Clinical Trial: Safety Study of Bone-marrow Derived Mesenchymal Stromal Cells Associated With Endobronchial Valves in Emphysema
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Bone-marrow Derived Mesenchymal Stromal Cells Associated With One-way Endobronchial Valves in Patients With Pulmonary Emphysema: Safety Study
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 Summary: 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.
Sponsor: Hospital de Clinicas de Porto Alegre
Current Primary Outcome: Absence of lung deficits during the procedure and/or in the 4 months follow-up [ Time Frame: 4 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Quality of Life [ Time Frame: 120 days ]St. George Respiratory Questionnaire
- Pulmonary function [ Time Frame: 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 [ Time Frame: 120 days ]Collection of blood samples for determination of C-reactive protein (CRP), erythrocyte
Original Secondary Outcome: Same as current
Information By: Hospital de Clinicas de Porto Alegre
Dates:
Date Received: June 5, 2013
Date Started: May 2013
Date Completion:
Last Updated: March 24, 2015
Last Verified: March 2015
