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NCT07890649
A Study of hBMMSC Injection in Patients With aPAP
Conditions: Autoimmune Pulmonary Alveolar Proteinosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 70
Sponsor: Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd.
Location: The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong
Summary
The purpose of this multicenter, randomized, double-blind, placebo-controlled phase IIb clinical trial is to evaluate the efficacy and safety of intravenous hBMMSC injection in patients with autoimmune pulmonary alveolar proteinosis (aPAP).
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07890649). StuddyBuddy aggregates publicly available trial information.
