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Completed

NCT Number: NCT01175655

A Study to Evaluate the Potential of Mesenchymal Stromal Cells to Treat Obliterative Bronchiolitis After Lung Transplantation

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.

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Key information

Conditions

Bronchiolitis Obliterans Bronchial Diseases Bronchiolitis Bronchitis Lung Diseases Lung Diseases, Obstructive Lung Transplantation Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

TPCH, Brisbane, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MSC

Other

mesenchymal stromal cells (MSC), aiming for 2 x 106 /kg cells recipient body weight, aiming for a frequency of twice weekly for two weeks

Primary outcomes

  1. 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 outcomes

  1. To document changes in lung function and 6 minute walk distance (6MWD) following infusion of MSC

    Time frame: 12 months

  2. To document survival post MSC infusion

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

The Prince Charles Hospital

Other Gov

Collaborators

  • Cell and Tissue Therapies Western Australia

Registry information

Acronym: MSC in OB

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Aug 5, 2010
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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