Phase 2 Randomised controlled trial of bone-marrow derived mesenchymal stromal cells (MSC) for new onset chronic lung allograft dysfunction (CLAD)
University of Queensland
82 participants
Apr 21, 2017
Interventional
Conditions
Summary
This is a phase 2 multi centre randomised study where consented Lung transplant patients that have met the criteria for new onset CLAD (and none of the exclusion criteria) will receive 4 doses of Mesenchymal Stromal Cells (MSC)/placebo intravenous infusions over a period of 2 weeks. Follow up review will be performed at weeks 3,6,10,14,28,41 and 54. It is hypothesied that MSC treatment will result in a progression free survival of patients with new-onset CLAD experiencing disease progression at 12 months.
Eligibility
Inclusion Criteria5
- Bilateral lung transplant recipients aged greater or equal to 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 4 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 Criteria11
- 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 4 weeks of the screening visit
- Intravenous pulsed methylprednisolone, within 4 weeks of the screening visit
- Use of extracorporeal photopheresis, within 4 weeks of the screening visit
- Use of total lymphoid irradiation, within 4 weeks of the screening visit
- Poor functional status not expected to survive 6 months
- Allergy to beef products
- Women who are pregnant, breast-feeding or unwilling to use adequate contraception
- Patients who are currently participating in another interventional clinical trial
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Interventions
Eligible lung transplant patients diagnosed with new onset of CLAD will receive 4 infusions of allogenic bone - marrow derived Mesenchymal stromal cells (MSC) or 4 infusions of placebo within 2 weeks (at the clinical discretion of the treating physician) with a 12 month follow up period. The MSC/placebo dose is 2 x 10 6 cells/kg administered intravenously twice a week for 2 weeks. Allogenic ex vivo expanded, bone marrow derived MSC are produced by Cell and Tissue Therapies in Western Australia from a adult human healthy donor. MSCs are tested for possible infectious agents such as viruses or bacteria at several time points within the manufacturing of the MSC product.
Locations(5)
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ACTRN12616000338460