RecruitingPhase 2Phase 3NCT04018729

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


Sponsor

Hospital de Clinicas de Porto Alegre

Enrollment

34 participants

Start Date

Nov 19, 2019

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two treatments for people with severe emphysema (a lung disease where air sacs are permanently damaged): endobronchial valves (small one-way valves placed inside the airways to deflate the most damaged part of the lung) plus cell therapy using stem cells injected into the lung. The goal is to see if this combination can improve breathing and quality of life more than either treatment alone. **You may be eligible if...** - You have confirmed severe emphysema where the damage is concentrated in one lobe of the lung - Your lung function tests show significantly reduced airflow (FEV1 < 50% of expected) - Your lungs are significantly over-inflated (total lung capacity > 100%, residual volume > 175%) - There is little or no air leaking between the targeted and remaining lung tissue **You may NOT be eligible if...** - Your emphysema is evenly spread throughout both lungs - You have too much air collateral flow preventing valve placement - You have other conditions that make bronchoscopy or cell therapy unsafe - Your BMI is below 18 (underweight) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEZephyr Endobronchial Valve

Endoscopic lung volume reduction therapy.

BIOLOGICALMarrow-derived mesenchymal stromal cell

Mesenchymal stem cells have anti-inflammatory, anti-fibrotic, microbicide and repair potential.


Locations(1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

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NCT04018729


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