HRCT pulmonary fibrotic lesions
Conditions
Interventions
Experimental Group:Test preparation (human umbilical cord mesenchymal stem cell extracellular vesicles aerosol)
Control Group:Control preparation (physiological saline)
Sponsors
Linyi People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 75 years old (inclusive), any gender; 2. Meet HRCT criteria for pulmonary fibrotic lesions: (1) Manifested as linear, stiff high-density shadows or nodular high-density shadows in the lungs. (2) Manifested as diffusely distributed reticular, linear, honeycomb shadows or reticular nodular shadows in both lungs. 3. Typical imaging manifestations of pulmonary fibrotic lesions on HRCT within the past 12 weeks, including patients with idiopathic pulmonary fibrosis, mid-to-late stage COPD, or imaging changes caused by long-term cough after COVID-19; 4. Able to understand and cooperate with pulmonary function test procedures; 5. Fully informed about the purpose, methods, and possible discomfort of the trial, agree to participate, and voluntarily sign the informed consent form; 6. Good compliance, willing to take medication according to the protocol and attend follow-up examinations on time.
Exclusion criteria
Exclusion criteria: 1. Previously received stem cell therapy; 2. Individuals who cannot tolerate nebulized inhalation therapy; 3. Allergic constitution or a history of potentially life-threatening drug allergies; 4. Pregnant or recently planned pregnant or lactating women; 5. Male participants with fertility and female participants of childbearing age are unwilling to sign up for effective contraceptive measures during the treatment period until the end of follow-up, totaling 12 months; 6. Individuals with a history of malignant tumors or those who have received systemic anti-cancer treatment within the first 5 years of the screening period; 7. The presence of active hepatitis B or hepatitis C virus infection, or HIV infection; 8. Patients with a history of organ transplantation or waiting for organ transplantation; 9. Those who have undergone surgery within 8 weeks prior to enrollment (excluding diagnostic surgery) or planned surgery during the study period, or whose surgical wounds have not fully healed before enrollment; 1.Individuals who have taken or plan to take Nidanib or Pirfenidone medication for treatment within 10.1 months; 11. Suffering from any of the following lung diseases: bronchial asthma, active pulmonary tuberculosis, pulmonary embolism, pneumothorax, pneumoconiosis, idiopathic pulmonary hypertension, obliterative bronchiolitis, or other active lung diseases; 12. Currently or within the past 4 weeks suffering from pneumonia; 13. Previous lung resection surgery; 14. Those who currently require oxygen therapy and the duration of oxygen therapy is>15 hours/day; 15. Individuals with a history of mental illness, epilepsy, or other central nervous system diseases; 16. Suffering from serious other systemic diseases, such as myocardial infarction, unstable angina, heart failure, liver cirrhosis, acute glomerulonephritis, etc; 17. Screening subjects who have participated in any other clinical trials within the first three months; 18. Currently participating in other clinical trials; 19. Poor compliance makes it difficult for researchers to complete the research; 20. Any situation that the researcher believes may increase the risk to the subjects or interfere with the trial results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HRCT;Vital Signs and general physical examination;Blood routine, urine routine, blood biochemistry, electrocardiogram, finger Oxygenation, tumor markers, IL-6, IL-10 peripheral blood immune cell function, peripheral blood lymphocyte subsets;lung function;St. George's Respiratory Questionnaire; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6 minutes walking distance;mMRC dyspnea scale; | — |
Countries
China
Contacts
Public ContactWei Li
Linyi People's Hospital
Outcome results
None listed