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

NCT04336254 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-03-10

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

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

Intravenous injection of 3.0x10e7 human dental pulp stem cells solution (30ml) on day 1, day 4 and day 7, based on routine treatment of COVID-19

OTHER

Intravenous saline injection (Placebo)

Intravenous injection of 3ml of 0.9% saline on day 1, day 4 and day 7, based on routine treatment of COVID-19

Sponsors & Collaborators

  • Beijing SH Bio-Tech Corporation, Beijing (CN)

    collaborator UNKNOWN

  • Utooth Biological Technology Co., Ltd. Hubei (CN)

    collaborator UNKNOWN

  • Renmin Hospital of Wuhan University

    lead OTHER

Principal Investigators

  • Prof. Qingsong Ye, PhD,DDS · Center for Regenerative Medicine, Renmin Hospital of Wuhan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-05-06
Primary Completion
2021-11-30
Completion
2021-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT04336254 on ClinicalTrials.gov