Cell therapy combined with an endobronchial valve for severe emphysema
Bone Marrow-Derived Mesenchymal Stromal Cell Therapy Associated With Unidirectional Endobronchial Valve in Patients With Severe Pulmonary Emphysema: A Randomized Clinical Trial
This study is testing whether combining stem cell therapy with a special valve can help people with severe emphysema breathe better and improve their quality of life.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital de Clinicas de Porto Alegre Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Porto Alegre, Rio Grande do Sul) |
| Trial ID | NCT04018729 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of mesenchymal stem cells in conjunction with the Zephyr Endobronchial Valve to treat patients with severe heterogeneous pulmonary emphysema. The study aims to assess the safety and efficacy of this combined approach in improving lung function and quality of life for patients suffering from chronic obstructive pulmonary disease (COPD). Participants will undergo a thorough evaluation to ensure they meet specific eligibility criteria, including lung capacity and function measurements. The trial is designed to provide insights into the potential benefits of regenerative medicine in managing severe emphysema.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with severe heterogeneous pulmonary emphysema who meet specific lung function criteria.
Not a fit: Patients with mild emphysema or those who do not meet the strict eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve lung function and quality of life for patients with severe emphysema.
How similar studies have performed: Other studies have shown promise in using stem cell therapies for lung conditions, but this specific combination approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Porto Alegre, Rio Grande do Sul
- Hospital de Clinicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
Study contacts
- Principal investigator: Hugo G Oliveira, PhD — Hospital de Clinicas de Porto Alegre
- Study coordinator: Hugo G Oliveira, PhD
- Email: hugo@hugooliveira.org
- Phone: +55 51 3359-8241
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.