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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 study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsmedizin Goettingen Goettingen Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany

Other Sites

Site Name City Country Status
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Utnlaclpdj Muvrptd Cqlpsc Hcumgwkfsgyfjdgln Hamburg Germany
Ubfywdqxdv Htogeoep Ctiqroc Cologne Germany
Ufoplkrhvbgopjsrhzmtk Dwmycnexhyr Axj Duesseldorf Germany
Kiuwethg dho Upomzplfttac Mydcrxvt Aqd Munich Germany

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

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
03.02.2021

Trial locations

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.

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 ID:
2024-515708-38-01
Protocol code:
02289
NCT ID:
NCT04396899
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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