Bronchiolitis Obliterans, Lung Transplantation
Conditions
Keywords
Mesenchymal stromal cells, Bronchiolitis obliterans, Lung transplant
Brief summary
The primary aim of this study is to establish the safety of infusions of Mesenchymal Stromal Cells (MSC) from related or unrelated Human Leukocyte Antigen (HLA) identical or HLA mismatched donors in the management of bronchiolitis obliterans syndrome after lung transplantation.
Interventions
OTHERMSC
mesenchymal stromal cells (MSC), aiming for 2 x 106 /kg cells recipient body weight, aiming for a frequency of twice weekly for two weeks
Sponsors
Cell and Tissue Therapies Western Australia
The Prince Charles Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients with single, bilateral or heart-lung allografts 2. Patients with bronchiolitis obliterans syndrome (BOS) grades 2 & 3 (defined and graded according to international criteria (Appendix 1)), with evidence of deterioration in allograft function (i.e. deteriorating FEV1 or worsening BOS grade) within the last 12 months. 3. Patients with BOS grade 1 and evidence of deterioration in allograft function (i.e. deteriorating FEV1 or worsening BOS grade) within the last 12 months and at least one of the following additional risk factors for subsequent death: * Single lung transplant * Rapid deterioration (\>20% fall in FEV1 in the previous 12 months) * A pre-transplant diagnosis of usual interstitial pneumonia (pulmonary fibrosis) or pulmonary hypertension
Exclusion criteria
1. Patients with active infection, acute allograft rejection, or airway anastomotic complications 2. Patients with \> 3 infective exacerbations of BOS in the last 12 months 3. Patients with a history of cytomegalovirus (CMV) pneumonitis 4. Patients with poor performance status and/or not expected to survive 3 months 5. Patients who are pregnant or breastfeeding 6. Patients with an allergy to beef products. 7. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish the safety of infusions of MSC from related or unrelated HLA identical or HLA mismatched donors in the management of bronchiolitis obliterans syndrome after lung transplantation. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| To document changes in lung function and 6 minute walk distance (6MWD) following infusion of MSC | 12 months |
| To document survival post MSC infusion | 12 months |
Countries
Australia
Outcome results
None listed