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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 study about?

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.

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

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

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

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

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 Study?

  • 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
  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Algemeen Stedelijk Ziekenhuis Campus Aalst Aalst Belgium

Other Sites

Site Name City Country Status
Itthuo Bonheiden Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
30.06.2025

Trial locations

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.

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.

Trial ID:
2024-517031-51-00
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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