Stem Cell Therapy With a Lung Valve for Severe Emphysema

Plain-English translation of NCT04018729 on ClinicalTrials.gov ↗ ·

What is this trial?

This trial is testing a new combination treatment for people with severe emphysema — a lung disease that makes breathing difficult. The treatment uses bone marrow-derived mesenchymal stromal cells (special healing cells from bone marrow) paired with an endobronchial valve (a one-way valve placed inside the airways during a minimally invasive procedure). Researchers believe these stem cells may help repair damaged lung tissue and reduce inflammation, and when combined with the valve, could significantly improve how well your lungs work.

Most people with severe emphysema have limited treatment options that actually slow or reverse the disease. Studies suggest that stem cells have powerful anti-inflammatory and repair abilities, and that lungs naturally attract these cells when they're introduced into the body. This trial combines those findings to test whether this new approach can improve lung function and quality of life for patients with severe emphysema.

Do you qualify?

You likely qualify if…

you have been diagnosed with severe emphysema affecting a specific part of your lung
you have significant shortness of breath that limits your daily activities
your lung function tests show FEV1 below 50% of predicted and your residual volume above 175% of predicted
you have not smoked for at least 4 months
you are willing and able to participate in pulmonary rehabilitation
your heart function is preserved (ejection fraction greater than 40%)

You likely don't qualify if…

you have emphysema that is spread evenly throughout both lungs (homogeneous emphysema)
you are currently taking high-dose steroids daily (more than 20mg of prednisone or equivalent)
you have an active lung or other infection
you have severe heart disease, kidney disease, liver disease, or immunosuppressive conditions
you are currently smoking or have significant psychosocial problems that would interfere with treatment

What participation looks like

If you qualify, you will be randomly assigned to receive either the combination of stem cell therapy plus the endobronchial valve, or the valve alone. The stem cells or valve will be delivered through a bronchoscope — a thin, flexible tube passed down your airways — which is a minimally invasive procedure. You'll need to be medically optimized before the procedure and committed to pulmonary rehabilitation afterward. The trial will monitor your lung function, breathing ability, and quality of life over time to see if the treatment helps you breathe better and improves your daily activities.

Stem Cell Therapy With a Lung Valve for Severe Emphysema

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)