Trial of Bone-marrow Derived Mesenchymal Stromal Cells (MSC) for New Onset Chronic Lung Allograft… (NCT02709343) | Clinical Trial Compass
CompletedPhase 2
Trial of Bone-marrow Derived Mesenchymal Stromal Cells (MSC) for New Onset Chronic Lung Allograft Dysfunction
Australia64 participantsStarted 2017-04-21
Plain-language summary
This study is designed for lung transplant patients who have developed chronic lung allograft dysfunction (CLAD). Consented patients will receive 4 intravenous doses of allogeneic, bone-marrow-derived MSCs (2\*10\^6 cells/kg/dose) or matching placebo over a period of 2 weeks with a 12 month follow up.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Bilateral lung transplant recipients aged ≥ 18 years and at least 6 months post-transplant. Patients with other organs transplanted (eg heart, liver, kidney) or those who have undergone lobar transplantation, or re-transplantation, are potentially eligible.
✓. New-onset CLAD (defined as a persistent (3weeks apart) fall in FEV1 of at least 20% from the mean of the two best post-transplant values taken at least 3 weeks apart) in the 12 months prior to the screening visit. Other causes of a fall in FEV1 (acute cellular or humoral rejection, active infection, anastomotic stenosis etc.) must be excluded as per international guidelines.
✓. Stable immunosuppression regimen, as assessed by the investigator, in the 8 weeks prior to the screening visit.
✓. Available for all specified assessments at the study site through the completion of the study, including the protocol bronchoscopies.
✓. Provision of written informed consent.
Exclusion criteria
✕. Any condition that in the opinion of the Investigator may interfere with the safety of the patient, his / her completion of required follow-up visits or evaluation of the study objectives
✕. Untreated cellular or humoral rejection
✕. Clinically meaningful and untreated viral, bacterial or fungal infection
✕. Use of azithromycin or another macrolide antibiotic, if commenced within 8 weeks of the screening visit
✕. Intravenous pulsed methylprednisolone, within 4 weeks of the screening visit