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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01175655




Registration number
NCT01175655
Ethics application status
Date submitted
25/06/2010
Date registered
5/08/2010
Date last updated
26/04/2022

Titles & IDs
Public title
A Study to Evaluate the Potential of Mesenchymal Stromal Cells to Treat Obliterative Bronchiolitis After Lung Transplantation
Scientific title
A Study to Evaluate the Potential of Mesenchymal Stromal Cells to Treat Obliterative Bronchiolitis After Lung Transplantation
Secondary ID [1] 0 0
EC 28105
Universal Trial Number (UTN)
Trial acronym
MSC in OB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiolitis Obliterans 0 0
Lung Transplantation 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - MSC

Experimental: MSC -


Other interventions: MSC
mesenchymal stromal cells (MSC), aiming for 2 x 106 /kg cells recipient body weight, aiming for a frequency of twice weekly for two weeks
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
To document changes in lung function and 6 minute walk distance (6MWD) following infusion of MSC
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
To document survival post MSC infusion
Timepoint [2] 0 0
12 months

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2016
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 0 0
TPCH - Brisbane
Recruitment hospital [2] 0 0
RPH - Perth
Recruitment postcode(s) [1] 0 0
4032 - Brisbane
Recruitment postcode(s) [2] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
The Prince Charles Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cell and Tissue Therapies Western Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01175655
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniel Chambers, A/Prof
Address 0 0
The Prince Charles Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01175655