The currently available treatments entail various complications and provide only short-term relief. Tissue engineering using autologous cells, which offers a feasible alternative for functional restoration of the damaged urinary sphincter muscle, represents an ideal treatment option that could reverse the underlying pathologic conditions.
MUS.I.C. is seeking to translate basic knowledge of Regenerative Medicine (RM) and stem cell therapy into clinical practice by undertaking a first-in-man study using autologous muscle precursor cells (MPCs), combined with neuromuscular electromagnetic stimulation (NMES), in 40 female patients. The project's aim is to perform the tasks required to show the safety and efficacy of the proposed novel multilevel treatment and to demonstrate the reproducibility of the therapeutic effect. Additional objectives are the optimization of the advanced-therapy medicinal product (ATMP), in order to achieve totally xeno-free and facilitated manufacturing, as well as the introduction of a novel injection technique for more efficient and precise implantation of the final product.
This project is supported by EU Horizon 2020 and Wyss Zurich.
Learn more about MUS.I.C. on the Website www.music2020.ch.
PROJECT PARTNERS in the EU Horizon 2020 are:
Scinus Cell Expansion TM
University of Tübingen
Paracelsus Medical University
Clinical Project Manager and Coordinator (Project Leader)
Deana Mohr (Haralampieva) joined Wyss Zurich in October 2018 and the Associate project MUS.I.C. from its very beginning, supporting Prof. Eberli in building up an international consortium and preparing a Horizon2020 grant proposal for assuring the funding for the translation of the project from bench-to-bedside. Deana acts as a Clinical Project Manager and Coordinator and is leading the synchronization of efforts of cross-functional project teams to support timely milestone achievements, and to manage study issues and obstacles, complying with GCP and GMP regulations. Before that, Deana obtained her MSc in Cellular and Molecular Biology from the University of Constance, Germany (2011). Afterwards, she joined the Integrative Molecular Medicine program in Zurich as a PhD student and successfully graduated at the ETH in Radiopharmaceutical Sciences (2015). The results of her PhD thesis were the final step before the authorization of the muscle tissue-engineering project for clinical translation and motivated her to proceed with a further education in clinical trial management.
Anka Baltensperger joined Wyss Zurich in October 2018 and the Associate project MUS.I.C. in March 2018. She is responsible for the administrative study coordination and the data management. Anka is trained as biomedical analyst and has both a Master of Arts from the University of Zurich and a Master of Public Health from the Universities Basel, Bern and Zurich. She worked several years as administrative study and project coordinator. With her background, Anka now supports the MUS.I.C. team in maintaining the quality management system (QMS) according to the local legal requirements of Good Clinical Practice and ensuring timely data collection.
Principle Investigator & Mentor
Daniel Eberli, MD, PhD, is Senior Attending Physician at the Department of Urology (University Hospital Zurich) since 2011. Due to his continued research in the field of Regenerative Medicine for over 14 years, he received his “professor ad personam” in 2017 and holds the chair for “Regenerative Urology”. Daniel Eberli graduated medical school at the University of Zurich (1997) and continued his education with a molecular medicine PhD program at Wake Forest University (2007), where he worked on techniques to bioengineer a functional sphincter muscle. Back in Switzerland, he built a Laboratory for Stem Cell Therapy and Tissue Engineering (2008) and continued the research by expanding the application fields. Daniel Eberli habilitated at the department of Urology (USZ), doing research on “Adult stem cells of Tissue Engineering of urinary Sphincter and Bladder” (2011). Throughout his career he obtained a number of competitive grants supporting his novel research. Evaluated on the basis of the criteria “excellence, impact and quality and efficiency of implementation”, his research efforts were funded by the prestigious EU H2020 program for translating the know-how from bench to bedside. Having the experience in the field of Regenerative Medicine and Tissue Engineering, Daniel Eberli is now expanding his career achievements by being the Principal Investigator (PI) and Mentor of the Associate project MUS.I.C. As a Sponsor-Investigator of the clinical trial, he is directly responsible for the GCP-compliant implementation of the first-in-man ATMP study for applying the muscle precursor cells into patients.
Head of GMP Production
Jenny Prange joined Wyss Zurich in October 2018 and the Associate project MUS.I.C. in February 2017 as Head of GMP Production and the Tissue Engineering laboratory of the Urology research team of the University of Zurich and USZ. Since then, she completed various GMP and GCP trainings and is responsible for the set-up and processing of the GMP-compliant production of muscle precursor cells for the clinical trial to treat stress urinary incontinence in the Horizon 2020 funded MUS.I.C. project. Jenny received her Diplôme d’Ingénieure in Biotechnology from the Ecole supérieure de Biotechnologie de Strasbourg and in parallel got a Master degree in Biotechnology and Therapeutic Innovation from the University of Strasbourg (2011). For her master thesis, she joined the Novartis Institutes for Biomedical Research in Boston, MA. Jenny obtained her PhD in Integrative Molecular Medicine from the University of Zurich (2016) and expanded further her knowledge in stem cell research at Roche Pharma Research and Early Development in Basel.
Co-Investigator Clinical Trial
Florian Schmid joined Wyss Zurich in October 2018 and the Associate project MUS.I.C. in the autumn of 2016, becoming an active member as Co-Investigator of the clinical trial. Florian is responsible for the clinical part of the study with inclusion, treatment and follow-up of the patients. Furthermore, he has joined the GMP-production team, for gaining deeper insight into all handling procedures. Florian is a medical doctor working in the Department of Urology at the University Hospital Zurich (USZ). He completed his medical school education at the University of Zurich (UZH) in 2013 and obtained his MD thesis at the UZH in 2016. He expanded his medical career with surgical rotations in thoracic, cardiac, visceral and traumatologic surgery departments at the USZ, before he started his further education as a resident in urology. In his academic career, Florian has published several original articles as first author, some of which broached the issue of organ transplantation and rejection. In spring 2018, Florian has started a PhD program in Clinical Science at UZH and is currently employed 80% as clinical scientist and 20% as urologist for the next three years.
GMP Production Technician
Rosa Sousa joined Wyss Zurich in October 2018 and the Associate project MUS.I.C. in September 2017 as a GMP Production Technician. Together with the production team, she is responsible for the GMP-compliant validation and for-patient-processing of the muscle precursor cells for the first-in-man clinical trial. Before joining the MUS.I.C. team, Rosa received her Master degree in Molecular and Cellular Biology in 2008. In the same year, she joined the Cytogenetics Laboratory in Porto University, Portugal, where she collaborated with six different research teams, gaining insight into multi-disciplinary research approaches. During these nine years, she specialized in karyotyping, lymphocytes and skin cell cultures for chromosome instability tests and bone marrow cell cultures for the diagnosis of blood cancer diseases. With her wide-range background, Rosa is contributing with vital inputs into the project and is now fully supporting the team, focusing on muscle tissue engineering.