Post-infectious organizing pneumonia
Conditions
Interventions
Control group:Saline
Treatment group:Nebulized human umbilical cord mesenchymal stem cell-derived exosomes suspension
Sponsors
Hainan Medical College First Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18–75 years (inclusive), any gender. 2.Must meet both criteria below: ? Clinical manifestations consistent with viral/bacterial infection AND ? =1 of the following laboratory confirmations: A. Positive viral nucleic acid test B. Positive viral antigen test C. Positive viral isolation/culture D. Convalescent-phase virus-specific IgG =4-fold rise vs. acute phase E. Pathogenic bacteria isolated from sputum/lower respiratory tract secretions; 3.Documented viral/bacterial infection with: • Pneumonia persisting >4 weeks without resolution • Concurrent features of: Airway fibroproliferation Alveolar exudate organization Granulation tissue formation; 4.HRCT findings consistent with organizing pneumonia (=1 pattern): • Round-shaped opacities • Peribronchovascular infiltration • Pleural band-like shadows; 5.Ability to comprehend and perform pulmonary function tests. 6.Willingness to provide written informed consent after understanding: • Trial objectives • Procedures • Potential discomforts; 7.Good compliance with: • Protocol-specified treatment • Scheduled follow-up evaluations;
Exclusion criteria
Exclusion criteria: 1.Previous treatment with stem cells or exosomes. 2.Intolerance to nebulized inhalation therapy. 3.History of allergic constitution or life-threatening drug allergies. 4.Pregnancy, planned pregnancy within the study period, or lactation. 5.Unwillingness of fertile male participants or women of childbearing potential to use effective contraception for 12 months from treatment initiation through follow-up completion. 6.History of malignancy within 5 years prior to screening or previous systemic anticancer therapy. 7.Active hepatitis B or C virus infection, or HIV infection. 8.History of organ transplantation or currently awaiting organ transplantation. 9.History of psychiatric disorders. 10.Major surgery within 8 weeks before enrollment (excluding diagnostic procedures) or planned surgery during the study period, or incomplete wound healing from previous surgery. 11.Any of the following pulmonary conditions: Bronchial asthma Active tuberculosis Pulmonary embolism Pneumothorax Pneumoconiosis Idiopathic pulmonary hypertension Bronchiolitis obliterans Other active pulmonary diseases; 12.Severe systemic diseases including: Myocardial infarction Unstable angina Cardiac insufficiency Liver cirrhosis Acute glomerulonephritis; 13.Participation in any other clinical trial within 3 months prior to screening. 14.Current participation in another clinical trial. 15.Poor compliance likely to compromise study completion. 16.Any condition that, in the investigator's judgment, may increase participant risk or interfere with trial results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lung ventilation function and lung diffusion function;Blood Routine Test;Infectious Disease Screening;Serologic Tumor Marker;6 minutes walking distance;Interleukin-6,Interleukin-;Urine Pregnancy Test;Urine Routine Test;Peripheral Blood Lymphocyte Subsets;Acute aggravating event;High resolution chest CT(HRCT);Blood Biochemistry Test;St. George's Respiratory Questionnaire, Lester Cough Questionnaire, mMRC dyspnea Scale;electrocardiogram; | — |
Countries
China
Contacts
Public ContactHuang Huaping
Hainan Medical College First Affiliated Hospital
Outcome results
None listed