Actively Recruiting
Cell Therapy Associated With Endobronchial Valve
Led by Hospital de Clinicas de Porto Alegre · Updated on 2022-12-14
34
Participants Needed
1
Research Sites
492 weeks
Total Duration
On this page
Sponsors
H
Hospital de Clinicas de Porto Alegre
Lead Sponsor
P
Pontifícia Universidade Católica do Paraná
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 people have COPD. Disease-related mortality is more than 3 million, representing 5% of all deaths, 90% of this mortality being concentrated in middle- and low-income countries. COPD can be subdivided into chronic bronchitis and emphysema. Emphysema, the focus of this project, is histologically defined by the permanent increase of the distal air spaces to the terminal bronchioles associated with the destruction of the alveolar septa in the lung. Approximately two-thirds of adult men and a quarter of women (most without dysfunction) will have well-defined emphysema, but often of limited extent. Mesenchymal stem cells (MSCs) have anti-inflammatory, anti-fibrotic, microbicide and repair potential. Regarding COPD, several authors have concentrated efforts in the investigation of the relationship between the severity of the condition and the various sources of adult stem cells. Apparently the lungs have a high chemotactic effect in relation to adult stem cells, since several studies have evidenced a high implantation (6-20%) of stem cells derived from bone marrow, administered systemically, in the pulmonary tissue of receptors. Therefore, MSCs has been tested in different lung diseases have no effective treatment, such as pulmonary fibrosis, acute respiratory distress syndrome, asthma, COPD positive results, such as reduction of fibrosis, reduction of proliferation inflammatory cells and cytokines, reduction of infectious processes and recovery of the histological changes caused by pulmonary emphysema. Based on these findings, the purpose of this project is to evaluate the safety and efficacy of endoscopic administration of bone marrow stem cells in patients with severe homogeneous emphysema and evaluating the feasibility, efficacy and safety of this procedure.
CONDITIONS
Official Title
Cell Therapy Associated With Endobronchial Valve
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of severe heterogeneous pulmonary emphysema with at least 10% of total lung affected or 25% of the target lobe with density less than -950HU
- Heterogeneity greater than 15 percentage points between target lobe and remaining lung on same side
- Low or no collateral ventilation estimated by fissure integrity over 95% or negative Chartis System
- Total lung capacity greater than 100% of predicted
- Residual volume greater than 175% of predicted
- Post-bronchodilator FEV1 less than 50% of predicted
- Post-bronchodilator DLCO less than 45% of predicted
- Body Mass Index between 18 and 35 Kg/m2
- Receiving optimized clinical treatment
- Limitation in daily physical activities
- Able to participate in pulmonary rehabilitation
- Preserved heart ventricular function with LVEF over 40%
- Smoking cessation for 4 months or more
- Dyspnea score MMRC of 2 or higher
You will not qualify if you...
- Homogeneous emphysema
- Estimated collateral ventilation with fissure integrity less than 75% on CT scan
- Continuous systemic corticosteroid therapy over 20mg daily of prednisone or equivalent
- Active lung or other infections
- Coronary heart disease or severe ventricular dysfunction
- Significant kidney or liver disease
- Immunosuppressive diseases
- Rheumatologic or orthopedic conditions limiting physical capacity
- Cognitive inability to understand study procedures
- Life expectancy estimated less than one year
- Active smoking
- Malignant tumors with expected survival less than 2 years
- Psychosocial problems
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035903
Actively Recruiting
Research Team
H
Hugo G Oliveira, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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