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Clinical Study of Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells

Trial Profile

Clinical Study of Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells

Status: Not yet recruiting
Phase of Trial: Phase 0

Latest Information Update: 17 Mar 2020

At a glance

  • Drugs Dental pulp derived mesenchymal stem cells Shanghai-Biotechnology (Primary)
  • Indications COVID 2019 infections; Pneumonia
  • Focus Therapeutic Use
  • Sponsors Shanghai Biotechnology
  • Most Recent Events

    • 17 Mar 2020 New trial record

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

  • 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
xiaoyangzh@hotmail.com
show details
-

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
17 Mar 2020 New trial record New trial record Updated 17 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
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