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Nachrichten, Termine, Experten
Multi-million-euro funding from the European Union: Congenital heart defects often lead to heart failure. This means that even young patients require mechanical circulatory support or an organ transplant. Both severely impair quality of life. Heart muscle cells grown in the laboratory offer an alternative. If these cells come from the patients themselves, immunosuppression is not even necessary. However, the production process is complex and expensive. With the iNDUCARE project, an international research team led by the MHH now aims to improve a production process already approved in the USA so that personalised heart repair becomes affordable and clinically viable in the future.
Heart failure is one of the leading causes of death worldwide. Treatment options are limited, particularly when heart failure is caused by congenital heart defects. Those affected require mechanical circulatory support or an organ transplant as early as young adulthood. Both options have drawbacks: cardiac support systems require lifelong anticoagulation and are not a permanent solution; donor hearts are scarce and necessitate lifelong immunosuppression. The use of so-called human induced pluripotent stem cells (hiPSCs) offers an alternative. These genetically reprogrammed somatic cells can develop into any type of cell – for example, into heart muscle cells. Such laboratory-produced cardiomyocytes (hiCMs) are intended to replace lost heart muscle tissue and improve heart function in the future. If the hiPSCs are derived not from donated somatic cells but from the recipients themselves, immunosuppression is not even necessary. This is because the immune system does not recognise the cells derived from the body’s own, autologous hiPSCs as foreign. However, their production has so far been very complex and expensive.
A research team led by Prof. Dr Robert Zweigerdt, a cell biologist at the Leibniz Research Laboratories for Biotechnology and Artificial Organs (LEBAO) at the Department of Cardiac, Thoracic, Transplant and Vascular Surgery at Hannover Medical School (MHH), and LEBAO Director Professor Dr Ulrich Martin, aims to solve this problem. With their iNDUCARE project, they aim to utilise a manufacturing process for autologous hiCMs that is already approved in the USA and improve it so that personalised heart repair becomes affordable and clinically feasible in the future. The European Union is funding the international collaborative project with a total of eight million euros. As the coordinator, the MHH will receive around two million euros of this.
Immunosuppression is problematic
“A major advantage of transplanting hiCMs derived from the patient’s own, so-called autologous, blood cells is that no immunosuppression—which is associated with side effects—is required, which is a decisive advantage, particularly for children and young adults,” notes Professor Martin. From a commercial perspective, the mass production of cell products derived from non-patient-specific (allogeneic) iPS cells may appear attractive due to lower upfront costs compared to patient-specific iPSCs. However, this would result in significantly higher costs in the long term, as lifelong immunosuppression is generally required. Prof. Dr Arjang Ruhparwar, Director of Surgery at HTTG, adds: “Drug-induced immunosuppression is also problematic for patients in critical condition because their immune systems cannot tolerate any further impairment. But such treatment is also unjustifiable for children and young adults given the high risks of infection, tumour development and reduced quality of life.”
Production still too time-consuming and too expensive
In the long term, therefore, the autologous approach could in many cases prove even more cost-effective and sustainable than therapy using allogeneic iPSCs derived from a donor. However, in addition to the significantly higher costs at the start of treatment, there are two further reasons why this therapy has not yet become widely established. Firstly, each cell line must not only be created individually, but also produced and quality-assured through complex manufacturing processes to guarantee the desired function and rule out treatment risks. Secondly, for acute heart conditions, it takes too long to produce a sufficient quantity of these cells for treatment.
AI-supported quality control
The complex production processes are to be further improved in iNDUCARE. Newly developed sendavirus vectors are intended to shorten the reprogramming process and reduce costs. The researchers aim to tackle the second problem with the help of high-density stirred-tank bioreactors. “So far, the required cell numbers can only be produced in large two-litre bioreactors,” says Professor Zweigerdt. “AI is to be used to optimise production processes and quality control: we aim to produce a sufficient treatment dose in just 300 millilitres – roughly the volume of a large coffee mug.”
Using the platform for other applications as well
The researchers aim to compare the MHH’s current production processes with those already in use in the USA. Combining elements of both technologies is expected to result in an improved hiCMs production platform that can be used in both Europe and the USA for the manufacture of autologous iPS products. “We expect a five- to seven-fold increase in cardiomyocyte yield, whilst reducing production time from one year to seven months and cutting costs by up to 70 per cent,” explains Professor Zweigerdt. “And all this without compromising on safety or quality.” The researchers are not focusing solely on the heart muscle. “Our manufacturing platform is also intended to be transferable to other cell-based therapies and to lay the foundation for next-generation patient-specific treatments that go beyond heart repair,” emphasises Professor Martin.
The iNDUCARE collaborative project will start on 1 September 2026 and will run for four years. In addition to the MHH, cooperation partners from research, industry and clinical practice in Germany, the UK, Israel, the Netherlands, Switzerland, the Czech Republic and the USA are involved.
SERVICE:
For further information, please contact Prof. Dr Ulrich Martin, martin.ulrich@mh-hannover.de, or Prof. Dr Robert Zweigerdt, zweigerdt.robert@mh-hannover.de.
Smaller, but perfectly adequate: Prof. Dr Robert Zweigerdt and Prof. Dr Ulrich Martin present the ne ...
Copyright: Karin Kaiser/MHH
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Smaller, but perfectly adequate: Prof. Dr Robert Zweigerdt and Prof. Dr Ulrich Martin present the ne ...
Copyright: Karin Kaiser/MHH
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