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
Maximilian 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 tissue engineering. Since 2008, Maximilian is working in the Clinic for Cardiovascular Surgery at the University Hospital Zurich and in the Regenerative Medicine Program (REMEDI) at the University of Zurich. In 2009, he was awarded a scholarship by the Swiss National Science Foundation, “Special Program University Medicine” to conduct a project on “Advanced cardiac cell therapies”. Maximilian was also awarded the Pfizer Research Prize and the Annual Award of the Swiss Cardiac Surgery Society in 2012. In the same year, he obtained his habilitation in minimally-invasive, transcatheter tissue engineered heart valve therapies from the University of Zurich; and received his PhD in Biomedical Engineering focusing on "Translational therapies to repair the heart" from the Eindhoven University of Technology a year later.
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 Technician
Daniela Bukatz joined the LiveMatrix team at the Wyss Zurich in October 2017. Together with the other technicians, she is responsible for the GMP production of the tissue-engineered constructs in the Wyss Zurich clean room facility. Daniela was trained as Biology Lab Technician at the “Chemieschule Göttingen” in 1997. For the past 14 years she has gathered extensive experience in cell and molecular biology working for different research groups at Max Planck Institute for Experimental Medicine in Göttingen, University Hospital Freiburg im Breisgau, University Zurich and at the ZHAW Zurich University of Applied Sciences.
Head of Regulatory Affairs
Nancy Falla joined the LifeMatrix team at Wyss Zurich in September 2018. She is leading the regulatory operations and strategy for the project. Nancy has over 20 years of experience in international regulatory affairs for drugs, biologics, and medical devices. Nancy’s experience encompasses wide aspects of regulatory affairs including product development, registration and life-cycle management, strategic planning, liaison with health authorities (FDA, NCA, EMA, notified bodies …), submissions and compliance. In her career, Nancy namely accompanied various translational projects to first-in-man clinical studies. She previously worked in large and small organizations, including Serono, Kuros Biosurgery and CSL Behring. Nancy holds a PhD in Biology (stem cells) from the University of Antwerp, Belgium.
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 Technician
Tim Kästner joined the LiveMatrix team at Wyss Zurich in May 2018. He is responsible for the GMP production and development of novel tissue-engineered constructs in the clean room facility at Wyss Zurich. Tim was trained as Biotechnology Lab Technician in 2008. He already developed several assays for the pre-clinical and clinical phase at Covagen AG, a former ETH Spin-Off, which was acquired by Janssen Pharmaceuticals in 2014. After a travel in 2015, he started in Sales, selling microscopes for Nikon Switzerland AG. After two years as sales representative, he decided to move back into scientific environment.
Regulatory Affairs and R&D
Valentina Lintas joined the LifeMatrix team at Wyss Zurich in September 2018. She contributes to the development and implementation of the Regulatory Strategy for the LifeMatrix products. Additionally, leveraging on her background, Valentina is involved in advancing R&D and IP strategies of the LifeMatrix product portfolio. After receiving her MSc in Biomedical Engineering from Politecnico di Milano in 2014, Valentina completed her PhD at the Institute for Regenerative Medicine (University of Zurich). As a research assistant in the Tissue Engineering and Organoid Technologies Group, she developed regenerative tissue engineered minimally-invasive aortic valves, and participated in several collaborative, multidisciplinary projects on cardiovascular tissue engineering.
GMP Production Technician
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.
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.
Jason Schense joined the LifeMatrix team in January 2019. He oversees all business development activities related to the project. Jason has over 20 years of experience in the Pharmaceutical and Medtech industries. He was one of the original founders of Kuros Biosurgery. He also co-founded Astra Healthcare Advisers and currently serves as its director. Jason has significant management experience in both small and medium-sized companies. Throughout his career, Jason has been involved in all aspects of research and development while also establishing and managing key corporate partnerships. Through this work, he has brought products into late stage clinical development and registration, including a class III medical device. Jason holds Master’s and PhD degrees from Caltech and a Bachelor’s degree from MIT.
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.