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Safety and Efficacy Study of Allogeneic Human Dental Pulp Mesenchymal Stem Cells to Treat Severe COVID-19 Patients | Clinical Trials | Clareo Health

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Safety and Efficacy Study of Allogeneic Human Dental Pulp Mesenchymal Stem Cells to Treat Severe COVID-19 Patients

Safety and Efficacy Study of Allogeneic Human Dental Pulp Mesenchymal Stem Cells to Treat Severe Pneumonia of COVID-19：a Single-center, Prospective, Randomised Clinical Trial

NCT04336254•Renmin Hospital of Wuhan University

View on ClinicalTrials.gov

Summary

This clinical trial is set out to evaluate the safety and efficacy of allogeneic human dental pulp mesenchymal stem cells in the treatment of severe pneumonia caused by COVID-19; to explore the effects of human dental pulp mesenchymal stem cells in the treatment of severe pneumonia of COVID-19 in terms of reducing mortality and improving clinical prognosis; and to discover a new therapeutic strategy for COVID-19 using allogeneic human dental pulp mesenchymal stem cells.

Detailed Description

This clinical trial is set out to evaluate the followings: 1. the safety and efficacy of allogeneic human dental pulp mesenchymal stem cells in the treatment of severe pneumonia caused by COVID-19; 2. to explore the effects of human dental pulp mesenchymal stem cells in the treatment of severe pneumonia of COVID-19 in terms of reducing mortality and improving clinical prognosis; and 3. to discover a new therapeutic strategy for COVID-19 using allogeneic human dental pulp mesenchymal stem cells.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged 18-65 years;
•2. Voluntarily participate in this clinical trial and sign off "informed consent form";
•3. Diagnosed with severe pneumonia of COVID: respiratory distress, RR \>30 times / min; resting oxygen saturation of 93% or less; arterial partial pressure of oxygen / oxygen concentration 300mmHg; SARS-CoV-2 nucleic acid test was positive.
•4. Chest imaging confirm COVID-19 featured lesions in lung.

Exclusion Criteria

•1. Receive any clinical trial drug treatment for COVID-2019 within 30 days before the screening assessment;
•2. Severe liver disease (e.g., Child Pugh score \>=C or AST\> 5 times of the upper limit);
•3. Patients with known severe renal insufficiency (estimated glomerular filtration rate \<=30mL / min/1.73 m2) or patients receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis;
•4. Co-infection of HIV, hepatitis B, tuberculosis, influenza virus, adenovirus or other respiratory infection viruses;
•5. Female patients who have no sexual protection in the last 30 days prior to the screening assessment;
•6. Pregnant or lactating women or women using estrogen contraception;
•7. Patients who are planning to become pregnant during the study period or within 6 months after the end of the study period;
•8. Other conditions that the researchers consider not suitable for participating in this clinical trial.

Locations (1)

Renmin Hospital of Wuhan University (East Campus)

Wuhan, Hubei, China

Key Dates

Start Date

May 6, 2020

Primary Completion Date

November 30, 2021

Completion Date

December 31, 2021

Last Updated

March 10, 2021

Enrollment

ESTIMATED participants

Conditions

COVID-19

Interventions

allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC)

BIOLOGICAL

Intravenous saline injection (Placebo)

OTHER

Contacts

Qingsong Ye, PhD,DDS

CONTACT

+8615858242516 qingsongye@foxmail.com

Chenliang Zhou, PhD

CONTACT

+862788041919

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy Study of Allogeneic Human Dental Pulp Mesenchymal Stem Cells to Treat Severe COVID-19 Patients

Inclusion Criteria

Exclusion Criteria

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