Clinical trial NCT01175655: A Study to Evaluate the Potential of Mesenchymal Stromal Cells to Treat Obliterative Bronchiolitis After Lung Transplantation
Official title: A Study to Evaluate the Potential of Mesenchymal Stromal Cells to Treat Obliterative Bronchiolitis After Lung Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bronchiolitis Obliterans
Lung Transplantation
Keywords: Mesenchymal stromal cells
Bronchiolitis obliterans
Lung transplant
Lead sponsor: The Prince Charles Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Cell and Tissue Therapies Western Australia
First posted: 2010-08-05
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: To document changes in lung function and 6 minute walk distance (6MWD) following infusion of MSC
timeFrame: 12 months
measure: To document survival post MSC infusion
timeFrame: 12 months
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: TPCH
state: Queensland
city: Perth
country: Australia
facility: RPH
state: Western Australia
Study officials:
affiliation: The Prince Charles Hospital
name: Daniel Chambers, A/Prof
role: PRINCIPAL_INVESTIGATOR
References: