Interstitial Lung Abnormality
Conditions
Interventions
Umbilical Cord Mesenchymal Stem Cell Exosome Inhalation Group:Exosome Inhalation of Umbilical Cord Mesenchymal Stem Cells
Sponsors
The First People's Hospital of Changzhou
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 75 years (inclusive), with no gender restrictions. 2.CT imaging shows non-dependent bilateral lung parenchymal abnormalities, including ground-glass opacities, reticular shadows, lung structural distortion, traction bronchiectasis, and/or honeycombing, with these abnormalities involving more than 5% of the lung area (consistent with ILA diagnosis). 3.Ability to understand and cooperate with lung function tests. 4.Sufficient organ function, with laboratory test results within 7 days prior to treatment initiation meeting the following standards: White blood cell (WBC) count >= 3.5×10^9/L Platelets (PLT) >=80×10^9/L Absolute neutrophil count (ANC) >=1.5×10^9/L Hemoglobin (HGB) >= 90g/L Aspartate aminotransferase (AST) < 2.5× upper limit of normal (ULN) Alanine aminotransferase (ALT) < 2.5×ULN Total bilirubin (TIBC) < 1.5×ULN Serum creatinine (CR) < 1.0×ULN;
Exclusion criteria
Exclusion criteria: 1. Those who cannot tolerate aerosol inhalation therapy; 2. Previous history of severe allergy, acute phase of asthma/airway hyperresponsiveness; 3. Patients with a history of malignant tumor; 4. Known seropositive for HIV, syphilis, active HBV or HCV infection; 5. Suffering from mental illness or other conditions, unable to cooperate with the requirements of research treatment and monitoring; 6. Organ transplant recipients; 7. Pregnant or lactating women; 8. Have received prior stem-cell therapy; 9. Patients with active infection (such as respiratory tract infection, urinary system infection, etc.) within 9.2 weeks or who are currently receiving systemic anti-infection treatment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete blood count, liver and kidney function, blood biochemistry, electrocardiogram, serum tumor markers, peripheral blood lymphocyte subpopulations.;Vital Signs and general physical examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary function test;St. George's Respiratory Questionnaire (SGRQ), Leicester Cough Questionnaire, mMRC Dyspnea Scale.;6 minutes walking distance;Chest CT; | — |
Countries
China
Contacts
Public ContactLi Chong
The First People's Hospital of Changzhou
Outcome results
None listed