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Researchers at the University Medical Center Göttingen (UMG) and the University Hospital of Schleswig-Holstein (UKSH) have made a significant breakthrough in the treatment of severe heart failure: For the first time, a clinical trial has demonstrated that laboratory-grown heart muscle tissue can improve the pumping function of damaged hearts. The results were published in the New England Journal of Medicine. The study is part of a research program conducted by the German Center for Cardiovascular Research (DZHK). The development is also supported by the Göttingen-based biotechnology company Repairon GmbH.
+++ Joint press release with the University Hospital Schleswig-Holstein (UKSH), Lübeck Campus, and the German Centre for Cardiovascular Research (DZHK) +++
When Steffen Eyring suffered a severe heart attack in July 2020, the now 58-year-old was in a coma for several days. Although his condition initially stabilized after rehabilitation, his cardiac output remained severely impaired. Together with his wife, Ina, he tried to restructure their daily routine. The couple changed their diet and began taking regular walks to strengthen his heart.
“At first, we managed 30 minutes, then it took him 40 minutes to cover the same distance—and later even longer. He had to stop repeatedly and was struggling to breathe,” says Ina Eyring. “It was a gradual process.” The cause: severe heart failure.
Heart failure is one of the most common serious heart conditions worldwide. According to the German Heart Foundation, approximately four million people in Germany alone live with heart failure. The condition often develops as a result of a heart attack: parts of the heart muscle are no longer supplied with enough oxygen and suffer permanent damage. The body replaces the dead muscle tissue with scar tissue, which cannot contract. The result: the heart’s pumping power gradually declines. Despite modern medications, the disease continues to progress in many patients. In severe cases, heart transplants or mechanical cardiac assist devices have often been the only remaining treatment options.
Steffen Eyring’s heart function also continued to deteriorate despite the implantation of a defibrillator and other therapies. Eventually, his heart’s pumping capacity had dropped to only about 18 to 20 percent: he was recommended a mechanical cardiac assist device. “But using an artificial heart didn’t seem right to me,” says Eyring.
The couple learned about the heart patch study from a television report. “It was like winning the lottery,” says Eyring. “We saw the report and immediately thought: This might be my chance. I told my wife that I wanted to volunteer as a study participant.”
As part of the BioVAT-HF-DZHK20 study, conducted jointly by the University Medical Center Göttingen (UMG) and the University Medical Center Schleswig-Holstein (UKSH), University Heart Center Lübeck, under the scientific direction of Prof. Dr. Wolfram-Hubertus Zimmermann, Director of the Department of Pharmacology and Toxicology at UMG, a heart patch grown from stem cells is being investigated as a new therapeutic approach for patients with severe heart failure. The researchers have now achieved a significant breakthrough: For the first time, a clinical study has demonstrated that heart muscle tissue grown in the laboratory can stabilize damaged hearts, thereby improving both pumping function and symptoms in heart failure. The study is the world’s most comprehensive clinical investigation of a therapy based on pluripotent stem cells and, according to the researchers, is the first study in this field to demonstrate statistically significant clinical benefits in treated patients.
“The treatments available today can often slow the progression of the disease, but they cannot replace damaged heart muscle,” says Prof. Zimmermann. “Our goal is therefore to generate new, functional heart muscle tissue to provide targeted support to the weakened heart.”
The findings were published in the New England Journal of Medicine
Original publication:
Zimmermann W-H, Ensminger S, Kutschka I, et al. Stem-Cell–Derived Biologic Ventricular Assist Tissue in Heart Failure. New England Journal of Medicine (2026). DOI: 10.1056/NEJMoa2513525
For this therapy, the researchers use so-called induced pluripotent stem cells (iPS cells). These are produced in the laboratory from blood cells and then differentiated into cardiac muscle and connective tissue cells. Combined with collagen as a natural scaffold, this results in beating heart tissue. This artificial heart tissue is produced in special clean rooms at the UMG under the supervision of the Department of Transfusion Medicine. Up to 20 such tissue units are then assembled into a so-called heart patch.
The heart patch is sutured onto the outside of the damaged heart via a minimally invasive approach. There, the cultured tissue is intended to form a new layer of heart muscle, approximately three to four millimeters thick, designed to stabilize and provide long-term support to the weakened heart muscle.
In June 2024, Steffen Eyring will also undergo surgery at UMG. The family describes the medical care and communication as professional and clear. “We felt very well taken care of,” says Ina Eyring.
Results of the Clinical Trial
The BioVAT-HF-DZHK20 clinical trial has been conducted jointly by the UMG and the UKSH since early 2021. The artificial heart tissue required for the therapy is produced in special cleanrooms at the UMG with the support of experts from the Göttingen-based biotechnology company Repairon GmbH, a spin-off of the UMG. The aim of the study is to investigate the safety and efficacy of the cardiac patch in patients with severe heart failure.
A total of 20 patients with severe heart failure were treated in the current Phase 1/2 study. Despite comprehensive standard drug and device therapy, all treated patients suffered from severely impaired heart function at the time of study enrollment. In these patients, the so-called left ventricular ejection fraction—that is, the percentage of blood that the heart pumps from the left ventricle into the body with each beat—was at most 35 percent.
In the first phase of the study, the researchers investigated the maximum dose of cultured heart muscle tissue that could be safely transplanted. The result: approximately 800 million heart cells. The therapy was then tested on additional patients. An analysis of the first 16 individuals who received the highest safe dose showed thickening of the damaged heart wall three months after treatment. In addition, the heart’s pumping function improved, and patients reported a better quality of life. Even during the more than four years of follow-up of the treated patients, initial signs of sustained improvement in heart function were observed.
Two years ago, the first report was published about a patient who had been implanted with a cardiac patch and subsequently showed significant improvements in heart function. The results now published go well beyond that: systematic clinical data from a larger patient cohort are now available.
“Our results show for the first time in a larger clinical study that restoring heart muscle function in humans with advanced heart failure is fundamentally possible,” says Prof. Zimmermann. “This confirms important findings from our many years of research.”
Prof. Dr. Stephan Ensminger, Director of the Department of Cardiac and Thoracic Vascular Surgery at the University Heart Center Lübeck (UKSH) and Surgical Director of the BioVAT-HF-DZHK20 study at the UKSH, also views the results as a significant step forward: “After many years of research, we have now been able to demonstrate for the first time that heart muscle tissue grown from stem cells can be safely implanted in patients.”
Prof. Dr. Ingo Kutschka, former Director of the Department of Cardiac, Thoracic, and Vascular Surgery at the UMG and now Deputy Chief of Cardiac Surgery at the University Hospital Basel, emphasizes: “The heart patch could become an additional treatment option in the future for selected patients with severe heart failure.”
For Steffen Eyring, the treatment means, above all, greater stability in his daily life. Since the operation, his heart function has improved slightly and stabilized. “He can participate in daily life again and now has more good days than bad,” says Ina Eyring.
Further studies are needed
The researchers emphasize that the promising results of the interim analysis now published must be confirmed in further clinical trials. Follow-up studies involving additional centers in Germany, Europe, and the United States are already in the works.
Translational research from Göttingen
The study was preceded by more than 25 years of research. The production of the artificial heart tissue for use in the BioVAT-HF-DZHK20 study at UMG is supported both substantively and financially by Repairon GmbH, a spin-off of UMG. The study is part of the translational research program of the German Center for Cardiovascular Research (DZHK), which aims to translate research findings into clinical applications.
Prof. Dr. Wolfram-Hubertus Zimmermann, Department of für Pharmacology and Toxicology, Phone +49 551 / 39-65781, biovat.info@med.uni-goettingen.de
Zimmermann W-H, Ensminger S, Kutschka I, et al. Stem-Cell–Derived Biologic Ventricular Assist Tissue in Heart Failure. New England Journal of Medicine (2026). DOI: 10.1056/NEJMoa2513525
Significant progress in the treatment of severe heart failure: For the first time, a clinical trial ...
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Significant progress in the treatment of severe heart failure: For the first time, a clinical trial ...
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