Pulmonary Emphysema
Conditions
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.
Interventions
PROCEDUREBronchoscopy
Bronchoscopic delivery of one-way valves and bone-marrow derived mesenchymal stromal cells.
Sponsors
Ministry of Health, Brazil
National Research Council, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Universidade Federal do Rio de Janeiro
Pontifícia Universidade Católica do Paraná
Hospital de Clinicas de Porto Alegre
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of lung deficits during the procedure and/or in the 4 months follow-up | 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil
Outcome results
None listed