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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by The Prince Charles Hospital
Sponsor:
Collaborator:
Cell & Tissue Therapies Western Australia
Information provided by (Responsible Party):
Philip Lee, The Prince Charles Hospital
ClinicalTrials.gov Identifier:
NCT01175655
First received: June 25, 2010
Last updated: April 7, 2014
Last verified: April 2014
  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: 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 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To document changes in lung function and 6 minute walk distance (6MWD) following infusion of MSC [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To document survival post MSC infusion [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: February 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175655

Contacts
Contact: Daniel C Chambers, MB BS MRCP FRACP MD + 61 7 31394000 Daniel_Chambers@health.qld.gov.au
Contact: Peter MA Hopkins, MB BS FRACP + 61 7 31394000 Peter_Hopkins@health.qld.gov.au

Locations
Australia, Queensland
TPCH Recruiting
Brisbane, Queensland, Australia, 4032
Contact: Chambers       Daniel_Chambers@health.qld.gov.au   
Australia, Western Australia
RPH Recruiting
Perth, Western Australia, Australia, 6000
Contact: Musk       Michael.musk@health.wa.gov.au   
Principal Investigator: Michael Musk         
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

No publications provided

Responsible Party: Philip Lee, Principal Investigator, The Prince Charles Hospital
ClinicalTrials.gov Identifier: NCT01175655     History of Changes
Other Study ID Numbers: EC 28105
Study First Received: June 25, 2010
Last Updated: April 7, 2014
Health Authority: Australia: Therapeutic Goods Administration

Keywords provided by The Prince Charles Hospital:
Mesenchymal stromal cells
Bronchiolitis obliterans
Lung transplantation

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

ClinicalTrials.gov processed this record on September 16, 2014