COVID-19Early Phase 1NCT04302519
Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells
A Early Phase 1 study testing Dental pulp mesenchymal stem cells in people with COVID-19, run by CAR-T (Shanghai) Biotechnology Co., Ltd..
Trial summary
Evaluation of novel coronavirus induced severe pneumonia by dental pulp mesenchymal stem cells Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Dental pulp mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2020to 30 Jul 2021
- Phase
- Early Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age ≥ 18, age ≤ 75, gender unlimited;
- 2. novel coronavirus diagnosed severe pneumonia and confirmed no effective treatment plan. (severe patients meet any of the following: (1) respiratory distress, RR > 30 times / minute; (2) resting state, oxygen saturation is less than 93%; (3) arterial oxygen partial pressure (PaO2) / oxygen inhalation (FiO2) is less than 300 mmHg (1mm Hg=0.133 kPa).
- 3. Those who voluntarily participate in the clinical study and can cooperate with researchers to carry out the study, and the patients themselves or their legal representatives voluntarily sign the informed consent.
Who cannot join
- 1. Patients with autoimmune diseases in the past or screening;
- 2. Those who have serious basic diseases that affect their survival, including: malignant tumor, hematopathy, malignant fluid, active hemorrhage, severe malnutrition, etc. which have not been controlled and can not be removed due to multiple metastasis;
- 3. Known or self-reported HIV or syphilis infected persons;
- 4. Have participated in stem cell clinical research;
- 5. Pregnant or lactating women or those who have fertility plans in the past year;
- 6. The estimated life cycle is less than 48 hours;
- 7. Those who participated in other clinical trials within 3 months before screening;
- 8. Other conditions that the researcher thinks are not suitable for participating in the experiment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Study of Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells
Evaluation of novel coronavirus induced severe pneumonia by dental pulp mesenchymal stem cells
Read the detailed description
Open, single center, single arm test design. Plan to enroll 24 subjects. On the basis of clinical standard treatment, the injection of dental mesenchymal stem cells was increased on day 1, 3 and 7 of the trial.
Injection dose: 1.0x106 cells /kg. Injection method: slowly and quietly drop 50 mL of normal saline, then the endodontic mesenchymal stem cell injection (after 60 min), and then 50 mL of normal saline.
- Conditions
- COVID-19
- Being tested
- Dental pulp mesenchymal stem cells
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental pulp mesenchymal stem cellsBiological
On the basis of clinical standard treatment, the injection of dental mesenchymal stem cells was increased on day 1, 3 and 7 of the trial.
| Study group | Role | What they receive |
|---|---|---|
| Pulp mesenchymal stem cells | Experimental | 1. 3, 7 days to increase the injection of mesenchymal stem cells Receives: Biological: Dental pulp mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disppear time of ground-glass shadow in the lungs
Kaplan-meier method was used to calculate the median glassy shadow time in all subjects
Measured: 14 days
Secondary outcomes (2)
Absorption of Lung shadow absorption by CT Scan-Chest
Kaplan-meier method was used to calculate the median lung shadow absorption of all subjects on 7, 14, 28, and 360 days
Measured: 7, 14, 28 and 360 days
Changes of blood oxygen
T test was used to compare the blood oxygen values of each subject at day 3, 7 and 14
Measured: 3, 7 and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start5 Mar 2020 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dental pulp mesenchymal stem cells were injected intravenously
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CAR-T (Shanghai) Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liwei cheng, doctor, Study director, Research office of wuhan renmin university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302519
- Sponsor's protocol ID
- KT005HB001
- Status last verified
- Feb 2020
- First submitted
- 27 Feb 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT04302519
- Acronym / sponsor ID
- KT005HB001
- Conditions
- COVID-19
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- CAR-T (Shanghai) Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2020 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 10 Mar 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.
Evaluation of novel coronavirus induced severe pneumonia by dental pulp mesenchymal stem cells
Detailed description
Open, single center, single arm test design. Plan to enroll 24 subjects. On the basis of clinical standard treatment, the injection of dental mesenchymal stem cells was increased on day 1, 3 and 7 of the trial.
Injection dose: 1.0x106 cells /kg. Injection method: slowly and quietly drop 50 mL of normal saline, then the endodontic mesenchymal stem cell injection (after 60 min), and then 50 mL of normal saline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dental pulp mesenchymal stem cells were injected intravenously
| Arm | Type | Receives |
|---|---|---|
| Pulp mesenchymal stem cells | Experimental | Biological: Dental pulp mesenchymal stem cells1. 3, 7 days to increase the injection of mesenchymal stem cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Age ≥ 18, age ≤ 75, gender unlimited;
- 2. novel coronavirus diagnosed severe pneumonia and confirmed no effective treatment plan. (severe patients meet any of the following: (1) respiratory distress, RR > 30 times / minute; (2) resting state, oxygen saturation is less than 93%; (3) arterial oxygen partial pressure (PaO2) / oxygen inhalation (FiO2) is less than 300 mmHg (1mm Hg=0.133 kPa).
- 3. Those who voluntarily participate in the clinical study and can cooperate with researchers to carry out the study, and the patients themselves or their legal representatives voluntarily sign the informed consent.
Key exclusion criteria (8 listed)
- 1. Patients with autoimmune diseases in the past or screening;
- 2. Those who have serious basic diseases that affect their survival, including: malignant tumor, hematopathy, malignant fluid, active hemorrhage, severe malnutrition, etc. which have not been controlled and can not be removed due to multiple metastasis;
- 3. Known or self-reported HIV or syphilis infected persons;
- 4. Have participated in stem cell clinical research;
- 5. Pregnant or lactating women or those who have fertility plans in the past year;
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 |
|---|---|---|
| Dental pulp mesenchymal stem cellsOn the basis of clinical standard treatment, the injection of dental mesenchymal stem cells was increased on day 1, 3 and 7 of the trial. | Biological | Pulp mesenchymal stem cells |
Primary outcome
Disppear time of ground-glass shadow in the lungs
Time frame: 14 days
Kaplan-meier method was used to calculate the median glassy shadow time in all subjects
2 secondary outcomes
Absorption of Lung shadow absorption by CT Scan-Chest
Time frame: 7, 14, 28 and 360 days
Changes of blood oxygen
Time frame: 3, 7 and 14 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 2020.
- 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.
Liwei cheng, doctor study director
Research office of wuhan renmin university
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dental pulp mesenchymal stem cells in people with COVID-19, run by CAR-T (Shanghai) Biotechnology Co., Ltd..
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 3 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 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Xiaoyang Zhou, doctor (18986033792, xiaoyangzh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disppear time of ground-glass shadow in the lungs (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2020.