Status:
ACTIVE_NOT_RECRUITING
Study of Human Bone Marrow Mesenchymal Stem Cells in APAP
Lead Sponsor:
Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd.
Collaborating Sponsors:
The First Affiliated Hospital of Guangzhou Medical University
Conditions:
Autoimmune Pulmonary Alveolar Proteinosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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), wh...
Eligibility Criteria
Inclusion
- Male or female aged 18 years or older
- Patients diagnosed with aPAP by both CT and biopsy (TBLB, TBCB, or surgical lung biopsy) or bronchoalveolar perfusion (BAL) as well as GM-CSF autoantibodies in serum positive
- No remission was demonstrated by CT, pulmonary function test results,or blood gas analysis at least 2 times (at least 3 months apart) before enrollment
- At rest PaO2≤70 mmHg
- Fertile participants must receive effective medical contraception (for both male and female participants, up to one year after the last study dosing)
- Voluntary signed informed consent
Exclusion
- Diagnosed with hereditary PAP, secondary PAP, or another type of PAP
- Received whole lung lavage（WLL） therapy within 6 months before enrollment
- Received previous GM-CSF therapy within 6 months before enrollment
- Received other clinical trial treatment within 3 months before enrollment
- Participated in other stem cell studies within 1 year before enrollment
- Inflammatory disease or autoimmune disorder requiring treatment associated with significant immunosuppression (e.g. more than 10 mg/day systemic prednisolone)
- Active infection (viral, bacterial, fungal or mycobacterial), which may affect the assessment of efficacy in the trial
- History of malignant tumors
- Known allergic reactions to any of the ingredients in the study drug
- Participants who, in the opinion of the investigator, would aggravate any other serious pre-existing medical condition are not suitable for this trial
- Women who are known to be pregnant, breastfeeding, have a positive pregnancy test (which will be detected during the screening process), or plan to become pregnant during the trial
Key Trial Info
Start Date :
December 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06111846
Start Date
December 25 2023
End Date
August 30 2026
Last Update
March 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
JiuzhitangMakerBeijingCellTech
Beijing, Daxing, China, 100021