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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2016-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Bronchiolitis Obliterans Lung Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MSC

Group Type EXPERIMENTAL

MSC

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No