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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Bronchoscopic delivery of one-way valves and bone-marrow derived mesenchymal stromal cells.
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
Absence of lung deficits during the procedure and/or in the 4 months follow-up
Time frame: 4 months
Quality of Life
St. George Respiratory Questionnaire
Time frame: 120 days
Pulmonary function
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
Time frame: 120 days
Inflammation
Collection of blood samples for determination of C-reactive protein (CRP), erythrocyte
Time frame: 120 days
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