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

Phase 1

• Conditions: COVID-19
• Interventions: Biological: allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC); Other: Intravenous saline injection (Placebo)

• Registration Number: NCT04336254
• Lead Sponsor: Renmin Hospital of Wuhan University

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 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.

Study Timeline

• Study First Submitted: 2020-03-28
• Study First Submitted QC: 2020-04-03
• Study First Posted: 2020-04-07
• Study Start: 2020-05-06
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-10
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hDPSCs group	allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC)	Routine treatment + Intravenous injection of human dental pulp stem cells
Control group	Intravenous saline injection (Placebo)	Routine treatment + Intravenous saline injection (Placebo)

Primary Outcome Measures

Name	Time	Method
TTCI	1-28 days	Time to Clinical Improvement

Secondary Outcome Measures

Name	Time	Method
SPO2	1-28 days	Pulse oximetry
Lung lesion	1-28 days	Lung Lesion by CT
Body temperature	1-28 days	Body temperature
Blood test	1-28 days	Blood cell count and classification
Side effects in the treatment group	1-28 days	Number of the included patients with hDPSCs-related adverse events, e.g. liver or kidney function failure
Immune function	1-28 days	1. Th1 cytokines: IL-1β, IL- 2, TNF-a, ITN-γ; 2. Th2 cytokines: IL- 4, IL- 6, IL- 10; 3. Immunoglobulins: IgA, IgG, IgM, and total IgE; 4. Lymphocyte counts: CD3+, CD4+, CD8+, CD16+,CD19+, CD56+.
C-reactive protein (mg/L)	1-28 days	C-reactive protein in microgram per litre
Time of SARS-CoV-2 clearance	1-28 days	Time of SARS-CoV-2 test turns negative
RR	1-28 days	Respiratory rate

Trial Locations

Locations (1)

Renmin Hospital of Wuhan University (East Campus); 🇨🇳 Wuhan, Hubei, China