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

NCT01175655 | Completed Phase 1 DMC

• 1 other identifier: EC 28105
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Bronchiolitis Obliterans; Lung Transplantation

Keywords

Mesenchymal stromal cells; Bronchiolitis obliterans; Lung transplant

Outcome Measures

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.

  12 months

Secondary Outcomes (2)

• 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

Study Arms (1)

MSC

EXPERIMENTAL

Other: MSC

Interventions

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

MSC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Prince Charles Hospital: lead
• Cell and Tissue Therapies Western Australia: collaborator

Study Sites (2)

TPCH

Brisbane, Queensland, 4032, Australia

Location

RPH

Perth, Western Australia, 6000, Australia

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans

Condition Hierarchy (Ancestors)

Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Daniel Chambers, A/Prof

  The Prince Charles Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: August 5, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2016
• Last Updated: April 26, 2022

Record last verified: 2022-04

Locations

AU (2)