NCT01175655CompletedPhase 1
A Study to Evaluate the Potential of Mesenchymal Stromal Cells to Treat Obliterative Bronchiolitis After Lung Transplantation
The Prince Charles Hospital4 sites in 1 country10 target enrollmentStarted: February 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- The Prince Charles Hospital
- Enrollment
- 10
- Locations
- 4
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with single, bilateral or heart-lung allografts
- •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.
- •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
- •Patients with active infection, acute allograft rejection, or airway anastomotic complications
- •Patients with > 3 infective exacerbations of BOS in the last 12 months
- •Patients with a history of cytomegalovirus (CMV) pneumonitis
- •Patients with poor performance status and/or not expected to survive 3 months
- •Patients who are pregnant or breastfeeding
- •Patients with an allergy to beef products.
- •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.
Outcomes
Primary Outcomes
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.
Time Frame: 12 months
Secondary Outcomes
- 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)
Investigators
Daniel Chambers
Principal Investigator
The Prince Charles Hospital
Study Sites (4)
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