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

CAR-T Biotechnology

Status and phase

Unknown

Early Phase 1

Conditions

COVID-19

Treatments

Biological: Dental pulp mesenchymal stem cells

Study type

Interventional

Funder types

Industry

Identifiers

NCT04302519

KT005HB001

Details and patient eligibility

About

Evaluation of novel coronavirus induced severe pneumonia by dental pulp mesenchymal stem cells

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

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.