Clinical trial NCT04336254: Safety and Efficacy Study of Allogeneic Human Dental Pulp Mesenchymal Stem Cells to Treat Severe COVID-19 Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: COVID-19
Keywords: Cronovirus
Human Dental Pulp Stem Cells
Dental Stem Cell Banking
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
Collaborators: name: Beijing SH Bio-Tech Corporation, Beijing (CN)
name: Utooth Biological Technology Co., Ltd. Hubei (CN)
First posted: 2020-04-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 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.

Primary outcomes:
measure: TTCI
timeFrame: 1-28 days
Secondary outcomes:
measure: Lung lesion
timeFrame: 1-28 days
measure: Immune function
timeFrame: 1-28 days
measure: Time of SARS-CoV-2 clearance
timeFrame: 1-28 days
measure: Blood test
timeFrame: 1-28 days
measure: SPO2
timeFrame: 1-28 days
measure: RR
timeFrame: 1-28 days
measure: Body temperature
timeFrame: 1-28 days
measure: Side effects in the treatment group
timeFrame: 1-28 days
measure: C-reactive protein (mg/L)
timeFrame: 1-28 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University (East Campus)
state: Hubei
Study officials:
affiliation: Center for Regenerative Medicine, Renmin Hospital of Wuhan University
name: Prof. Qingsong Ye, PhD,DDS
role: STUDY_CHAIR
References:
citation: Ye Q, Wang H, Xia X, Zhou C, Liu Z, Xia ZE, Zhang Z, Zhao Y, Yehenala J, Wang S, Zhou G, Hu K, Wu B, Wu CT, Wang S, He Y. Safety and efficacy assessment of allogeneic human dental pulp stem cells to treat patients with severe COVID-19: structured summary of a study protocol for a randomized controlled trial (Phase I / II). Trials. 2020 Jun 12;21(1):520. doi: 10.1186/s13063-020-04380-5.