Safety Study of Bone-marrow Derived Mesenchymal Stromal Cells Associated With Endobronchial Valves in Emphysema

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

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-03-31

Brief Summary

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The combined use of one-way endobronchial valves and bone-marrow derived mesenchymal stromal cells in patients with severe pulmonary emphysema is safe and will contribute to increase quality of life.

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Detailed Description

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In addition to testing the safety of one-way endobronchial valves combined with bone-marrow derived mesenchymal stromal cells, the study will determine the systemic inflammatory potential of cell therapy measured by C-reactive protein levels (CRP), erythrocyte sedimentation rate (ESR) and complete blood count in peripheral blood. Finally, the study will aim at determining if other markers of inflammatory response and remodeling are modulated by this therapy.

Conditions

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Pulmonary Emphysema

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Valves plus cells

Bronchoscopy Five patients will be selected to receive bone-marrow derived mesenchymal stromal cells delivered bronchoscopically right before insertion of one-way endobronchial valves.

Group Type ACTIVE_COMPARATOR

Bronchoscopy

Intervention Type PROCEDURE

Bronchoscopic delivery of one-way valves and bone-marrow derived mesenchymal stromal cells.

Valves plus saline

Bronchoscopy Five patients will be selected for treatment with one-way endobronchial valves only, with saline injected prior to valve insertion.

Group Type PLACEBO_COMPARATOR

Bronchoscopy

Intervention Type PROCEDURE

Bronchoscopic delivery of one-way valves and bone-marrow derived mesenchymal stromal cells.

Interventions

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Bronchoscopy

Bronchoscopic delivery of one-way valves and bone-marrow derived mesenchymal stromal cells.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of severe heterogeneous emphysema (heterogeneity \> 15%), with heterogeneity defined as the difference between lobes in the percent area covered by parenchymal density greater than -950 Hounsfield Units.
* Estimation of collateral ventilation based on fissure with integrity ≥ 75%.
* Total lung capacity\> 100% predicted.
* Residual volume\> 150% predicted.
* Forced expiratory volume at the first minute \<45% predicted.
* Diffusing capacity of the lungs for carbon monoxide \<45% predicted.
* Optimal medical treatment.
* Limitations in daily physical activities.
* Minimum of 4 months without smoking
* Having family support.
* Stage ≥ 2 in modified Medical Research Council Dyspnea Scale (MMRC).

Exclusion Criteria

* Homogenous emphysema.
* Presence of collateral ventilation.
* Use of systemic corticosteroids (prednisone\> 20mg/day or equivalent).
* Pulmonary or extrapulmonary infection.
* Coronary heart disease and/or severe ventricular dysfunction.
* Significant renal or liver disease.
* Immunosuppressive disease.
* Active smoking.
* Cancer prognosis with survival \<2 years.
* Psychosocial problems.
* Pregnancy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No