A Study to Evaluate the Potential of Mesenchymal Stromal Cells to Treat Obliterative Bronchiolitis After Lung Transplantation (MSC in OB)
This study is ongoing, but not recruiting participants.
Cell & Tissue Therapies Western Australia
Information provided by (Responsible Party):
Daniel Chambers, The Prince Charles Hospital
First received: June 25, 2010
Last updated: April 30, 2015
Last verified: April 2015
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.
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Study to Evaluate the Potential of Mesenchymal Stromal Cells to Treat Obliterative Bronchiolitis After Lung Transplantation
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To document changes in lung function and 6 minute walk distance (6MWD) following infusion of MSC [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- To document survival post MSC infusion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2016 (Final data collection date for primary outcome measure)
mesenchymal stromal cells (MSC), aiming for 2 x 106 /kg cells recipient body weight, aiming for a frequency of twice weekly for two weeks
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01175655
|Brisbane, Queensland, Australia, 4032 |
|Perth, Western Australia, Australia, 6000 |
The Prince Charles Hospital
Cell & Tissue Therapies Western Australia
||Daniel Chambers, A/Prof
||The Prince Charles Hospital
No publications provided
||Daniel Chambers, Principal Investigator, The Prince Charles Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 25, 2010
||April 30, 2015
||Australia: Therapeutic Goods Administration
Keywords provided by The Prince Charles Hospital:
Mesenchymal stromal cells
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 31, 2015
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections