Trial of Bone-marrow Derived Mesenchymal Stromal Cells (MSC) for New Onset Chronic Lung Allograft Dysfunction (ASSIST-CLAD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02709343|
Recruitment Status : Recruiting
First Posted : March 16, 2016
Last Update Posted : October 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lung Allograft Dysfunction (CLAD)||Drug: Bone-marrow derived MSCs Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Phase 2 Randomised Controlled Trial of Bone-marrow Derived Mesenchymal Stromal Cells (MSC) for New Onset Chronic Lung Allograft Dysfunction (CLAD)|
|Actual Study Start Date :||April 21, 2017|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
Experimental: Bone-marrow derived MSCs
4 doses of Allogeneic bone-marrow derived MSCs (2x106 cells/kg) given intravenously twice weekly for 2 weeks
Drug: Bone-marrow derived MSCs
Allogeneic ex vivo expanded, bone marrow-derived mesenchymal stromal cells
Other Name: MSC
Placebo Comparator: Placebo
Placebo product manufactured to look like MSCs
Placebo product visually very similar to mesenchymal stromal cells
- Progression-free survival [ Time Frame: From baseline to week 54 ]Progression-free survival is a composite end-point of freedom from CLAD progression or death from any-cause. CLAD progression is defined as fall in FEV1 > 10% from the baseline (screening visit) FEV1 to the 12 month (week 54) visit.
- Time to fall in FEV1 > 10% [ Time Frame: From the baseline (screening) visit ]Defined as fall in FEV1 > 10% from the baseline (screening visit) FEV1
- Freedom from Bronchiolitis Obliterans Syndrome (BOS) grade 3 [ Time Frame: Week 54 ]BOS grade 3 is defined as FEV1 <50% of the best-post-transplant FEV1
- All cause mortality [ Time Frame: Week 54 ]
- CLAD-specific mortality [ Time Frame: Week 54 ]Defined as any death felt by the investigator to be at least partially related to CLAD.
- Freedom from acute rejection [ Time Frame: From baseline to week 54 ]Acute rejection defined as any biopsy proven episode of acute vascular (A1-A4) or airway (B1R or B2R) rejection.
- Freedom from the development of new donor specific anti-HLA antibodies [ Time Frame: From baseline to week 14 ]An anti-HLA antibody (any mean fluorescent intensity level) with specificity for a donor HLA type at 3 months which was not present prior to IMP treatment
- Freedom from CLAD progression [ Time Frame: From baseline to week 54 ]CLAD progression is defined as fall in FEV1 > 10% from the baseline (screening visit) FEV1 at 12 months.
- Rate of FEV1 decline [ Time Frame: From baseline to week 54 ]Rate of FEV1 decline is defined as the slope of the regression line for FEV1 between the screening visit and week 54
- Rate of FVC decline [ Time Frame: From baseline to week 54 ]Rate of FVC decline is defined as the slope of the regression line for FVC between the screening visit and week 54
- Change in 6-minute walk distance (6MWD) [ Time Frame: From baseline to week 54 ]Change in 6MWD is defined as the difference between the 6MWD at screening and the week 54 visit. Patients who have died by week 54 will receive a 6MWD of 0.
- Change in St George's Respiratory Questionnaire (SGRQ) Score [ Time Frame: From baseline to week 54 ]Change in SGRQ is defined as the difference between the total SGRQ at screening and the week 54 visit. Patients who have died by week 54 will receive a SGRQ of 0.
- Inpatient bed-days [ Time Frame: From baseline to week 54 ]This is defined as the aggregate of inpatient bed-days between the screening visit and week 54.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709343
|Contact: Daniel Chambers, MBBS MD||+61 7 3139 email@example.com|
|Australia, New South Wales|
|St Vincents Hospital||Recruiting|
|Sydney, New South Wales, Australia, 2010|
|Contact: Alan Glanville, MBBS MD 02 8382 3257 Allan.Glanville@svha.org.au|
|The Prince Charles Hospital||Not yet recruiting|
|Brisbane, Queensland, Australia, 4032|
|Contact: Daniel Chambers, MBBS MD +61 7 3139 4000 Daniel.Chambers@health.qld.gov.au|
|Australia, South Australia|
|Royal Adelaide Hospital||Not yet recruiting|
|Adelaide, South Australia, Australia, 5000|
|Contact: Chien-Li Holmes-Liew, MBBS FRACP +61 8 8222 4000 firstname.lastname@example.org|
|The Alfred Hospital||Recruiting|
|Melbourne, Victoria, Australia, 3000|
|Contact: Glen Westall, MBBS PhD +61 3 9076 2000 email@example.com|
|Australia, Western Australia|
|Fiona Stanley Hospital||Recruiting|
|Murdoch, Western Australia, Australia, 6150|
|Contact: Michael Musk, MBBS FRACP 08 6152 0860 firstname.lastname@example.org|
|Principal Investigator:||Daniel Chambers, MBBS MD||University of Queensland & The Prince Charles Hospital|