A Study to Evaluate the Potential of Mesenchymal Stromal Cells to Treat Obliterative Bronchiolitis After Lung Transplantation

The Prince Charles Hospital2 sites in 1 country10 target enrollmentFebruary 2010

ConditionsBronchiolitis Obliterans Lung Transplantation

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Bronchiolitis Obliterans
Sponsor: The Prince Charles Hospital
Enrollment: 10
Locations: 2
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.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

July 2016

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The Prince Charles Hospital

Responsible Party

Principal Investigator

Daniel Chambers

Principal Investigator

The Prince Charles Hospital

Eligibility Criteria

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)