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Status unknownNCT04302519Updated Mar 10, 2020

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

An Early Phase 1 interventional study of Dental pulp mesenchymal stem cells in COVID-19, sponsored by CAR-T (Shanghai) Biotechnology Co., Ltd.. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-03-10.

Sponsored by CAR-T (Shanghai) Biotechnology Co., Ltd. · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study summary

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.

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Conditions studied

  • COVID-19

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03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 24 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

CAR-T (Shanghai) Biotechnology Co., Ltd. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Age ≥ 18, age ≤ 75, gender unlimited;
    1. 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).
    1. 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.

Exclusion criteria

Exclusion Criteria:

    1. Patients with autoimmune diseases in the past or screening;
    1. 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;
    1. Known or self-reported HIV or syphilis infected persons;
    1. Have participated in stem cell clinical research;
    1. Pregnant or lactating women or those who have fertility plans in the past year;
    1. The estimated life cycle is less than 48 hours;
    1. Those who participated in other clinical trials within 3 months before screening;
    1. Other conditions that the researcher thinks are not suitable for participating in the experiment.
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Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Pulp mesenchymal stem cells

    1. 3, 7 days to increase the injection of mesenchymal stem cells

    Biological: Dental pulp mesenchymal stem cells

Interventions

  • BiologicalDental 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.

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What researchers measure

Primary outcomes

  1. Disppear time of ground-glass shadow in the lungs

    Kaplan-meier method was used to calculate the median glassy shadow time in all subjects

    Time frame: 14 days

Secondary outcomes

  1. 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

    Time frame: 7, 14, 28 and 360 days

  2. Changes of blood oxygen

    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

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04302519
Lead sponsor
CAR-T (Shanghai) Biotechnology Co., Ltd.
Responsible party
Sponsor
First posted
Mar 10, 2020
Start date
Mar 5, 2020 (estimated)
Primary completion
Jun 30, 2021 (estimated)
Completion
Jul 30, 2021 (estimated)
Last update
Mar 10, 2020

Study contacts

Xiaoyang Zhou, doctor
Contact
xiaoyangzh@hotmail.com
18986033792
Liwei cheng, doctor
study director · Research office of wuhan renmin university

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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