Cell therapy combined with an endobronchial valve for severe emphysema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• High-flow oxygen therapy for patients on long-term oxygen therapy

  This study is testing if adding high-flow oxygen therapy at night can help people with COPD or interstitial lung disease who are already using long-term oxygen therapy feel better.

  Recruiting at 2 sites Skane University Hospital · Karlskrona, Blekinge County and 1 other locations · NCT06247397

• Predicting Exacerbation Risk in Severe COPD Patients

  This study is trying to see if analyzing gut bacteria can help predict which patients with severe COPD are more likely to have worsening symptoms.

  Recruiting Beijing Chao Yang Hospital · Beijing, Beijing Municipality · NCT06198309

• Examining respiratory and heart changes in COPD patients

  This study looks at how chronic obstructive pulmonary disease (COPD) affects heart health and quality of life in people aged 40 and older with moderate to severe COPD.

  Recruiting Lithuanian University of Health Sciences · Kaunas, Kaunas County · NCT06072690

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.