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New treatment option for Chronic Obstructive Pulmonary Disease Severe
Official title Cell Therapy Associated With Endobronchial Valve
ClinicalTrials.gov ID: NCT04018729
What this study is testing
What is Marrow-derived mesenchymal stromal cell?
Marrow-derived mesenchymal stromal cell is an investigational medicine, being studied as a potential treatment for chronic obstructive pulmonary disease severe.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Estimates of low or non-existent collateral ventilation (fissure integrity\> 95% measured by VIDA Diagnostics or collateral ventilation measured by...
- Total lung capacity\> 100% of predicted
- Residual volume\> 175% of predicted
You likely can't join if
- Homogeneous emphysema
- Estimated collateral ventilation observed on CT scanned by VIDA vision software (VIDA vision®, VIDA Diagnostics, Iowa-USA) - Fissure integrity on...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Porto Alegre, Rio Grande do Sul, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Porto Alegre, Rio Grande do Sul, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.