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Safety and Effectiveness of Human embryonic stem cell-derived M cells (CAStem) for Pulmonary Fibrosis Correlated with novel coronavirus pneumonia (COVID-19)

Safety and Effectiveness of Human embryonic stem cell-derived M cells (CAStem) for Pulmonary Fibrosis Correlated with novel coronavirus pneumonia(COVID-19)

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031139
Enrollment
Unknown
Registered
2020-03-22
Start date
2020-03-20
Completion date
Unknown
Last updated
2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Case series:The cell dose was 3*10^6 cells / kg. It was intravenously infused twice in a row, and the interval between each infusion was 1 week (+/-2 days). If the investigator considered it necessary

Sponsors

Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years old; 2. Patients diagnosed with novel coronavirus pneumonia (COVID-19); 3. Patients >=21 days since the first symptoms ; 4. The diagnosis of pulmonary fibrosis is based on the chest CT (such as fibrotic changes in multiple lungs with patchy ground glass or with consolidation, lobular septal thickening, grid, stripe shadow, etc.) or other examination results; 5. The subject must meet at least one of the following two criteria: (1) Pulmonary function examination, showing restricted ventilation dysfunction and / or impaired gas exchange, FVC 70%, DLCO <80% predicted value; (2) Shortness of breath after exercise or need oxygen therapy support; 6. Voluntarily participate in this study, agree to comply with the requirements of the clinical research protocol, and sign an informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who are using invasive mechanical ventilation for respiratory support; 2. Patients with recent hemodynamic instability requiring maintenance of vasoactive drugs and determined by the investigator to be unsuitable to participate in this clinical study; 3. Patients with other severe basic lung diseases, such as active tuberculosis, bronchiectasis, chronic obstructive pulmonary disease, pulmonary hypertension, and damaged lungs, etc., and the researchers judge that they are not suitable to participate in this clinical study; 4. Complicated with severe vascular diseases, such as severe cardiac dysfunction (cardiac function ?, ?), or suffered from acute coronary syndrome, acute cerebrovascular event, deep vein thrombosis or pulmonary embolism within 6 months before enrollment, and Researchers judge it inappropriate to participate in this study; 5. Poorly controlled hypertension, diabetes, severe liver, kidney, coagulation dysfunction, or the effects of other diseases, and it is not appropriate for the study to be judged by the researcher; 6. Those with malignant tumors or pathology suggesting a history of severe atypical hyperplasia; 7. Positive test for human immunodeficiency virus (HIV) antibody, hepatitis C virus antibody, Treponema pallidum antibody, and patients with active infectious diseases that other researchers consider unsuitable to participate in this study; 8. Have a history of severe drug allergies, or are allergic to the main active ingredients or excipients of clinical research products; 9. Those who have previously received cell therapy or organ transplants; 10. Women who are pregnant or nursing or plan to become pregnant during the study, or women or men of childbearing age who are unwilling to take contraception throughout the study; 11. Patients who have been treated with other clinical research products within 28 days before starting treatment, and the researcher determines that the relevant clinical research products will interfere with the evaluation of the safety and effectiveness of this clinical research product; 12. The investigator believes that patients participating in this study are not in the best interest or are not suitable for other conditions such as poor compliance.

Design outcomes

Primary

MeasureTime frame
Pulmonary function evaluation;Changes in blood gas analysis;Evaluation of activity;Evaluation of dyspnea;CT changes from baseline;

Secondary

MeasureTime frame
Evaluation of life quality ;Evaluation of mental health;Blood immune factor test;

Countries

China

Contacts

Public ContactZhang Dingyu

Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital)

1813886398@qq.com+86 13507117929

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026