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

Bone-marrow Derived Mesenchymal Stromal Cells Associated With One-way Endobronchial Valves in Patients With Pulmonary Emphysema: Safety Study

NCT01872624•Hospital de Clinicas de Porto Alegre

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.
+1 more criteria

Locations (3)

Pontificia Universidade Catolica do Parana

Curitiba, Paraná, Brazil

Universidade Federal do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Key Dates

Start Date

May 1, 2013

Primary Completion Date

December 1, 2014

Completion Date

March 1, 2015

Last Updated

March 25, 2015

Enrollment

ACTUAL participants

Conditions

Pulmonary Emphysema

Interventions

Bronchoscopy

PROCEDURE

Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency

NCT02796937

Pulmonary Emphysema in Alpha-1 Antitrypsin Deficiency

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COMPLETEDPHASE2

PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT00683722

Pulmonary Disease, Chronic ObstructivePulmonary Emphysema+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 25, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency

PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Implantation of Endobronchial Valves Versus Intrabronchial Valves in Patients With Severe Heterogeneous Emphysema

Diagnostic Value of Ultralow-dose Computed Tomography for the Detection of Pulmonary Nodules and Lung Parenchym Alterations Compared to Standard-dose CT

US Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study

Doxycycline and Airway Inflammation in Chronic Obstructive Pulmonary Disease (COPD)