Clinical Study of Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells
Latest Information Update: 03 Feb 2022
At a glance
- Drugs Dental pulp derived mesenchymal stem cells Shanghai-Biotechnology (Primary)
- Indications COVID 2019 infections; Pneumonia
- Focus Therapeutic Use
- Sponsors Shanghai Biotechnology
- 17 Mar 2020 New trial record
Most Recent Events
Trial Overview
Purpose
Evaluation of novel coronavirus induced severe pneumonia by dental pulp mesenchymal stem cells
Primary Endpoints
Disppear time of ground-glass shadow in the lungs
description: Kaplan-meier method was used to calculate the median glassy shadow time in all subjects
time_frame: 14 days
Other Endpoints
Absorption of Lung shadow absorption by CT Scan-Chest
description: Kaplan-meier method was used to calculate the median lung shadow absorption of all subjects on 7, 14, 28, and 360 days
time_frame: 7, 14, 28 and 360 days
Changes of blood oxygen
description: T test was used to compare the blood oxygen values of each subject at day 3, 7 and 14
time_frame: 3, 7 and 14 days [1]
Diseases Treated
Indication | Qualifiers | Patient Segments |
---|---|---|
COVID 2019 infections | treatment | - |
Pneumonia | treatment | severe |
Subjects
- Subject Type patients
-
Number
Planned: 24
- Sex male & female
- Age Group 18-75 years; adult; elderly
Patient Inclusion Criteria
- 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.
Patient Exclusion Criteria
- 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 Details
Identifiers
Identifier | Owner |
---|---|
NCT04302519 | ClinicalTrials.gov: US National Institutes of Health |
KT005HB001 | - |
Organisations
- Sponsors Shanghai Biotechnology
- Affiliations Shanghai Biotechnology
Trial Dates
-
Initiation Dates
Planned : 05 Mar 2020
Actual : 05 Mar 2020
-
Primary Completion Dates
Planned : 30 Jun 2021
-
End Dates
Planned : 30 Jul 2021
Other Details
- Design open; prospective
- Phase of Trial Phase 0
- Location Unknown
- Focus Therapeutic Use
Interventions
Drugs | Route | Formulation |
---|---|---|
Dental pulp derived mesenchymal stem cells Shanghai-BiotechnologyPrimary Drug | Intravenous | Injection |
Pulp mesenchymal stem cells
1. 3, 7 days to increase the injection of mesenchymal stem cells
Biological: Dental pulp mesenchymal stem cells (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.)
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
Liwei cheng, doctor | Research office of wuhan renmin university |
-
|
Xiaoyang Zhou, doctor
18986033792
show details
xiaoyangzh@hotmail.com |
-
|
Centres
Centre Name | Location | Trial Centre Country |
---|---|---|
- |
-
|
-
|
CAR-T (Shanghai) Biotechnology Co., Ltd. |
-
|
-
|
Research office of wuhan renmin university |
-
|
-
|
Trial History
Event Date | Event Type | Comment |
---|---|---|
03 Feb 2022 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 03 Feb 2022 |
03 Feb 2022 | Other trial event | According to ClinicalTrials.gov record, the recruitment status of this study is unknown because the information has not been verified recently(Last verified 9 March 2020). Updated 03 Feb 2022 |
17 Mar 2020 | New trial record | New trial record Updated 17 Mar 2020 |
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov
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