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Safety and Efficacy Study of Allogeneic Human Dental Pulp Mesenchymal Stem Cells to Treat Severe novel coronavirus pneumonia (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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031319
Enrollment
Unknown
Registered
2020-03-27
Start date
2020-04-01
Completion date
Unknown
Last updated
2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

hDPSCs group:Routine treatment + Intravenous injection of human dental pulp stem cells
Control group:Routine treatment + Placebo

Sponsors

Renmin Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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 changes in lung.

Exclusion criteria

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 inappropriate for participating in this clinical trial.

Design outcomes

Primary

MeasureTime frame
TTCI;—

Secondary

MeasureTime frame
Immune biomarkers;Degree of Lung Lesion by CT;Time of SARS-CoV-2 test turns negative;Blood test;SPO2;RR;Body temperature;Biochemical tests;—

Countries

China

Contacts

Public ContactProf. Qingsong Ye; Dr. Chenliang Zhou

Center for Regenerative Medicine, Renmin Hospital of Wuhan University

20215851@qq.com+86 027 88041919-83920

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 27, 2026