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

Phase 1

Completed

• Conditions: Lung Transplantation; Bronchiolitis Obliterans
• Interventions: Other: MSC

• Registration Number: NCT01175655
• Lead Sponsor: The Prince Charles Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-06-25
• Study First Submitted QC: 2010-08-04
• Study First Posted: 2010-08-05
• Primary Completion: 2015-07
• Study Completion: 2016-07
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MSC	MSC	-

Primary Outcome Measures

Name	Time	Method
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.	12 months

Secondary Outcome Measures

Name	Time	Method
To document changes in lung function and 6 minute walk distance (6MWD) following infusion of MSC	12 months
To document survival post MSC infusion	12 months

Trial Locations

Locations (2)

TPCH; 🇦🇺 Brisbane, Queensland, Australia

RPH; 🇦🇺 Perth, Western Australia, Australia