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

NCT04288102 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-08-19

No results posted yet for this study

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)

Interventions

BIOLOGICAL

UC-MSCs

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

BIOLOGICAL

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

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

Sponsors & Collaborators

  • Huoshenshan Hospital

    collaborator OTHER

  • Maternal and Child Health Hospital of Hubei Province

    collaborator OTHER

  • The General Hospital of Central Theater Command

    collaborator OTHER

  • Vcanbio Cell and Gene Engineering Corp., Ltd.

    collaborator INDUSTRY

  • Beijing 302 Hospital

    lead OTHER

Principal Investigators

  • Fu-Sheng Wang, MD, PhD · Beijing 302 Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-05
Primary Completion
2020-05-12
Completion
2020-07-09

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04288102 on ClinicalTrials.gov