Bioengineered Heart Patch Improves Cardiac Function in Advanced Heart Failure

Severe heart failure occurs when damaged heart muscle can no longer generate adequate cardiac output, leaving patients symptomatic and at high risk despite modern therapies. Advanced cases often progress to the point where transplantation or mechanical support are the only remaining options. Clinicians need restorative strategies that replace lost myocardium rather than only slow decline. To help address this challenge, investigators have tested a lab‑grown heart muscle patch in a clinical study of patients with advanced disease.

University Medical Center Göttingen (UMG; Göttingen, Germany), in collaboration with the University Hospital Schleswig‑Holstein (UKSH; Kiel, Germany), developed a bioengineered cardiac patch constructed from induced pluripotent stem cells. The cells are generated from blood, differentiated into cardiac muscle and connective tissue cells, and combined with collagen as a scaffold to create beating tissue. Up to 20 tissue units are assembled into a patch that is surgically sutured onto the outside of the damaged heart through a minimally invasive approach.

The implanted construct is intended to form a new myocardial layer approximately three to four millimeters thick. The objective is to stabilize the ventricle and provide long‑term support to the weakened heart muscle. Manufacture occurs in UMG cleanrooms with support from Repairon GmbH, a Göttingen‑based biotechnology company that originated as a UMG spin‑off.

The Phase I/II BioVAT‑HF‑DZHK20 study enrolled 20 patients with severe heart failure who remained markedly impaired despite comprehensive standard drug and device therapy. All participants had a left‑ventricular ejection fraction of 35% or less at enrollment. A dose‑escalation phase identified approximately 800 million heart cells as the highest safe dose for transplantation. Among the first 16 recipients treated at this dose, the damaged heart wall thickened by three months, pumping function improved, and patients reported better quality of life. Over more than four years of follow‑up among treated patients, initial signs of sustained improvement in heart function were observed.

The work, conducted with the University Heart Center Lübeck at UKSH and within the German Center for Cardiovascular Research program, was published in The New England Journal of Medicine in 2026 under the title “Stem‑Cell–Derived Biologic Ventricular Assist Tissue in Heart Failure.” Further multicenter studies in Germany, Europe, and the United States are planned to confirm safety and efficacy. According to the investigators, the heart patch could become an additional treatment option in the future for selected patients with severe heart failure.

"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. This confirms important findings from our many years of research," said Prof. Dr. Wolfram-Hubertus Zimmermann, Director of the Department of Pharmacology and Toxicology at UMG.

Related Links
University Hospital Schleswig‑Holstein
University Medical Center Göttingen