The Study of Mesenchymal Stem Cells Treat Autoimmune Pulmonary Alveolar Proteinosis in Vitro (NCT05640687) | Clinical Trial Compass
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The Study of Mesenchymal Stem Cells Treat Autoimmune Pulmonary Alveolar Proteinosis in Vitro
China26 participantsStarted 2021-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Sign an informed consent form before any research-related activities;
. No gender restrictions, age ≥18 years old, and ≤75 years old;
. 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:
. The diagnosis of aPAP is clear, and the anti-GM-CSF antibody in serum is greater than 5 μg/ml;
. PaO2 \<65 mmHg;
. P(A-a)O2\>40 mmHg;
. Intrapulmonary shunt \>10%-12%.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Suffering from multiple chronic respiratory diseases at the same time, including but not limited to chronic obstructive pulmonary disease, pulmonary fibrosis, and asthma;
. Various malignant tumors or a history of malignant tumors;
. Uncontrolled pulmonary or systemic infection;
. Severe other systemic diseases: acute myocardial infarction, unstable angina pectoris, liver cirrhosis, acute glomerulonephritis, etc.;
. Syphilis, HIV, HCV antibody positive;
. Patients with coagulation disorders who cannot perform bronchoscopy, such as hemophilia, giant platelet syndrome, thrombocytopenia, etc.;
. Severe renal impairment, serum creatinine \> 1.5 times the upper limit of normal;
. Liver disease or liver function damage: ALT, AST, total bilirubin \> 2 times the upper limit of normal;