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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
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
Intravenous injection of 3ml of 0.9% saline on day 1, day 4 and day 7, based on routine treatment of COVID-19
Renmin Hospital of Wuhan University (East Campus)
Wuhan, Hubei, China
RECRUITINGTTCI
Time to Clinical Improvement
Time frame: 1-28 days
Lung lesion
Lung Lesion by CT
Time frame: 1-28 days
Immune function
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+.
Time frame: 1-28 days
Time of SARS-CoV-2 clearance
Time of SARS-CoV-2 test turns negative
Time frame: 1-28 days
Blood test
Blood cell count and classification
Time frame: 1-28 days
SPO2
Pulse oximetry
Time frame: 1-28 days
RR
Respiratory rate
Time frame: 1-28 days
Body temperature
Body temperature
Time frame: 1-28 days
Side effects in the treatment group
Number of the included patients with hDPSCs-related adverse events, e.g. liver or kidney function failure
Time frame: 1-28 days
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C-reactive protein (mg/L)
C-reactive protein in microgram per litre
Time frame: 1-28 days