The Study of Mesenchymal Stem Cells Treat Autoimmune Pulmonary Alveolar Proteinosis in Vitro

NCT ID: NCT05640687

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-04-06

Brief Summary

Autoimmune pulmonary alveolar proteinosis (aPAP) is a respiratory disease characterized by massive deposition of pulmonary surfactant in the alveoli, involving a variety of immune cells and factor disorders. However, there are certain limits in treatment at present. MSCs can improve the microenvironment in the alveoli by regulating immunity, thereby achieving a good therapeutic effect. The purpose of this study is to use the lavage fluid obtained after whole lung lavage with aPAP to isolate alveolar macrophages, and to use MSC to complete the verification of the efficacy of aPAP primary alveolar macrophages in vitro. A series of protocols including multi-factor detection, cell phenotype analysis and phagocytosis assay were used to evaluate the efficacy of MSCs on alveolar macrophages.

Conditions

Pulmonary Alveolar Proteinosis(PAP)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

aPAP

No interventions assigned to this group

healthy control

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Sign an informed consent form before any research-related activities;

2. No gender restrictions, age ≥18 years old, and ≤75 years old;

3. Patients who need to receive whole lung lavage due to the needs of the disease, and the patient agrees to perform whole lung lavage. The standards are as follows:

1. The diagnosis of aPAP is clear, and the anti-GM-CSF antibody in serum is greater than 5 μg/ml;

2. PaO2 <65 mmHg;

3. P(A-a)O2>40 mmHg;

4. Intrapulmonary shunt >10%-12%.

Exclusion Criteria

1. Suffering from multiple chronic respiratory diseases at the same time, including but not limited to chronic obstructive pulmonary disease, pulmonary fibrosis, and asthma;

2. Various malignant tumors or a history of malignant tumors;

3. Uncontrolled pulmonary or systemic infection;

4. Severe other systemic diseases: acute myocardial infarction, unstable angina pectoris, liver cirrhosis, acute glomerulonephritis, etc.;

5. Syphilis, HIV, HCV antibody positive;

6. Patients with coagulation disorders who cannot perform bronchoscopy, such as hemophilia, giant platelet syndrome, thrombocytopenia, etc.;

7. Severe renal impairment, serum creatinine > 1.5 times the upper limit of normal;

8. Liver disease or liver function damage: ALT, AST, total bilirubin > 2 times the upper limit of normal;

9. Have any coexisting medical conditions or diseases that the investigators judge may impair the development of this trial;

10. Social and mental disability, no legal capacity/limited capacity;

11. Refuse to sign the informed consent.

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role: lead

Responsible Party

ShiYue Li

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2020132

Identifier Type: -

Identifier Source: org_study_id