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

Lung Transplantation Clinical Trial

— MSC in OB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01175655
• Other study ID #: EC 28105
• Status: Completed
• Phase: Phase 1
• Start date: February 2010
• Est. completion date: July 2016

Study information

• Verified date: April 2022
• Source: The Prince Charles Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis Obliterans
• Lung Transplantation

Intervention

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

Locations

Country	Name	City	State
Australia	TPCH	Brisbane	Queensland
Australia	RPH	Perth	Western Australia

Sponsors (2)

Lead Sponsor	Collaborator
The Prince Charles Hospital	Cell and Tissue Therapies Western Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To document changes in lung function and 6 minute walk distance (6MWD) following infusion of MSC		12 months
Secondary	To document survival post MSC infusion		12 months