Status:
UNKNOWN
Safety and Efficacy Study of Allogeneic Human Dental Pulp Mesenchymal Stem Cells to Treat Severe COVID-19 Patients
Lead Sponsor:
Renmin Hospital of Wuhan University
Collaborating Sponsors:
Beijing SH Bio-Tech Corporation, Beijing (CN)
Utooth Biological Technology Co., Ltd. Hubei (CN)
Conditions:
COVID-19
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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 effect...
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...
Eligibility Criteria
Inclusion
- Aged 18-65 years;
- Voluntarily participate in this clinical trial and sign off "informed consent form";
- 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.
- Chest imaging confirm COVID-19 featured lesions in lung.
Exclusion
- Receive any clinical trial drug treatment for COVID-2019 within 30 days before the screening assessment;
- Severe liver disease (e.g., Child Pugh score \>=C or AST\> 5 times of the upper limit);
- 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;
- Co-infection of HIV, hepatitis B, tuberculosis, influenza virus, adenovirus or other respiratory infection viruses;
- Female patients who have no sexual protection in the last 30 days prior to the screening assessment;
- Pregnant or lactating women or women using estrogen contraception;
- Patients who are planning to become pregnant during the study period or within 6 months after the end of the study period;
- Other conditions that the researchers consider not suitable for participating in this clinical trial.
Key Trial Info
Start Date :
May 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04336254
Start Date
May 6 2020
End Date
December 31 2021
Last Update
March 10 2021
Active Locations (1)
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1
Renmin Hospital of Wuhan University (East Campus)
Wuhan, Hubei, China