COVID-19Phase 1/2NCT04336254
Safety and Efficacy Study of Allogeneic Human Dental Pulp Mesenchymal Stem Cells to Treat Severe COVID-19 Patients
A Phase 1/2 study testing allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC) in people with COVID-19, run by Renmin Hospital of Wuhan University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19
- What is being tested?
- allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2020to 31 Dec 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Chenliang Zhou, PhD contact
China1 site, 1 recruiting
- Recruiting
Renmin Hospital of Wuhan University (East Campus)
Wuhan, Hubei
Chenliang Zhou, PhD, +86 027 88041919 ext. 83920
About this study
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
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.
Read the detailed description
This clinical trial is set out to evaluate the followings:
- 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.
- Conditions
- COVID-19
- Being tested
- allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC), Intravenous saline injection (Placebo)
- Keywords
- Cronovirus, Human Dental Pulp Stem Cells, Dental Stem Cell Banking
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC)Biological
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 saline injection (Placebo)Other
Intravenous injection of 3ml of 0.9% saline on day 1, day 4 and day 7, based on routine treatment of COVID-19
| Study group | Role | What they receive |
|---|---|---|
| hDPSCs group | Experimental | Routine treatment + Intravenous injection of human dental pulp stem cells Receives: Biological: allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC) |
| Control group | Placebo comparator | Routine treatment + Intravenous saline injection (Placebo) Receives: Other: Intravenous saline injection (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
TTCI
Time to Clinical Improvement
Measured: 1-28 days
Secondary outcomes (9)
Lung lesion
Lung Lesion by CT
Measured: 1-28 days
Immune function
- Th1 cytokines: IL-1β, IL- 2, TNF-a, ITN-γ;
- Th2 cytokines: IL- 4, IL- 6, IL- 10;
- Immunoglobulins: IgA, IgG, IgM, and total IgE;
- Lymphocyte counts: CD3+, CD4+, CD8+, CD16+,CD19+, CD56+.
Measured: 1-28 days
Time of SARS-CoV-2 clearance
Time of SARS-CoV-2 test turns negative
Measured: 1-28 days
Blood test
Blood cell count and classification
Measured: 1-28 days
SPO2
Pulse oximetry
Measured: 1-28 days
RR
Respiratory rate
Measured: 1-28 days
Body temperature
Body temperature
Measured: 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
Measured: 1-28 days
C-reactive protein (mg/L)
C-reactive protein in microgram per litre
Measured: 1-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start6 May 2020
- Primary completion30 Nov 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing SH Bio-Tech Corporation, Beijing (CN), Utooth Biological Technology Co., Ltd. Hubei (CN)
- Responsible party
- Principal investigator, Ye Qingsong, Renmin Hospital of Wuhan University
- Investigators
- Prof. Qingsong Ye, PhD,DDS, Study chair, Center for Regenerative Medicine, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336254
- Sponsor's protocol ID
- 2020K-G005
- Other IDs
- hDPSC-CoVID-2019-02-2020
- Status last verified
- Mar 2021
- First submitted
- 28 Mar 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32532356
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04336254
- Acronym / sponsor ID
- 2020K-G005
- Conditions
- COVID-19
- Keywords
- Cronovirus, Human Dental Pulp Stem Cells, Dental Stem Cell Banking
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Collaborators
- Beijing SH Bio-Tech Corporation, Beijing (CN), Utooth Biological Technology Co., Ltd. Hubei (CN)
- Study start
- 6 May 2020 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hDPSCs group | Experimental | Biological: allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC)Routine treatment + Intravenous injection of human dental pulp stem cells |
| Control group | Placebo comparator | Other: Intravenous saline injection (Placebo)Routine treatment + Intravenous saline injection (Placebo) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | hDPSCs group |
| 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 | Other | Control group |
Primary outcome
TTCI
Time frame: 1-28 days
Time to Clinical Improvement
9 secondary outcomes
Lung lesion
Time frame: 1-28 days
Immune function
Time frame: 1-28 days
Time of SARS-CoV-2 clearance
Time frame: 1-28 days
Blood test
Time frame: 1-28 days
SPO2
Time frame: 1-28 days
RR
Time frame: 1-28 days
Body temperature
Time frame: 1-28 days
Side effects in the treatment group
Time frame: 1-28 days
C-reactive protein (mg/L)
Time frame: 1-28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Derived from this study: PubMed 32532356Ye 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chenliang Zhou, PhD contact
Prof. Qingsong Ye, PhD,DDS study chair
Center for Regenerative Medicine, Renmin Hospital of Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC) in people with COVID-19, run by Renmin Hospital of Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qingsong Ye, PhD,DDS (+8615858242516, qingsongye@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TTCI (time frame: 1-28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04336254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.