of lungs before the COVID-19 confirmed.

Sponsors & Collaborators

• Beijing 302 Hospital: lead
• Huoshenshan Hospital: collaborator
• Maternal and Child Health Hospital of Hubei Province: collaborator
• The General Hospital of Central Theater Command: collaborator
• Vcanbio Cell and Gene Engineering Corp., Ltd.: collaborator

Study Sites (3)

General Hospital of Central Theater Command

Wuhan, Hubei, 430000, China

Location

Maternal and Child Hospital of Hubei Province

Wuhan, Hubei, 430000, China

Location

Wuhan Huoshenshan Hospital

Wuhan, Hubei, 430000, China

Location

Related Publications (4)

• 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.

  PMID: 40001244 DERIVED

• 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.

  PMID: 37149930 DERIVED

• 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.

  PMID: 34963099 DERIVED

• 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.

  PMID: 33568628 DERIVED

Study Officials

• Fu-Sheng Wang, MD, PhD

  Beijing 302 Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Treatment and Research Center for Infectious Diseases, Principle Investigator, Clinical Professor

Model Details: Randomized, double-blind, placebo-controlled study

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 28, 2020
• Study Start: March 5, 2020
• Primary Completion: May 12, 2020
• Study Completion: July 9, 2020
• Last Updated: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (3)