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

Not Applicable

Completed

• Conditions: Pulmonary Emphysema
• Interventions: Procedure: Bronchoscopy

• Registration Number: NCT01872624
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief 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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-05
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-07
• Primary Completion: 2014-12
• Status Verified: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Valves plus cells	Bronchoscopy	Bronchoscopy Five patients will be selected to receive bone-marrow derived mesenchymal stromal cells delivered bronchoscopically right before insertion of one-way endobronchial valves.
Valves plus saline	Bronchoscopy	Bronchoscopy Five patients will be selected for treatment with one-way endobronchial valves only, with saline injected prior to valve insertion.

Primary Outcome Measures

Name	Time	Method
Absence of lung deficits during the procedure and/or in the 4 months follow-up	4 months

Secondary Outcome Measures

Name	Time	Method
Quality of Life	120 days	St. George Respiratory Questionnaire
Pulmonary function	120 days	Spirometry, flow-volume curve, post-bronchodilator test, determination of residual volume, airway resistance by plethysmography, diffusing capacity of the lung for carbon monoxide, and six-minute walk test
Inflammation	120 days	Collection of blood samples for determination of C-reactive protein (CRP), erythrocyte

Trial Locations

Locations (3)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil

Pontificia Universidade Catolica do Parana; 🇧🇷 Curitiba, PR, Brazil

Universidade Federal do Rio de Janeiro; 🇧🇷 Rio de Janeiro, RJ, Brazil