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| Name | Class |
|---|---|
| Ministry of Health, Brazil | OTHER_GOV |
| National Research Council, Brazil | OTHER |
| Conselho Nacional de Desenvolvimento Científico e Tecnológico | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valves plus cells | Active Comparator | 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 | Placebo Comparator | Bronchoscopy Five patients will be selected for treatment with one-way endobronchial valves only, with saline injected prior to valve insertion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchoscopy | Procedure | Bronchoscopic delivery of one-way valves and bone-marrow derived mesenchymal stromal cells. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absence of lung deficits during the procedure and/or in the 4 months follow-up | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | St. George Respiratory Questionnaire | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hugo G Oliveira, MD, PhD | Hospital de Clínicas de Porto Alegre | Principal Investigator |
| Patricia RM Rocco, MD, PhD | Universidade Federal do Rio de Janeiro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pontificia Universidade Catolica do Parana | Curitiba | Paraná | 80215-901 | Brazil | ||
| Universidade Federal do Rio de Janeiro |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21656291 | Background | Abreu SC, Antunes MA, Pelosi P, Morales MM, Rocco PR. Mechanisms of cellular therapy in respiratory diseases. Intensive Care Med. 2011 Sep;37(9):1421-31. doi: 10.1007/s00134-011-2268-3. Epub 2011 Jun 9. | |
| 16840401 | Background | de Oliveira HG, Macedo-Neto AV, John AB, Jungblut S, Prolla JC, Menna-Barreto SS, Fortis EA. Transbronchoscopic pulmonary emphysema treatment: 1-month to 24-month endoscopic follow-up. Chest. 2006 Jul;130(1):190-9. doi: 10.1378/chest.130.1.190. |
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| ID | Term |
|---|---|
| D011656 | Pulmonary Emphysema |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001999 | Bronchoscopy |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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| Rio de Janeiro State Research Supporting Foundation (FAPERJ) |
| OTHER_GOV |
| Universidade Federal do Rio de Janeiro | OTHER |
| Pontifícia Universidade Católica do Paraná | OTHER |
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| 120 days |
| Inflammation | Collection of blood samples for determination of C-reactive protein (CRP), erythrocyte | 120 days |
| Rio de Janeiro |
| Rio de Janeiro |
| 21941-902 |
| Brazil |
| Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |