Bronchiolitis ObliteransPhase 1MSC in OBNCT01175655
A Study to Evaluate the Potential of Mesenchymal Stromal Cells to Treat Obliterative Bronchiolitis After Lung Transplantation
A Phase 1 study testing MSC in people with Bronchiolitis Obliterans and Lung Transplantation, run by The Prince Charles Hospital at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bronchiolitis Obliterans, Lung Transplantation
- What is being tested?
- MSC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesAustralia
- Study dates
- Feb 2010to Jul 2016
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
TPCH
Brisbane, Queensland, 4032
RPH
Perth, Western Australia, 6000
About this study
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.
- Conditions
- Bronchiolitis Obliterans, Lung Transplantation
- Being tested
- MSC
- Keywords
- Mesenchymal stromal cells, Bronchiolitis obliterans, Lung transplant
- Medical subject headings
- Bronchiolitis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCOther
mesenchymal stromal cells (MSC), aiming for 2 x 106 /kg cells recipient body weight, aiming for a frequency of twice weekly for two weeks
| Study group | Role | What they receive |
|---|---|---|
| MSC | Experimental | Not described Receives: Other: MSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
To document changes in lung function and 6 minute walk distance (6MWD) following infusion of MSC
Measured: 12 months
To document survival post MSC infusion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis ObliteransStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Prince Charles Hospital
- Sponsor type
- Other government
- Collaborators
- Cell and Tissue Therapies Western Australia
- Responsible party
- Principal investigator, Daniel Chambers, The Prince Charles Hospital
- Investigators
- Daniel Chambers, A/Prof, Principal investigator, The Prince Charles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175655
- Sponsor's protocol ID
- EC 28105
- Acronym
- MSC in OB
- Status last verified
- Apr 2022
- First submitted
- 25 Jun 2010
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Potential of Mesenchymal Stromal Cells to Treat Obliterative Bronchiolitis After Lung Transplantation
- ClinicalTrials.gov ID
- NCT01175655
- Acronym / sponsor ID
- MSC in OB / EC 28105
- Conditions
- Bronchiolitis Obliterans, Lung Transplantation
- Keywords
- Mesenchymal stromal cells, Bronchiolitis obliterans, Lung transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Prince Charles HospitalOther government
- Collaborators
- Cell and Tissue Therapies Western Australia
- Study start
- Feb 2010
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 5 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSC | Experimental | Other: MSC |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSCmesenchymal stromal cells (MSC), aiming for 2 x 106 /kg cells recipient body weight, aiming for a frequency of twice weekly for two weeks | Other | MSC |
Primary outcome
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
2 secondary outcomes
To document changes in lung function and 6 minute walk distance (6MWD) following infusion of MSC
Time frame: 12 months
To document survival post MSC infusion
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Chambers, A/Prof principal investigator
The Prince Charles Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MSC in people with Bronchiolitis Obliterans and Lung Transplantation, run by The Prince Charles Hospital at 2 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 6 inclusion and 7 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 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2022.