pulmonary fibrosis manifested by HRCT
Conditions
Interventions
Experimental Group:Test preparation (human umbilical cord mesenchymal stem cell exosome aerosol), inhaled twice a day, 2ml each time, adding 6ml of normal saline, nebulized inhalation, 09:00±30min in
Control Group:Control preparation (normal saline) was inhaled twice a day, 8 ml each time, atomized inhalation, 09:00 ± 30 min in the morning and 20:00 ± 30 min in the evening, a course of 7 days.
Sponsors
The First Affiliated Hospital of the Hainan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Aged from 18 to 75 years old (including the critical value), gender is not limited. 2) Consistent with HRCT pulmonary fibrotic lesions: a. Presented as lung cords, rigid high-density shadows or nodular high-density shadows. b. Reticular, linear, honeycomb shadow or reticular nodular shadow diffusely distributed in both lungs. 3) HRCT within the past 12 weeks had typical imaging findings of pulmonary fibrosis. Including patients with chronic cough caused by idiopathic pulmonary fibrosis, COPD with fibrosis, and organizing pneumonia after COVID-19 infection. 4) Able to understand and cooperate with the completion of pulmonary function test operations. 5) They were fully informed of the purpose, method and possible discomfort of the experiment, agreed to participate in the experiment, and voluntarily signed an informed consent form. 6) Good compliance, willing to take medication according to the requirements of the plan and accept follow-up examinations on time.
Exclusion criteria
Exclusion criteria: 1) Have received stem cell therapy in the past. 2) Those who cannot tolerate nebulized inhalation treatment. 3) Allergic constitution or history of drug allergy that may be life-threatening. 4) Women who are pregnant or plan to become pregnant or breastfeeding in the near future. 5) Male subjects of childbearing potential and female subjects of childbearing age are unwilling to take effective contraceptive measures during the treatment period until the end of follow-up for a total of 12 months. 6) Those who have a history of malignant tumors or those who have received systemic anticancer therapy within 5 years before the screening period. 7) 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 before enrollment (except for diagnostic surgery) or plan to undergo surgery during the study period, or those whose surgical wounds have not fully healed before enrollment. 10) Those who are taking or plan to take nintedanib or pirfenidone within 1 month. 11) Suffering from any of the following lung diseases: bronchial asthma, active tuberculosis, pulmonary embolism, pneumothorax, pneumoconiosis, idiopathic pulmonary hypertension, bronchiolitis obliterans or other active lung diseases. 12) Suffering from pneumonia at present or within the past 4 weeks. 13) Previous lung resection. 14) Those who currently need to use oxygen therapy and the oxygen therapy time is >15h/d. 15) Those with a history of mental illness, epilepsy or other central nervous system diseases. 16) Suffering from other serious system diseases, such as myocardial infarction, unstable angina, cardiac insufficiency, liver cirrhosis, acute glomerulonephritis, etc. 17) Select subjects who have participated in any other clinical trials within the first 3 months. 18) Currently participating in other clinical trials. 19) Poor compliance makes it difficult to complete the research. 20) Any situation that the researcher believes may increase the risk of the subject or interfere with the test results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;St. George's Respiratory Questionnaire;lung function;HRCT; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6 minutes walking distance;mMRC dyspnea scale; | — |
Countries
China
Contacts
Public ContactHuang huaping
The First Affiliated Hospital of the Hainan Medical College
Outcome results
None listed