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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Alveolar Proteinosis(PAP)

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This project recruited clinical patients who met the criteria for inclusion and exclusion from patients diagnosed with aPAP in the First Affiliated Hospital of Guangzhou Medical University.

Description

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.

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Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
aPAP
healthy control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Genomics	2022.12.31-2023.03.01

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): February 1, 2023
• Study Completion (Anticipated): April 6, 2023

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: cell therapy; MSC; aPAP
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Alveolar Proteinosis
• Other Study ID Numbers: 2020132

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No