Status:
RECRUITING
Cell Therapy Associated With Endobronchial Valve
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Collaborating Sponsors:
Pontifícia Universidade Católica do Paraná
Universidade Federal do Rio de Janeiro
Conditions:
Chronic Obstructive Pulmonary Disease Severe
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Chronic obstructive pulmonary disease (COPD) is one of the most common diseases worldwide and is considered a public health problem. The World Health Organization estimates that about 210 million peop...
Eligibility Criteria
Inclusion
- Diagnosis of severe heterogeneous pulmonary emphysema (at least 10% of total lung parenchyma or 25% of target lobe with density \< -950HU);
- Heterogeneity\> 15pp (difference of at least 15 percentage points of lung parenchyma with density greater than -950HU between the treated lobe(s) and the remaining lung on the same side)
- Estimates of low or non-existent collateral ventilation (fissure integrity\> 95% measured by VIDA Diagnostics or collateral ventilation measured by negative Chartis® System)
- Total lung capacity\> 100% of predicted
- Residual volume\> 175% of predicted
- FEV1 \<50% of predicted post-bronchodilator
- DLCO (diffusing capacity of the lungs for carbon monoxide) \<45% of predicted post-bronchodilator
- Body Mass Index (BMI) Greater than 18Kg/m2 and less than 35Kg/m2.
- Optimized clinical treatment
- Daily physical activities limitation
- Possibility of pulmonary rehabilitation
- Preserved ventricular function (LVEF\> 40%)
- Cessation of smoking ≥ 4 months
- Dyspnea MMRC ≥ 2
Exclusion
- Homogeneous emphysema
- Estimated collateral ventilation observed on CT scanned by VIDA vision software (VIDA vision®, VIDA Diagnostics, Iowa-USA) - Fissure integrity on target lobe less than 75%.
- Use of continuous systemic corticosteroid therapy\> 20mg QD (quaque die, once a day) of prednisone (or equivalent)
- Active lung or extra pulmonary infection
- Coronary heart disease and/or severe ventricular dysfunction
- Significant renal or hepatic disease
- Immunosuppressive disease
- Rheumatologic or orthopedic disease limiting physical capacity;
- Cognitive inability to understand study procedures;
- Impression by clinical research investigators with a lifespan of less than a year1;
- Active smoking
- Malignant neoplasia with estimated prognosis of survival \<2 years
- Psychosocial problems
- Pregnancy
Key Trial Info
Start Date :
November 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2029
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04018729
Start Date
November 19 2019
End Date
April 30 2029
Last Update
December 14 2022
Active Locations (1)
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1
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035903