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
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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