Safety and Efficacy Study of Allogeneic Human Dental Pulp Mesenchymal Stem Cells to Treat Severe COVID-19 Patients
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 covid19
Started May 2020
Longer than P75 for phase_1 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2020
CompletedFirst Posted
Study publicly available on registry
April 7, 2020
CompletedStudy Start
First participant enrolled
May 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMarch 10, 2021
March 1, 2021
1.6 years
March 28, 2020
March 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
TTCI
Time to Clinical Improvement
1-28 days
Secondary Outcomes (9)
Lung lesion
1-28 days
Immune function
1-28 days
Time of SARS-CoV-2 clearance
1-28 days
Blood test
1-28 days
SPO2
1-28 days
- +4 more secondary outcomes
Study Arms (2)
hDPSCs group
EXPERIMENTALRoutine treatment + Intravenous injection of human dental pulp stem cells
Control group
PLACEBO COMPARATORRoutine treatment + Intravenous saline injection (Placebo)
Interventions
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
Eligibility Criteria
You may qualify if:
- Aged 18-65 years;
- Voluntarily participate in this clinical trial and sign off "informed consent form";
- 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.
- Chest imaging confirm COVID-19 featured lesions in lung.
You may not qualify if:
- Receive any clinical trial drug treatment for COVID-2019 within 30 days before the screening assessment;
- Severe liver disease (e.g., Child Pugh score \>=C or AST\> 5 times of the upper limit);
- 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;
- Co-infection of HIV, hepatitis B, tuberculosis, influenza virus, adenovirus or other respiratory infection viruses;
- Female patients who have no sexual protection in the last 30 days prior to the screening assessment;
- Pregnant or lactating women or women using estrogen contraception;
- Patients who are planning to become pregnant during the study period or within 6 months after the end of the study period;
- Other conditions that the researchers consider not suitable for participating in this clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Renmin Hospital of Wuhan University (East Campus)
Wuhan, Hubei, China
Related Publications (1)
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.
PMID: 32532356DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Prof. Qingsong Ye, PhD,DDS
Center for Regenerative Medicine, Renmin Hospital of Wuhan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Director
Study Record Dates
First Submitted
March 28, 2020
First Posted
April 7, 2020
Study Start
May 6, 2020
Primary Completion
November 30, 2021
Study Completion
December 31, 2021
Last Updated
March 10, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share