RecruitingPhase 2ACTRN12616000338460

Phase 2 Randomised controlled trial of bone-marrow derived mesenchymal stromal cells (MSC) for new onset chronic lung allograft dysfunction (CLAD)


Sponsor

University of Queensland

Enrollment

82 participants

Start Date

Apr 21, 2017

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether infusions of special stem cells called mesenchymal stromal cells (MSC) can slow or stop a serious lung condition called chronic lung allograft dysfunction (CLAD) in people who have had a lung transplant. CLAD causes the transplanted lungs to gradually stop working, and there is currently no reliable treatment. Participants receive four infusions over two weeks and are followed for a year to monitor lung function. You may be eligible if: - You are 18 years of age or older and have had a bilateral (two-lung) transplant at least 6 months ago - You have recently developed CLAD (a persistent drop in lung function of 20% or more in the past 12 months) - Other causes of lung function decline (like infection or rejection) have been ruled out - Your immunosuppression medications have been stable for 4 weeks - You are available for all required study visits and procedures, including bronchoscopies You may NOT be eligible if: - You have an untreated rejection or active infection - You have received certain treatments (macrolide antibiotics, IV steroids, photopheresis, or radiation) in the past 4 weeks - You are pregnant or breastfeeding - You are allergic to beef products - You are enrolled in another interventional clinical trial Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a 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

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)

The Prince Charles Hospital - Chermside

NSW,QLD,SA,WA,VIC, Australia

St Vincent's Hospital (Darlinghurst) - Darlinghurst

NSW,QLD,SA,WA,VIC, Australia

Fiona Stanley Hospital - Murdoch

NSW,QLD,SA,WA,VIC, Australia

The Alfred - Prahran

NSW,QLD,SA,WA,VIC, Australia

The Royal Adelaide Hospital - Adelaide

NSW,QLD,SA,WA,VIC, Australia

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ACTRN12616000338460