NCT06111846

Study of Human Bone Marrow Mesenchymal Stem Cells in APAP

An Open-label Phase IIa Study to Evaluate the Safety and Preliminary Efficacy of HBMMSC Injection in the Treatment of APAP

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this open-label phase IIa clinical trial study is to evaluate the safety and preliminary efficacy of hBMMSC intravenous treatment in patients with aPAP.

Detailed description

Autoimmune pulmonary alveolar proteinosis (aPAP) is a rare lung disease for which there is no specific drug treatment. Currently, the standard treatment strategy for PAP is whole-lung lavage (WLL), which is invasive and has limited therapeutic efficacy. The purpose of this study is to evaluate the safety and preliminary efficacy of hBMMSC intravenous treatment in patients with aPAP. The clinical trial intends to involve 10 participants. The trial is expected to last approximately 2 years.

Conditions

• Autoimmune Pulmonary Alveolar Proteinosis

Interventions

Type	Name	Description
DRUG	human Bone Marrow Mesenchymal Stem Cell (hBMMSC)	Group 1: 1.0×10\^6 cells/kg (participant's body weight) single dose (n=3) Group 2: 2.0×10\^6 cells/kg (participant's body weight) single dose (n=3) Group 3: 2.0×10\^6 cells/kg (participant's body weight) administered twice (n=4)

Timeline

• Start date: 2023-12-25
• Primary completion: 2025-07-22
• Completion: 2026-08-30
• First posted: 2023-11-01
• Last updated: 2025-03-24

Locations

1 site across 1 country: China