None listed
Conditions
Brief 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.
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
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.
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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. 3. Stable immunosuppression regimen, as assessed by the investigator, in the 4 weeks prior to the screening visit. 4. Available for all specified assessments at the study site through the completion of the study, including the protocol bronchoscopies. 6. Provision of written informed consent.
Exclusion criteria
1. 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 2. Untreated cellular or humoral rejection 3. Clinically meaningful and untreated viral, bacterial or fungal infection 4. Use of azithromycin or another macrolide antibiotic, if commenced within 4 weeks of the screening visit 5. Intravenous pulsed methylprednisolone, within 4 weeks of the screening visit 6. Use of extracorporeal photopheresis, within 4 weeks of the screening visit 7. Use of total lymphoid irradiation, within 4 weeks of the screening visit 8. Poor functional status not expected to survive 6 months 10. Allergy to beef products 11. Women who are pregnant, breast-feeding or unwilling to use adequate contraception 12. Patients who are currently participating in another interventional clinical trial
Outcome results
None listed