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.
Robin Müller joined the LifeMatrix team at Wyss Zurich in January 2019. He is in charge of coordinating and structuring workflows and ensuring accurate reporting and resource allocation. Robin is also responsible for operational support for the multidisciplinary team as it moves forward in completing the various project tasks. He holds a BA in political science and economics from the University of Zurich. Robin founded KLAR Koffeinwasser in cooperation with the ETH spin-off Highperformance Group, where he oversaw the implementation and optimization of marketing and sales campaigns. He previously gained experience as Project Manager and Business Developer for an international consulting group, where he formed a team of consultants to advise medical device companies on compliance and regulatory issues.
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.
Process Engineer and R&D
Nino Jejelava joined Wyss Zurich in November 2018. She initially worked in Regulatory Affairs/Quality Management and later as a Medical Device Development Engineer. Nino provides support for project research and development activities, as well as production process translation within a fully GMP-compliant environment. She has a multidisciplinary background with over 15 years of research experience in the areas of computational simulations, functional proteomics, primary cell cultures, virus production and animal studies. 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.
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.
R&D and Translational Scientist
Sarah Motta joined the LifeMatrix team at Wyss Zurich in March 2020 as an R&D and translational scientist. She holds a PhD in Cardiovascular Tissue Engineering and Regenerative Medicine from the University of Zurich, where her main focus was on the preclinical validation of tissue-engineered heart valves suitable for minimally-invasive applications. Additionally, in collaboration with the Swiss Federal School of Technology (ETH), she was involved in the Zurich Heart project, which aimed at the improvement of contemporary clinical assist devices, by means of new engineering and biological strategies. Since 2018, Sarah is appointed as Research Associate at the Disease Biophysics Group at Harvard University as well as at the Institute for Regenerative Medicine at the University of Zurich. Her research focus is on the development of tissue-engineered heart valves for aortic applications.
Quality/ Medical Device Engineer
Roberto Robledillo holds two master’s degrees, one in Industrial Engineering from the Polytechnic University of Madrid (2000), and one in Chemical & Process Engineering from the TU Wien (2000). He starts his career in Pharma, where he is introduced to the GMP environment, about which he has never stopped caring ever since. He also uses this time to learn the basics of manufacturing, validation, and quality assurance in a regulated environment. Later on, Roberto continues his development in the field of quality management, being part of various quality-oriented projects in the medical device area, and becoming close friends with the ISO 13485 and, more recently, the MDR. He has joined LifeMatrix in June 2020 and will be supporting the LifeMatrix team in a variety of topics as a Quality/ Medical Engineer.
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.