A new approach for treating severe heart failure, known as heart insufficiency, has been developed by a team led by Wolfram-Hubertus Zimmermann at the University Medical Center Göttingen. This method utilizes induced pluripotent stem cells (iPS), which can be generated from mature body cells and can differentiate into various cell types, including heart muscle tissue.
The heart patch, approximately 100 square centimeters in size, is created from iPS cells and contains both heart muscle cells and connective tissue cells. Zimmermann states that the production process takes about three months. The implant is designed to be applied to the weakened heart muscle, potentially enhancing its pumping capacity.
Initial tests on rats and rhesus monkeys over a period of three to six months indicated that the implants, consisting of 40 to 200 million heart cells, could improve heart function. Following these preclinical results, the Paul-Ehrlich-Institut approved the first human trials of the heart patch.
In a study published in Nature, the case of a 46-year-old woman with advanced heart failure, alongside conditions such as type 2 diabetes and hypertension, was discussed. After receiving the heart patch, her left ventricle's pumping efficiency increased from 35% to 39% over three months. This marked the first evidence that heart muscle repair through regeneration is possible in humans.
Currently, 15 patients have received the heart patch, with a total of 53 planned for the study. Initial clinical data is expected by the end of 2025. Although the patch is intended to bridge the time until a heart transplant is available, Zimmermann suggests it could also serve as a permanent solution.
Patients must take immunosuppressants post-procedure; however, no significant side effects or increased tumor risks have been observed. The cells used to create the iPS cells were not sourced from the patients themselves due to logistical challenges and potential rejection reactions.
Approximately one in ten individuals with heart failure, equating to about 200,000 people in Germany, could be eligible for this therapy. A regulatory study may begin as early as 2026, with applications for special permissions to treat additional patients before official approval underway. This stem cell-based approach may also hold potential for treating other conditions, including Parkinson's disease and age-related macular degeneration.