Study of Human Bone Marrow Mesenchymal Stem Cells in APAP (NCT06111846) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Human Bone Marrow Mesenchymal Stem Cells in APAP
China10 participantsStarted 2023-12-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 n…
What they're measuring
1
Alveolar-arterial difference in oxygen tension (A-aDO2)