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Study on the Safety and Effectiveness of Engineered Human Myocardium for Patients with Terminal Heart Failure

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What is this trial about?

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

This clinical trial is focused on studying the treatment of heart failure, a condition where the heart is unable to pump blood effectively. The treatment being tested is called Engineered Human Myocardium (EHM), which is an implant made from special cells known as allogeneic induced pluripotent stem cells-derived cardiomyocytes and stromal cells. These cells are designed to help the heart function better by acting as a biological support tissue.

The purpose of the study is to evaluate the safety and effectiveness of this new treatment in patients with severe heart failure. Participants in the study will receive the EHM implant through a surgical procedure. The study will monitor participants for any side effects and assess improvements in heart function over time. The study will also look at how the treatment affects the thickness and strength of the heart muscle.

Throughout the study, participants will undergo various tests, such as echocardiography and MRI, to measure heart function and structure. The study will also track the occurrence of any major heart-related events, like heart attacks or strokes, and monitor the overall health and quality of life of the participants. The study aims to provide valuable information on whether this innovative treatment can offer a new option for those suffering from severe heart failure.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, heart condition, and previous medical procedures.

    Written informed consent is required to participate.

  2. Step 2

    Preparation for implantation

    Preparation involves assessing the heart condition using imaging techniques like echocardiography, MRI, or CT.

    A stable condition is necessary for the surgical procedure, which may involve a mini-thoracotomy or open-chest surgery.

  3. Step 3

    Implantation of <b>engineered human myocardium (EHM)</b>

    The EHM, derived from stem cells, is implanted into the heart to assist its function.

    The procedure is performed through surgical intervention, targeting specific areas of the heart.

  4. Step 4

    Post-implantation monitoring

    Monitoring for adverse events, particularly arrhythmic events and disease progression, occurs within 28 days after the procedure.

    Regular follow-up visits are scheduled to assess the heart's structural and functional improvements.

  5. Step 5

    Long-term follow-up

    The study continues to monitor for major adverse cardiac events, immune rejection, and changes in heart function.

    Patient outcomes are evaluated through tests like the six-minute walk test and quality of life assessments.

  6. Step 6

    Completion of study

    The study is estimated to conclude by June 2025.

    Final assessments will determine the overall safety and efficacy of the EHM treatment.

Who can join the trial?

8 criteria

  • Have heart failure with reduced ejection fraction, which means the heart is not pumping as well as it should. This is checked using special imaging tests like echocardiography, MRI, or CT.
  • Have at least one part of the heart that is not moving properly, which helps doctors know where to place the treatment.
  • Be in a stable condition that allows for certain types of heart surgery, either through a small cut on the side of the chest or by opening the chest, especially if there is a problem with the right side of the heart. This is measured using a test called the Tricuspid Annular Plane Systolic Excursion (TAPSE), which should be less than 16 mm.
  • Be between 18 and 80 years old.
  • Have had a device implanted in the heart that helps with its rhythm, like an ICD (Implantable Cardioverter Defibrillator) or CRT-D (Cardiac Resynchronization Therapy Defibrillator), which also records heart events.
  • Be in New York Heart Association (NYHA) Class III or IV, which means having more severe heart failure symptoms, even with the best medical treatment.
  • Be willing and able to sign a form agreeing to participate in the study.
  • If female and able to have children, agree to use a reliable method of birth control during the study.

Who cannot join the trial?

5 criteria

  • Patients who do not have heart failure cannot participate. Heart failure is a condition where the heart doesn't pump blood as well as it should.
  • Patients with a heart function better than 35% are excluded. This means their heart is working better than the study requires.
  • Patients with a right ventricle dysfunction measurement (TAPSE) of 16 mm or more cannot join. TAPSE is a test that measures how well the right side of the heart is working.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population are not eligible. This means people who might need extra protection or care.
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Investigated drugs

Engineered Human Myocardium (EHM) is a therapy being tested for its safety and effectiveness in patients with severe heart failure. This therapy involves using heart tissue that has been created from stem cells. The goal is to help the heart pump better by using this engineered tissue as a support for the heart's function. It is being studied to see if it can improve heart performance and help patients with very weak heart function.

What is already known about the treatment

Engineered Human Myocardium (EHM) – This innovative treatment is administered as a biological ventricular assist tissue, specifically designed for patients with terminal heart failure. Currently, it is in the clinical trial phase, with ongoing research to evaluate its safety and effectiveness. The main therapeutic indication is for heart failure, particularly in severe cases where traditional treatments may not suffice. At the molecular level, EHM works by integrating with the heart tissue to improve its function, potentially offering a new avenue for heart failure management. It falls under the pharmacological classification of regenerative medicine, focusing on repairing or replacing damaged heart tissue.

Investigated diseases

Heart Failure – Heart failure is a condition where the heart is unable to pump blood effectively to meet the body's needs. It can result from various underlying heart conditions that weaken or damage the heart muscle. As the disease progresses, individuals may experience symptoms such as shortness of breath, fatigue, and swelling in the legs and ankles. The heart's reduced ability to pump blood can lead to fluid buildup in the lungs and other parts of the body. Over time, the heart may become enlarged, and its pumping efficiency may further decline. The condition can affect either the left side, right side, or both sides of the heart.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-515708-38-01Protocol code02289Estimated enrolment53 patientsSponsorUniversitaetsmedizin Goettingen

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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