- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01175655
A Study to Evaluate the Potential of Mesenchymal Stromal Cells to Treat Obliterative Bronchiolitis After Lung Transplantation (MSC in OB)
April 19, 2022 updated by: Daniel Chambers, The Prince Charles Hospital
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Queensland
-
Brisbane, Queensland, Australia, 4032
- TPCH
-
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Western Australia
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Perth, Western Australia, Australia, 6000
- RPH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To document changes in lung function and 6 minute walk distance (6MWD) following infusion of MSC
Time Frame: 12 months
|
12 months
|
To document survival post MSC infusion
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniel Chambers, A/Prof, The Prince Charles Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (ACTUAL)
July 1, 2015
Study Completion (ACTUAL)
July 1, 2016
Study Registration Dates
First Submitted
June 25, 2010
First Submitted That Met QC Criteria
August 4, 2010
First Posted (ESTIMATE)
August 5, 2010
Study Record Updates
Last Update Posted (ACTUAL)
April 26, 2022
Last Update Submitted That Met QC Criteria
April 19, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC 28105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bronchiolitis Obliterans
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University Hospital, Basel, SwitzerlandRecruitingBronchiolitis Obliterans Syndrome (BOS) | Bronchiolitis Obliterans (BO)Switzerland, Saudi Arabia
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Washington University School of MedicineThe Foundation for Barnes-Jewish Hospital; Mallinckrodt; Centers for Medicare...Active, not recruitingBronchiolitis Obliterans Syndrome (BOS)United States
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Renovion, Inc.RecruitingPre-Bronchiolitis Obliterans SyndromeUnited States
-
Children's Hospital Medical Center, CincinnatiRecruitingBronchiolitis Obliterans (BO) | Hematopoietic Stem Cell Transplant (HSCT)United States
-
University of ChicagoCompletedBronchiolitis Obliterans SyndromeUnited States
-
Zambon SpATerminatedStem Cell Transplant Complications | GVHD, Chronic | Bronchiolitis Obliterans Syndrome (BOS)Spain, France, Germany
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University Hospital RegensburgClinAssess GmbHUnknownSteroid-refractory Bronchiolitis ObliteransGermany
-
KU LeuvenUniversity Hospital, Gasthuisberg; Fund for Scientific Research, Flanders,...CompletedGraft Rejection | Respiratory Infection | Bronchiolitis Obliterans Syndrome | Lymphocytic BronchiolitisBelgium
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The Hospital for Sick ChildrenRecruitingBronchiolitis Obliterans SyndromeCanada
-
Hopital FochCompletedBronchiolitis Obliterans SyndromeFrance
Clinical Trials on MSC
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Hadassah Medical OrganizationCompleted
-
Fu-Sheng WangUnknownHuman Immunodeficiency Virus | Disorder of Immune ReconstitutionChina
-
National Heart, Lung, and Blood Institute (NHLBI)TerminatedGraft-Versus-Host DiseaseUnited States
-
King Edward Medical UniversityUnknownSkin Pigmentation Over Contour Deformities of Face | Trauma, Rhomberg DiseasePakistan
-
Indonesia UniversityUnknownNon Union Fracture | Metaphyseal Fibrous DefectIndonesia
-
Affiliated Hospital to Academy of Military Medical...UnknownAcute GVH DiseaseChina
-
University of Wisconsin, MadisonNational Institute of Dental and Craniofacial Research (NIDCR)RecruitingHead and Neck Cancer | XerostomiaUnited States
-
University Hospital TuebingenNot yet recruiting
-
Nanjing Medical UniversityUnknown
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Sixth Affiliated Hospital, Sun Yat-sen UniversityUnknownFistula | Crohn's Disease