Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Long COVID-19: a Randomized, Double-blind, Parallel-controlled Study

DFSC-2023(CR)-02

To explore the efficacy and safety of Umbilical cord mesenchymal stem cells in the treatment of long COVID-19

2023-04-01

2023-12-01

2024-03-30

Withdrawn

Early phase I

Inclusion Criteria: 1. The age ranges from 18 to 85 (inclusive), regardless of gender. 2. Patients with Confirmed SARS-CoV-2 infection, according to the consensus of the Chinese diagnostic criteria for COVID-19 (Tentative tenth Edition). 3. Patients with symptoms of long COVID-19 3 months from the onset of COVID-19, lasting for at least 2 months, and the symptoms cannot be explained by other diseases. 4. Be expected to live longer than 1 year. 5. Volunteer to participate in this clinical study and sign the written informed consent. Exclusion Criteria: 1. Those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation. 2. T lymphocyte abnormality, HIV positive. 3. Highly allergic or have a history of severe allergy. 4. Pregnant and lactating women. 5. Patients with severe autoimmune disease history; 6. Patients with uncontrolled chronic diseases or serious complications; 7. Patients with malignant tumors; 8. Patients with pulmonary embolism, acute coronary syndrome, cerebral embolism or at high risk of thromboembolism; 9. Patients with severe organ dysfunction 10. Other situations that the researchers think are not suitable for participating in this study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2023-11-21