Clincosm LogoSign in Get a demo

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

Sponsor
Guangzhou Institute of Respiratory Disease (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05640687
Collaborator
(none)
26
Enrollment
1
Location
24.1
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    26 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Study of Mesenchymal Stem Cells Treat Autoimmune Pulmonary Alveolar in Vitro
    Actual Study Start Date :
    Mar 1, 2021
    Anticipated Primary Completion Date :
    Feb 1, 2023
    Anticipated Study Completion Date :
    Mar 6, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    aPAP
    healthy control

    Outcome Measures

    Primary Outcome Measures

    1. Genomics [2022.12.31-2023.03.01]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

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

    5. PaO2 <65 mmHg;

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

    7. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong China 510120

    Sponsors and Collaborators

    • Guangzhou Institute of Respiratory Disease

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ShiYue Li, Professor, Guangzhou Institute of Respiratory Disease
    ClinicalTrials.gov Identifier:
    NCT05640687
    Other Study ID Numbers:
    • 2020132
    First Posted:
    Dec 7, 2022
    Last Update Posted:
    Dec 7, 2022
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by ShiYue Li, Professor, Guangzhou Institute of Respiratory Disease
    aPAP
    cell therapy
    MSC
    Additional relevant MeSH terms:
    Pulmonary Alveolar Proteinosis

    Study Results

    No Results Posted as of Dec 7, 2022