NCT04018729RecruitingPhase 2/3
Cell Therapy Associated With Endobronchial Valve
Bone Marrow-Derived Mesenchymal Stromal Cell Therapy Associated With Unidirectional Endobronchial Valve in Patients With Severe Pulmonary Emphysema: A Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 14 Dec 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 10 May 2019
- Start date
- Nov 2019
- Primary completion date
- Aug 2020
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Diseases
- COPD
- NCT number
- NCT04018729
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 34
- From Nov 2019 to the primary completion date, Aug 2020
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of continuous systemic corticosteroid therapy\> 20mg QD (quaque die, once a day) of prednisone (or equivalent)
Other illness
- 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;
Age
- Malignant neoplasia with estimated prognosis of survival \<2 years
Other
- 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%.
- Cognitive inability to understand study procedures;
- Impression by clinical research investigators with a lifespan of less than a year1;
- Active smoking
- Psychosocial problems
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.