Clinical Research Directory

Inclusion Criteria: 1. Male or female participants aged ≥18 years; 2. Patients with pulmonary alveolar proteinosis (PAP) confirmed by imaging, bronchoalveolar lavage (BAL) cytology, or lung biopsy, including transbronchial lung biopsy (TBLB), transbronchial cryobiopsy (TBCB), or surgical lung biopsy, and who are positive for serum anti-GM-CSF antibodies; 3. At rest and while breathing room air, arterial partial pressure of oxygen (PaO₂) \>50 mmHg, and either PaO₂ ≤70 mmHg or an oxygenation index corrected for the fraction of inspired oxygen (PaO₂/FiO₂ ratio) ≤333 mmHg; or, in participants with symptoms such as cough, sputum production, and exertional dyspnea, PaO₂ \<75 mmHg or a PaO₂/FiO₂ ratio ≤357 mmHg; 4. At least two assessments, performed at an interval of ≥2 months, indicating no significant spontaneous improvement of the disease, defined as an improvement in \[A-a\]DO₂ of \<10 mmHg and an improvement in DLCO % predicted of \<10%. If only one of these criteria is met, the investigator shall determine, based on the participant's symptoms, oxygen therapy requirements, imaging findings, and previous treatments, whether the disease is in a stable, non-remitting or progressive state, and shall document the basis for this determination; 5. Participants of childbearing potential must use effective medically accepted contraceptive methods, regardless of sex, until 1 year after the last study treatment administration; 6. Voluntary provision of written informed consent. Exclusion Criteria: 1. Patients diagnosed with hereditary, secondary, or other types of PAP; 2. Patients who received whole-lung lavage (WLL) or granulocyte-macrophage colony-stimulating factor (GM-CSF) therapy within 3 months prior to screening; 3. Patients who received treatment as part of another clinical study within 3 months prior to screening; 4. Patients who participated in another clinical study involving stem cell therapy within 1 year prior to screening; 5. Patients with inflammatory or autoimmune diseases requiring concomitant treatment with immunosuppressive agents, such as prednisolone \>10 mg/day; 6. Patients with a history of infection requiring systemic antibiotics, antifungal agents, or antiviral agents; active infections (viral, bacterial, fungal, or mycobacterial); or other diseases that may interfere with the assessment of efficacy in the study; 7. History of malignancy; 8. Known hypersensitivity or allergic reaction to any component of the investigational product; 9. Participants who, in the investigator's judgment, are unsuitable for participation in the study, or who have any condition that, in the investigator's opinion, may increase the participant's risk or interfere with the conduct or assessment of the clinical trial; 10. Female participants who are pregnant or breastfeeding, female participants planning to become pregnant, or male or female participants who intend to have children within 3 months after completion of the study.