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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02709343




Registration number
NCT02709343
Ethics application status
Date submitted
1/03/2016
Date registered
16/03/2016

Titles & IDs
Public title
Trial of Bone-marrow Derived Mesenchymal Stromal Cells (MSC) for New Onset Chronic Lung Allograft Dysfunction
Scientific title
Phase 2 Randomised Controlled Trial of Bone-marrow Derived Mesenchymal Stromal Cells (MSC) for New Onset Chronic Lung Allograft Dysfunction (CLAD)
Secondary ID [1] 0 0
ASSIST-CLAD
Universal Trial Number (UTN)
Trial acronym
ASSIST-CLAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lung Allograft Dysfunction (CLAD) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bone-marrow derived MSCs
Treatment: Drugs - Placebo

Experimental: Bone-marrow derived MSCs - 4 doses of Allogeneic bone-marrow derived MSCs (2x106 cells/kg) given intravenously twice weekly for 2 weeks

Placebo comparator: Placebo - Placebo product manufactured to look like MSCs


Treatment: Drugs: Bone-marrow derived MSCs
Allogeneic ex vivo expanded, bone marrow-derived mesenchymal stromal cells

Treatment: Drugs: Placebo
Placebo product visually very similar to mesenchymal stromal cells
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival
Timepoint [1] 0 0
From baseline to week 54
Secondary outcome [1] 0 0
Time to fall in FEV1 > 10%
Timepoint [1] 0 0
From the baseline (screening) visit
Secondary outcome [2] 0 0
Freedom from Bronchiolitis Obliterans Syndrome (BOS) grade 3
Timepoint [2] 0 0
Week 54
Secondary outcome [3] 0 0
All cause mortality
Timepoint [3] 0 0
Week 54
Secondary outcome [4] 0 0
CLAD-specific mortality
Timepoint [4] 0 0
Week 54
Secondary outcome [5] 0 0
Freedom from acute rejection
Timepoint [5] 0 0
From baseline to week 54
Secondary outcome [6] 0 0
Freedom from the development of new donor specific anti-HLA antibodies
Timepoint [6] 0 0
From baseline to week 14
Secondary outcome [7] 0 0
Freedom from CLAD progression
Timepoint [7] 0 0
From baseline to week 54
Secondary outcome [8] 0 0
Rate of FEV1 decline
Timepoint [8] 0 0
From baseline to week 54
Secondary outcome [9] 0 0
Rate of FVC decline
Timepoint [9] 0 0
From baseline to week 54
Secondary outcome [10] 0 0
Change in 6-minute walk distance (6MWD)
Timepoint [10] 0 0
From baseline to week 54
Secondary outcome [11] 0 0
Change in St George's Respiratory Questionnaire (SGRQ) Score
Timepoint [11] 0 0
From baseline to week 54
Secondary outcome [12] 0 0
Inpatient bed-days
Timepoint [12] 0 0
From baseline to week 54

Eligibility
Key inclusion criteria
1. Bilateral lung transplant recipients aged = 18 years and at least 6 months post-transplant. Patients with other organs transplanted (eg heart, liver, kidney) or those who have undergone lobar transplantation, or re-transplantation, are potentially eligible.
2. New-onset CLAD (defined as a persistent (3weeks apart) fall in FEV1 of at least 20% from the mean of the two best post-transplant values taken at least 3 weeks apart) in the 12 months prior to the screening visit. Other causes of a fall in FEV1 (acute cellular or humoral rejection, active infection, anastomotic stenosis etc.) must be excluded as per international guidelines.
3. Stable immunosuppression regimen, as assessed by the investigator, in the 8 weeks prior to the screening visit.
4. Available for all specified assessments at the study site through the completion of the study, including the protocol bronchoscopies.
5. Provision of written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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
2. Untreated cellular or humoral rejection
3. Clinically meaningful and untreated viral, bacterial or fungal infection
4. Use of azithromycin or another macrolide antibiotic, if commenced within 8 weeks of the screening visit
5. Intravenous pulsed methylprednisolone, within 4 weeks of the screening visit
6. Use of extracorporeal photopheresis, within 4 weeks of the screening visit
7. Use of total lymphoid irradiation, within 4 weeks of the screening visit
8. Poor functional status not expected to survive 6 months
9. Allergy to beef products
10. Women who are pregnant, breast-feeding or unwilling to use adequate contraception
11. Patients who are currently participating in another interventional clinical trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
21/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/10/2023
Sample size
Target
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
St Vincents Hospital - Sydney
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
4032 - Brisbane
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
6150 - Murdoch

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Isopogen
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Cell and Tissue Therapies
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniel Chambers, MBBS MD
Address 0 0
University of Queensland & 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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data will be analysed and shared with collaborators with the plan to publish the results.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02709343