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Chronic Lung Allograft Dysfunction (CLAD)Phase 2ASSIST-CLADNCT02709343

Trial of Bone-marrow Derived Mesenchymal Stromal Cells (MSC) for New Onset Chronic Lung Allograft Dysfunction

A Phase 2 study testing Bone-marrow derived MSCs in people with Chronic Lung Allograft Dysfunction (CLAD), run by The University of Queensland at 5 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed for lung transplant patients who have developed chronic lung allograft dysfunction (CLAD). Consented patients will receive 4 intravenous doses of allogeneic, bone-marrow-derived MSCs (2*10^6 cells/kg/dose) or matching placebo over a period of 2 weeks with a 12 month follow up. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bone-marrow derived MSCs
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
5 sitesAustralia
Study dates
21 Apr 2017to 25 Oct 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • Stable immunosuppression regimen, as assessed by the investigator, in the 8 weeks prior to the screening visit.
  • Available for all specified assessments at the study site through the completion of the study, including the protocol bronchoscopies.
  • Provision of written informed consent.

Who cannot join

  • 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
  • Untreated cellular or humoral rejection
  • Clinically meaningful and untreated viral, bacterial or fungal infection
  • Use of azithromycin or another macrolide antibiotic, if commenced within 8 weeks of the screening visit
  • Intravenous pulsed methylprednisolone, within 4 weeks of the screening visit
  • Use of extracorporeal photopheresis, within 4 weeks of the screening visit
Show all 11Show fewer
  • Use of total lymphoid irradiation, within 4 weeks of the screening visit
  • Poor functional status not expected to survive 6 months
  • Allergy to beef products
  • Women who are pregnant, breast-feeding or unwilling to use adequate contraception
  • Patients who are currently participating in another interventional clinical trial

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • The Prince Charles Hospital

    Brisbane, Queensland, 4032

  • The Alfred Hospital

    Melbourne, Victoria, 3000

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • St Vincents Hospital

    Sydney, New South Wales, 2010

Other trials in Australia

About this study

Official title: Phase 2 Randomised Controlled Trial of Bone-marrow Derived Mesenchymal Stromal Cells (MSC) for New Onset Chronic Lung Allograft Dysfunction (CLAD)

This study is designed for lung transplant patients who have developed chronic lung allograft dysfunction (CLAD). Consented patients will receive 4 intravenous doses of allogeneic, bone-marrow-derived MSCs (2*10^6 cells/kg/dose) or matching placebo over a period of 2 weeks with a 12 month follow up.

Read the detailed description

This is a phase 2, multi-center, randomized study (n=82, 1:1 MSC:placebo) where consented patients will receive 4 intravenous doses of IMP over a period of 2 weeks. Patients must provide written informed consent and meet the all Inclusion Criteria and none of the Exclusion Criteria to be eligible. Screening procedures include obtaining medical history, current medications, questionnaires, vital signs, Chest Xray, 6 Minute walk test and blood tests. Historical chest CT and full lung function from 12 weeks prior to screening may be used. Bronchoscopy with biopsy must have been performed no more than 6 months prior to screening. A bronchoscopy with bronchoalveolar lavage (BAL) is required, however will not need to be repeated if performed within 14 days prior to the baseline visit. Patients will then receive 4 infusions of MSC/placebo over a period of 2 weeks, with follow up at Week 3,6,10,14,28,41 and week 54.

Being tested
Bone-marrow derived MSCs, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bone-marrow derived MSCsDrug

    Also called MSC

    Allogeneic ex vivo expanded, bone marrow-derived mesenchymal stromal cells

  • PlaceboDrug

    Placebo product visually very similar to mesenchymal stromal cells

Study groups in NCT02709343
Study groupRoleWhat they receive
Bone-marrow derived MSCsExperimental4 doses of Allogeneic bone-marrow derived MSCs (2x106 cells/kg) given intravenously twice weekly for 2 weeks
Receives: Drug: Bone-marrow derived MSCs
PlaceboPlacebo comparatorPlacebo product manufactured to look like MSCs
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    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.

    Measured: From baseline to week 54

Secondary outcomes (12)

  1. Time to fall in FEV1 > 10%

    Defined as fall in FEV1 > 10% from the baseline (screening visit) FEV1

    Measured: From the baseline (screening) visit

  2. Freedom from Bronchiolitis Obliterans Syndrome (BOS) grade 3

    BOS grade 3 is defined as FEV1 <50% of the best-post-transplant FEV1

    Measured: Week 54

  3. All cause mortality

    Measured: Week 54

  4. CLAD-specific mortality

    Defined as any death felt by the investigator to be at least partially related to CLAD.

    Measured: Week 54

  5. Freedom from acute rejection

    Acute rejection defined as any biopsy proven episode of acute vascular (A1-A4) or airway (B1R or B2R) rejection.

    Measured: From baseline to week 54

  6. Freedom from the development of new donor specific anti-HLA antibodies

    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

    Measured: From baseline to week 14

  7. Freedom from CLAD progression

    CLAD progression is defined as fall in FEV1 > 10% from the baseline (screening visit) FEV1 at 12 months.

    Measured: From baseline to week 54

  8. Rate of FEV1 decline

    Rate of FEV1 decline is defined as the slope of the regression line for FEV1 between the screening visit and week 54

    Measured: From baseline to week 54

  9. Rate of FVC decline

    Rate of FVC decline is defined as the slope of the regression line for FVC between the screening visit and week 54

    Measured: From baseline to week 54

  10. Change in 6-minute walk distance (6MWD)

    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.

    Measured: From baseline to week 54

  11. Change in St George's Respiratory Questionnaire (SGRQ) Score

    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.

    Measured: From baseline to week 54

  12. Inpatient bed-days

    This is defined as the aggregate of inpatient bed-days between the screening visit and week 54.

    Measured: From baseline to week 54

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2016 (estimated)
  2. Study start21 Apr 2017
  3. Primary completion13 Sep 2023
  4. Study completion25 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02709343
Sponsor's protocol ID
ASSIST-CLAD
Acronym
ASSIST-CLAD
Status last verified
Dec 2023
First submitted
1 Mar 2016
Last updated
6 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data will be analysed and shared with collaborators with the plan to publish the results.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bone-marrow derived MSCs in people with Chronic Lung Allograft Dysfunction (CLAD), run by The University of Queensland at 5 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: From baseline to week 54). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02709343.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.

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