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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04336254
• Other study ID #: 2020K-G005
• Secondary ID: hDPSC-CoVID-2019
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 6, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: Renmin Hospital of Wuhan University
• Contact: Qingsong Ye, PhD,DDS
• Phone: +8615858242516
• Email: qingsongye[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
China	Renmin Hospital of Wuhan University (East Campus)	Wuhan	Hubei

Sponsors (3)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University	Beijing SH Bio-Tech Corporation, Beijing (CN), Utooth Biological Technology Co., Ltd. Hubei (CN)

Country where clinical trial is conducted

China, 

Outcome

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