Globally, one out of 100 children is born with a heart defect. In some severe cases, a heart valve or blood vessel functions poorly or may even be missing.
Such congenital heart defects are commonly treated today by replacing the missing or damaged part with synthetic prosthetic materials. Unlike direct transplant of tissue from human donors, such artificial materials are not rejected by the recipient's immune system. However, a major drawback of these materials is that these grafts need to be replaced regularly as the child grows, thus requiring repeated surgery and lifelong medical treatment.
A multidisciplinary team from Wyss Zurich has developed a unique tissue engineering technology to grow replacement tissue in the laboratory, which will be compatible with every patient, regenerate and grow with the recipient. To create this tissue, cells of human origin are first grown in culture on a scaffold in the shape of a heart valve or blood vessel. In a process called decellularization, the cells are then removed, leaving behind a perfectly shaped, biologically neutral human tissue matrix called LifeMatrix. After implantation, the recipient's own cells will repopulate the LifeMatrix, replacing the biodegradable scaffold; and this tissue will continue to grow with the child. Such grafts will avoid repeated major surgery and its associated risks.
Previous work on autologous and personalized cellular tissues (patient receives tissue grown from his own body), which already obtained approval for a pilot clinical study by the German authority (PEI), is the basis for this next generation tissue engineering technology. The aim of the Wyss Zurich project is to bring the LifeMatrix technology into the clinic with a first-in-man clinical trial.
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Swiss Higher Education Council
University Hospital Zurich
Empa - Materials Science and Technology
Learn more about LifeMatrix on the website www.lifematrixtechnologies.com
Maximilian Y. Emmert
Maximilian Y. Emmert is a cardiac surgeon and translational scientist with extensive clinical and academic experience. He has more than 10 years of research experience in the fields of regenerative medicine, stem cell therapies, and cardiovascular tissue engineering. Maximilian is a full professor and the Director of Cardiosurgical Research at Charite University Medicine, Berlin, a senior physician at the German Heart Center Berlin, and a research scholar at the Wyss Institute of Biologically Inspired Engineering in Boston. He also holds a professorship for Translational Cardiac Surgery at the Institute for Regenerative Medicine (IREM), University of Zurich. He obtained his PhD in Biomedical Engineering from the Technical University Eindhoven, in 2013, focusing on "Translational therapies to repair the heart".
For his work, he has been awarded the prestigious Pfizer Prize from the Pfizer Research Foundation, the Innovation Award of the European Association of Cardiothoracic Surgery (EACTS), and the renowned Siegenthaler Award from the University of Zurich.
Nino Jejelava is a multidisciplinary mind with more than 15 year of research experience in the areas of computational simulation of physical processes, bioengineering and biotechnologies. Nino initially started within the LifeMatrix team in the role of Regulatory Affairs/Quality Management to support the transition of LifeMatrix technology from R&D set up to clinical trial application submission. Afterwards, she evolved into Process Engineer/GMP Scientist and extensively collaborated with the Wyss Zurich Regenerative Medicine Technologies Platform to implement the GMP and ISO 13485-quality management system for the LifeMatrix project. Her solution driven approach to design and structure processes together with effective communication skills and strategic vision to anticipate, prevent, and solve complex problems in multidisciplinary, international work environments has earned her a role as Project Leader within the LifeMatrix team as of June 2022. In her new role together with the team, Nino is dedicated to bring to the market a unique LifeMatrix bioengineering technology to grow human replacement tissues, as next generation implants for the treatment of cardiovascular diseases. Nino earned a PhD in Neuroscience from ETH Zurich, a MSc in Bioengineering with specialization in Biotechnology from EPF Lausanne, and a BSc in Physics from Tbilisi State University. Her latest article was named to the American Physiological Society’s APSselect list, which recognizes the best recent publications in physiology.
Quality and Risk Manager
Brigitte Angst joined the LifeMatrix team in January 2016. Assisting with quality management and quality control matters, Brigitte supports the translation of LifeMatrix production processes within a fully GMP-compliant environment. Furthermore, she collaborates with the Wyss Zurich Regenerative Medicine Platform to implement the ISO 13485 quality management system for the LifeMatrix project. Brigitte studied biochemistry at ETH Zurich. In 2012, she received her PhD in molecular biology at the Institute of Molecular Biology and Biophysics (ETH Zurich), where she worked towards the structural elucidation of the ATP-dependent chromatin remodeling process.
GMP Production Operator
Matthias Meier joined the LifeMatrix team in June 2016. He is responsible for the GMP-compliant production of the tissue-engineered constructs as well as the development and improvement of the LifeMatrix technology. Matthias was trained as a Biology Technician (EFZ, “Eidgenössischer Fähigkeitsausweis”) at Novartis; and he holds a Bachelor’s degree in Biotechnology from the ZHAW Zurich University of Applied Sciences. He has several years of experience in the field of cardiovascular tissue engineering as well as extensive cell culture expertise in both, industrial and academic settings. Matthias previously worked in various organizations, including the University Children’s Hospital in Zurich, the University of Bern, as well as Symetis AG, Redbiotec AG and Redvax GmbH.
GMP Production Operator
Loretta Miani joined the LifeMatrix team in July 2021. She is responsible for the GMP-compliant production of the tissue-engineered constructs as well as the continuous development and improvement of the LifeMatrix Technology. Before joining LifeMatrix, Loretta worked at the Cell and Tissue Biobank (CTBB) Department at Wyss Zurich where she was responsible for the freezing and storage of cryogenic material, organizing the database and maintaining equipment and documents in accordance with GMP. Loretta holds a Bachelor of Science degree in Biotechnology (2017). After graduation, she worked for the pharmaceutical company Streuli Pharma AG, where she gained experience in a GMP-relevant environment and in quality assurance and production. As head of a clean room division, she was responsible for coordinating sterile production processes, supervising employees and carrying out project work.
Clinical Trial Manager
Michael Stader joined the LifeMatrix team at Wyss Zurich in April 2018. He is responsible for the management and coordination of the clinical trials developed within the LifeMatrix project. After a professional training as nurse and subsequent work in a central operating theatre, Michael has spent the last 11 years in the clinical trial sector. He gathered comprehensive experience in the conduction of clinical trials as Clinical Research Associate for medical device studies at St. Jude Medical and as Study Coordinator at University Hospital Zurich (Department for Cardiovascular Surgery), where he was responsible for the coordination and conduct of sponsored as well as investigator-initiated trials.
René Stenger is the Technology Expert for production of tissue-engineered matrices. As a chemist with a postgraduate “Diplom” in Medicine-Technology-Management (Bern University of Applied Sciences), he has long lasting experience in the highly regulated industrial environment of medical devices and pharmaceuticals. In his former positions in several spin-off companies, as well as the Swiss Center for Regenerative Medicine of the University Hospital Zurich, he accompanied various translational projects in the field of regenerative medicine, e.g. a First-In-Man clinical study to evaluate the safety of autologous tissue-engineered dermal and dermal-epidermal skin substitutes for the treatment of large deep partial- and full-thickness skin defects in Children and Adolescent (University Children’s Hospital Zurich) and an open, monocentric phase I/II trial to assess the safety and feasibility of the autologous SCRM001_TEVG in pediatric patients with a congenital single ventricle heart defect.