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Testing allogeneic adipose tissue-derived mesenchymal stromal cells in patients with recently diagnosed non-ischemic heart failure with reduced ejection fraction

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves patients with non-ischemic heart failure with reduced ejection fraction, which is a condition where the heart muscle is weakened and cannot pump blood effectively throughout the body, but this weakness is not caused by blocked arteries. The heart's pumping ability, measured by something called ejection fraction, is lower than normal. The treatment being tested is called C2C_ASC110, which consists of allogenic adipose-tissue-derived mesenchymal stem cells. These are special cells taken from the fat tissue of healthy donors that have the ability to help repair damaged tissue. Some patients will receive this cell therapy while others will receive a placebo.

The purpose of the study is to find out if giving this stem cell treatment through an infusion into the vein can help restore heart function in people who have been recently diagnosed with this type of heart failure. The study will compare how well the heart works in patients who receive the stem cell treatment versus those who receive the placebo. Patients in the study will receive their assigned treatment through infusions and will be followed for twelve months to see how their heart function changes over time.

During the study, doctors will measure various aspects of heart function using different methods. They will check the heart's pumping ability and the size of the heart chambers at different time points after the treatment. Doctors will also assess how patients feel and function in their daily lives by checking their symptoms, their ability to walk for six minutes, and asking them to complete questionnaires about their quality of life. Blood tests will be performed to measure a substance that indicates heart stress. The study will also carefully monitor any unwanted effects or reactions that patients may experience to ensure the treatment is safe.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline Assessment
At the start of the trial, your heart function will be assessed. This includes measuring your left ventricular ejection fraction, which shows how well your heart pumps blood. This measurement will be done using imaging techniques such as echocardiography (ultrasound of the heart), CT scan, or MRI scan.
Your Pro-BNP blood levels will be measured. This is a substance in your blood that indicates how much strain your heart is under.
Your symptoms will be evaluated using the NYHA classification, which describes how much your heart condition limits your daily activities.
You will complete a 6-minute walking test to assess your physical capacity.
You will fill out questionnaires called KCCQ and EQ5D5L to evaluate your quality of life and how your heart condition affects your daily functioning.
Additional heart measurements will be taken using echocardiography.
Step 2
Treatment Administration
You will receive either the investigational treatment called C2C_ASC110 or a placebo. The investigational treatment contains allogeneic adipose-tissue-derived mesenchymal stem cells, which are cells obtained from fat tissue of a donor. The placebo is a freezing medium called CryoStor CS10 that does not contain active cells.
The treatment will be given through intravenous infusion, which means it will be delivered directly into your vein.
Neither you nor your medical team will know whether you are receiving the active treatment or placebo during the trial. This is called a double-blind study design.
The exact number of infusions and the schedule for administration will be determined according to the trial protocol.
Step 3
Follow-up at 6 Months After Last Infusion
Six months after your last infusion, your heart function will be assessed again.
The left ventricular ejection fraction will be measured to determine if there has been any change compared to the baseline measurement. This is the main measure used to evaluate whether the treatment is effective.
Additional heart measurements will be performed.
Step 4
Follow-up at 7 Months
At 7 months, your heart function will be evaluated again.
Measurements will include left ventricular ejection fraction, left ventricular end-systolic volume (the amount of blood remaining in the heart after it contracts), and left ventricular end-diastolic volume (the amount of blood in the heart before it contracts).
Your NYHA classification will be assessed to see if your symptoms have changed.
You will perform another 6-minute walking test.
You will complete the KCCQ and EQ5D5L questionnaires again.
Your Pro-BNP blood levels will be measured.
Additional echocardiographic measurements will be taken.
Step 5
Follow-up at 12 Months
At 12 months, a comprehensive assessment will be performed.
Measurements will include left ventricular ejection fraction, left ventricular end-systolic volume, and left ventricular end-diastolic volume.
Your NYHA classification will be assessed.
You will perform another 6-minute walking test.
You will complete the KCCQ and EQ5D5L questionnaires.
Your Pro-BNP blood levels will be measured.
Additional echocardiographic measurements will be taken.
Any serious adverse reactions (serious unwanted effects related to the treatment) and suspected unexpected serious adverse reactions (serious unwanted effects that were not anticipated) will be evaluated to assess the safety of the treatment.

Who can join the trial?

5 criteria

You must be older than 18 years of age
You have been diagnosed with non-ischemic heart failure, which is a condition where your heart muscle is weakened but not due to blocked arteries, with an initial LVEF (a measurement showing how well your heart pumps blood with each beat) of 40% or less, and your heart failure medications have been adjusted to the highest dose you can tolerate within the last 12 months
You have symptoms of heart failure classified as NYHA II-III, which means you experience some limitation in physical activity or are comfortable at rest but less than ordinary activity causes symptoms
Your LVEF is 45% or less as confirmed by a heart imaging test such as echocardiography (ultrasound of the heart), CT scan (a special type of X-ray), or MRI (magnetic resonance imaging) done after your heart failure medications were adjusted. If you have a heart device implanted such as an ICD (a device that monitors heart rhythm and can deliver shocks if needed) or CRT (a device that helps coordinate heart contractions), the reduced LVEF must be documented at least 1 and 3 months after the device was placed
Your blood test shows a Pro-BNP level (a substance in your blood that indicates heart stress) greater than 300 pg/ml if you have a normal heart rhythm called sinus rhythm, or greater than 422 pg/ml if you have an irregular heart rhythm called atrial fibrillation

Who cannot join the trial?

4 criteria

The study information does not list specific exclusion criteria, which are conditions or situations that would prevent you from taking part in this clinical trial
To find out if you are able to participate, you will need to be evaluated by the research team during a screening visit, which is an appointment where doctors check if you meet all requirements for the study
General reasons that often prevent participation in clinical trials may include having certain other medical conditions, taking specific medications, being pregnant or planning to become pregnant, or having had recent medical procedures
The research team will review your complete medical history and current health status to determine if you can safely participate

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Herlev Hospital
Verified
Herlev, Denmark
Rigshospitalet
Verified
Copenhagen, Denmark
Roskilde University
Responsive
Roskilde, Denmark

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Investigated drugs

C2C_ASC110 is an experimental treatment made from mesenchymal stromal stem cells. These special cells come from the fatty tissue of a donor and are given to patients through an infusion into a vein. In this study, researchers want to see if these cells can help improve heart function in people who have recently been diagnosed with a type of heart failure where the heart muscle has become weak but not because of blocked arteries.

What is already known about the treatment

C2C_ASC110
This is an experimental cell therapy given through an intravenous infusion (injection into a vein) that is currently being tested in clinical trials and is not yet approved for general medical use. The treatment uses special cells called mesenchymal stromal stem cells that are obtained from fatty tissue of donors and is being studied for patients who have recently been diagnosed with a type of heart failure where the heart muscle is weakened but not caused by blocked arteries. These cells work by potentially helping to repair and regenerate damaged heart tissue at the cellular level, aiming to improve the heart's ability to pump blood effectively.
CryoStor CS10
This is a specialized preservation solution used as a placebo (inactive comparison treatment) in this clinical trial, administered through intravenous infusion (injection into a vein). It is a commercially available medical product commonly used in research and clinical settings to preserve cells and tissues at very low temperatures. In this study, it serves as the control treatment to compare against the active cell therapy, allowing researchers to determine whether any improvements in heart function are truly due to the stem cells or other factors.

Investigated diseases

Non-ischemic Heart Failure with Reduced Ejection Fraction – This is a condition where the heart muscle becomes weakened and cannot pump blood effectively throughout the body, but the weakness is not caused by blocked arteries or previous heart attacks. The heart's left ventricle, which is the main pumping chamber, loses its ability to contract properly and eject adequate amounts of blood with each heartbeat. As the condition progresses, the heart enlarges and its walls may become thinner or thicker in an attempt to compensate for the reduced pumping ability. Patients typically experience shortness of breath, fatigue, swelling in the legs and ankles, and reduced ability to perform physical activities. The ejection fraction, which measures the percentage of blood pumped out of the heart with each beat, falls below normal levels. Over time, fluid can build up in the lungs and other parts of the body as the heart struggles to meet the body's demands for oxygen-rich blood.