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Study of cardiac atrial stem cells injected into heart muscle for treating advanced heart failure in patients with prior heart attack and reduced heart function

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What is this trial about?

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

This study focuses on treating patients with heart failure, specifically those who have experienced a myocardial infarction (heart attack) and have reduced heart function. The treatment being investigated involves injecting special cells called cardiac atrial stem cells directly into the heart muscle. These cells are obtained from donor heart tissue and are being tested to help improve heart function in patients with damaged heart tissue.

The purpose of this research is to evaluate whether injecting these stem cells into the heart muscle is safe for patients with advanced heart failure. The treatment involves a surgical procedure where the cells are injected directly into specific areas of the heart that have been damaged by the previous heart attack. The study will monitor patients for any heart-related complications and track their overall health after receiving the treatment.

During the study, patients will receive the stem cell treatment along with their standard heart care. The research team will perform various tests to check heart function, including echocardiography (heart ultrasound) and magnetic resonance imaging (MRI) scans. Patients will be monitored regularly after the procedure to assess their recovery and any changes in their heart condition.

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
Initial evaluation
Your heart function will be assessed through various tests including echocardiogram, MRI scan, or other imaging methods to confirm heart condition
Laboratory tests will be performed to ensure you can safely undergo the procedure
If you are a woman who can become pregnant, a pregnancy test will be conducted
Step 2
Pre-procedure preparation
Your heart will be examined to confirm the presence of scar tissue from previous heart attack using special imaging (MRI with contrast)
Your heart pumping function (ejection fraction) must be between 25% and 45% to proceed with the treatment
The medical team will determine if you need additional heart procedures (CABG - bypass surgery) along with the cell treatment
Step 3
Treatment procedure
You will receive an injection of cardiac atrial stem cells directly into your heart muscle
The procedure will be performed during surgery
The cells will be delivered to areas of your heart affected by previous heart attack
Step 4
Follow-up monitoring
Your heart function will be regularly monitored through various tests
A walking test (Six-Minute Walk Test) will be performed to assess your exercise capacity
Your heart failure symptoms will be evaluated using a classification system (NYHA class)
The size of the damaged heart area will be measured
The medical team will monitor for any heart-related complications or other health issues
Step 5
Study duration
The study is scheduled to run from June 2025 through December 2026
You will need to attend all scheduled follow-up visits during this period
If you are a woman who can become pregnant, you must use effective birth control throughout the study duration

Who can join the trial?

11 criteria

Must be over 18 years old (male or female)
Must have had a documented heart attack (myocardial infarction) caused by narrowed heart arteries
Must have an area of heart muscle that doesn't work properly, as shown on heart imaging tests like echocardiography (ultrasound of the heart), MRI, or other scans
Must have scar tissue in the heart visible on MRI scan
Must have a heart pumping function (ejection fraction) between 25% and 45%
Must need heart bypass surgery (CABG) in the area affected by the heart attack
Must have normal blood test results that allow for surgery
check
Women who can become pregnant must:
- Have a negative pregnancy test
- Use effective birth control for 2 months before the study and throughout the study period
- Must be able to understand and sign the informed consent form
- Must be physically and mentally able to follow all study procedures and attend follow-up visits

Who cannot join the trial?

15 criteria

Age below 18 years or above 65 years
Presence of active cancer or history of cancer in the past 5 years
Previous heart attack (myocardial infarction) within the last 30 days
Current participation in other clinical trials
Presence of heart tumors or history of heart tumors
Severe kidney or liver disease
Active infection or fever
Pregnancy or breastfeeding
Uncontrolled diabetes (high blood sugar levels)
History of severe allergic reactions
Mental conditions that could affect ability to provide informed consent
Blood disorders that increase bleeding risk
Recent major surgery (within last 3 months)
Heart rhythm problems that are not controlled by medication
Substance abuse or alcohol dependency

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Verified sites

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Algemeen Stedelijk Ziekenhuis Campus Aalst
Aalst, Belgium

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Investigated drugs

Cardiac Atrial Stem Cells
are specialized cells taken from heart tissue (specifically from the atrial appendage). These cells are injected directly into the heart muscle during surgery. They are being studied as a potential treatment for patients with severe heart failure caused by previous heart attacks. The stem cells are obtained from donors (allogeneic), which means they come from someone other than the patient receiving the treatment.
Intramyocardial Injection
is the delivery method used in this trial, where the stem cells are injected directly into the heart muscle tissue during a surgical procedure. This technique allows for precise placement of the cells in the areas of the heart that have been damaged by previous heart attacks.

What is already known about the treatment

Cardiac Atrial Stem Cells – An investigational biological therapy administered through direct intramyocardial injection during cardiac procedures for treating advanced ischemic heart failure and chronic myocardial infarction. This novel cell-based treatment utilizes stem cells derived from cardiac atrial appendage tissue and is currently being evaluated in Phase I-IIa clinical trials to assess its safety and preliminary effectiveness. The therapy works by potentially promoting cardiac tissue regeneration and improving heart function in patients with left ventricular dysfunction, though its exact molecular mechanism is still under investigation. This allogeneic treatment represents an emerging approach in regenerative medicine for cardiac conditions, with researchers specifically monitoring for major adverse cardiac events to establish its safety profile.

Investigated diseases

Heart Failure
A chronic condition where the heart cannot pump blood effectively enough to meet the body's needs. The heart muscle becomes weaker over time or has difficulty filling with blood. This causes blood to back up in the lungs and other parts of the body, leading to fluid retention and swelling. Common symptoms include shortness of breath, fatigue, and swelling in the legs and ankles. The condition can develop gradually over time as the heart becomes progressively weaker.
Myocardial Infarction
A condition where blood flow to a part of the heart muscle is blocked, causing damage to the heart tissue. It occurs when one or more coronary arteries become blocked, usually due to buildup of fatty deposits. The affected heart muscle begins to die from lack of oxygen. The damage can cause immediate symptoms including chest pain, shortness of breath, and discomfort in other areas of the upper body.