Clinical Study of the Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Exosomes in Treating Chronic Cough After COVID-19 Infection

KY20230214-V04

This clinical trial aims to evaluate the safety and effectiveness of umbilical cord mesenchymal stem cell (UCMSC)-derived extracellular vesicle nebulization inhalation therapy for the treatment of chronic cough after COVID-19 infection. The main objective is to assess whether UCMSC-derived exosome nebulization inhalation therapy alleviates chronic cough after COVID-19. Participants will be asked to complete a questionnaire to help researchers evaluate their cough severity and to record their scores before nebulization inhalation of UCMSC-derived exosomes. Participants will receive either continuous nebulized inhalation of UCMSC-derived exosomes for 5 days, twice daily, or no treatment. Researchers will compare the experimental and control groups to evaluate the safety and efficacy of UCMSC-derived exosomes for the treatment of chronic cough after COVID-19 infection.

2023-02-15

2024-02-15

2025-02-15

Recruiting

Early phase I

80

Inclusion Criteria: * Trial participants voluntarily participate in this study and sign an informed consent form. * At the time of signing the informed consent form, the age of the subject should be ≥18 or ≤80 years old, with no gender restrictions. * The subject has been diagnosed with COVID-19 (confirmed by positive nucleic acid or antigen test) and has symptoms that have lasted for more than 4 weeks. * Negative nucleic acid or antigen test at the time of screening. * The subject has had continuous or intermittent coughing, or loss of taste/smell for ≥4 weeks, which did not occur before the onset of COVID-19 infection. * No prior treatment with umbilical cord mesenchymal stem cell-derived extracellular vesicles. * The patient fully understands the purpose and requirements of this clinical study and is willing to complete all trial procedures according to the study requirements. Exclusion Criteria: * Age ≤18 or ≥80 years old. * Acute COVID-19 patients. * Suspected or confirmed to have severe, active bacterial, fungal, or other infections that may pose a risk when intervention measures are taken, as determined by the researcher. * Patients with a history of diagnosed bronchial asthma, cough variant asthma, or chronic cough; patients with other pulmonary diseases such as chronic obstructive pulmonary disease, bronchiectasis, tuberculosis, lung cancer, etc. * Any of the following during the screening period: 1) ALT or AST \> 3 times the upper limit of normal; 2) eGFR \<60 mL/min. * Patients with a history of severe allergies. * Patients with uncontrolled severe cardiovascular, cerebrovascular, liver, kidney, endocrine, blood system diseases, and mental illness. * Patients with active immunosuppression, immunodeficiency, and use of immunosuppressive drugs. * Pregnant and lactating women. * Other factors that the researcher deems unsuitable for participation in the study based on clinical considerations.

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

2023-04-14