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A Study to Evaluate the Potential of Mesenchymal Stromal Cells to Treat Obliterative Bronchiolitis After Lung Transplantation (MSC in OB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01175655
First Posted: August 5, 2010
Last Update Posted: October 11, 2016
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. Read our disclaimer for details.
Collaborator:
Cell & Tissue Therapies Western Australia
Information provided by (Responsible Party):
Daniel Chambers, The Prince Charles Hospital
  Purpose
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.

Condition Intervention Phase
Bronchiolitis Obliterans Lung Transplantation Other: MSC Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Potential of Mesenchymal Stromal Cells to Treat Obliterative Bronchiolitis After Lung Transplantation

Resource links provided by NLM:


Further study details as provided by Daniel Chambers, The Prince Charles Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: February 2010
Study Completion Date: July 2016
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MSC Other: 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

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with single, bilateral or heart-lung allografts
  2. 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.
  3. 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:

  1. Patients with active infection, acute allograft rejection, or airway anastomotic complications
  2. Patients with > 3 infective exacerbations of BOS in the last 12 months
  3. Patients with a history of cytomegalovirus (CMV) pneumonitis
  4. Patients with poor performance status and/or not expected to survive 3 months
  5. Patients who are pregnant or breastfeeding
  6. Patients with an allergy to beef products.
  7. 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.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01175655


Locations
Australia, Queensland
TPCH
Brisbane, Queensland, Australia, 4032
Australia, Western Australia
RPH
Perth, Western Australia, Australia, 6000
Sponsors and Collaborators
The Prince Charles Hospital
Cell & Tissue Therapies Western Australia
Investigators
Principal Investigator: Daniel Chambers, A/Prof The Prince Charles Hospital
  More Information

Responsible Party: Daniel Chambers, Principal Investigator, The Prince Charles Hospital
ClinicalTrials.gov Identifier: NCT01175655     History of Changes
Other Study ID Numbers: EC 28105
First Submitted: June 25, 2010
First Posted: August 5, 2010
Last Update Posted: October 11, 2016
Last Verified: October 2016

Keywords provided by Daniel Chambers, The Prince Charles Hospital:
Mesenchymal stromal cells
Bronchiolitis obliterans
Lung transplant

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis Obliterans
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections