The BIO-CHIP team brings together university hospitals, research institutes and industry with distinct expertise in the fields of biology, bioengineering, medicine, regulatory affairs and business. Our clinicians are internationally known experts in cartilage repair and have extensive experience in research and clinical trials. Our research institutes and companies are experienced in the production of Advanced Therapy Medicinal Products (ATMPs) and the distribution of medical devices.
The University Hospital Basel is
- the leading centre and Sponsor for the multicentre-clinical study responsible for obtaining ethical approval, recruiting patients, performing pre-operative diagnosis (physical examination, x-ray, MRI), surgery, follow-up, and post-operative evaluation of the patients (functional tests, imaging);
- responsible for the biological issues as well as the essential development of processes, release and quality criteria for the manufactured grafts.
The Laboratory of Tissue Engineering belongs to the Department of Biomedicine in the University Hospital Basel which ensures close interaction between laboratory and clinical applications. The core competence of the multidisciplinary group lies in stem cell and chondrocyte biology as well as in the engineering of cellular grafts based on autologous cells and porous 3D scaffolds to repair cartilage and bone tissues.
The key personnel in the project are Prof. Dr. Marcel Jakob as PI (Chefarzt Orthopädie und Traumatologie), Dr Marcus Mumme (Oberarzt Knieteam, Spezialist für regenerative Kniechirurgie und Koordinator der Knorpelstudien) together with Prof. Dr. Ivan Martin (Forschungsgruppenleiter Tissue Engineering, Experte auf dem Gebiet der Gewebezüchtung und Knorpelbiologie and Project Coordinator). Patients are being actively recruited.
The Medical Centre – University of Freiburg, Germany is
- one of the 5 clinical sites responsible for obtaining ethical approval, recruiting patients, performing pre-operative diagnosis (physical examination, x-ray, MRI), surgery, follow-up, and post-operative evaluation of the patients (functional tests, imaging). Patients are being actively recruited.
The Medical Center – University of Freiburg is part of the Albert Ludwigs University Freiburg and was recognised in 2007 as one of five outstanding centres of academic excellence in Germany. Its Department of Orthopaedics and Trauma Surgery, established in 1970 is one of the oldest in Germany and since 2010 has collaborated closely with the Clinical Trials Unit of the University. The clinic has 120 patient beds, treats approx. 25,000 patients on an out-patient basis and performs about 6,000 operations a year. The Department takes part in all kind of clinical and pre-clinical studies with a focus on knee and shoulder surgery.
The Galeazzi Orthopaedic Institute, Milan, Italy is
- One of the clinical sites responsible for obtaining ethical approval, recruiting patients, performing pre-operative diagnosis (physical examination, x-ray, MRI), surgery, follow-up, and post-operative evaluation of the patients (functional tests, imaging).
The University Department of Regenerative and Reconstructive Orthopaedics is part of the Galeazzi Orthopaedic Institute (IOG). IOG is a research hospital with accreditation by the Italian Ministry of Health as a “Scientific Institute for Research, Hospitalisation and Health Care” in the area of musculoskeletal diseases and associated pathologies, ensuring tight interaction between laboratories and the clinic. The core expertise of the department is reconstructive joint surgery with a special interest in novel regenerative procedures for cartilage. IOG is one of the 14 members of the International Society of Orthopaedic Centres collaborating with enterprises, research centres and universities to bring to completion research projects and experimental developments.
The team, led by Prof. Giuseppe Peretti and supported by Drs. Corrado Sosio and Laura Mangiavini. These surgeons are now recruiting patients.
- one of the clinical sites, (patients are currently being recruited) and with
- responsibility for the pre-clinical study into the kissing lesions.
The team is led by Ass. Prof. Alan Ivkovic, MD, PhD
Founded in 1917, the University of Zagreb’s School of Medicine is the oldest educational institution for medical training and research in South-East Europe and has an international reputation for excellence. In its determination to raise the standards of medical education and introduce a new culture of teaching, the school joined the growing number of medical schools in Central and Eastern Europe offering undergraduate and postgraduate programs in English. The School encourages its faculty to participate in international research, particularly in basic and clinical neuroscience, regenerative medicine, molecular biology, pharmacogenomics, diagnostic ultrasound, transplantation medicine, haematological malignancies, congenital metabolic diseases, clinical endocrinology and diabetes, public health and environmental medicine.
The chair for Orthopaedics within the Julius-Maximilians University of Würzburg is located at the Orthopaedic Hospital König Ludwig Haus. Both the section for Sports Orthopaedics and Reconstructive Knee Surgery (Dr. Barthel, Dr. Reppenhagen) as well as the Clinical Trial Unit (Dr. Seefried) are hosted here.
- The König Ludwig Haus joined the Consortium in July 2018 as the fifth clinical site and is now recruiting patients, performing pre-operative diagnosis (physical examination, x-ray, MRI), surgery, follow-up, and post-operative evaluation (functional tests, imaging).
The section for Sports Orthopaedics is a trans-regional reference centre for knee surgery specifically focused on reconstructive and regenerative procedures and is renowned for its high level expertise in regenerative knee surgery.
Within the Fraunhofer-Gesellschaft two Institutes are participating in the project, the Fraunhofer Institute for Silicate Research (Fraunhofer ISC) through its division Fraunhofer Translational Centre Regenerative Therapies (TLZ-RT) and the Fraunhofer Institute for Integrated Circuits (Fraunhofer IIS) through its division Magnetic Resonance and X-ray Imaging.
The TLZ-RT, Würzburg Division, is headed by Prof. Heike Walles with PD Dr. Oliver Pullig (group manager of the unit “Implants-GMP” and TLZ-RT Vice Director) as primary Consortium representative of the represented on the Consortium. The Institute is
- responsible for the production and release of the grafts in compliance with regulatory guidelines.
The Fraunhofer Translational Center Regenerative Therapies develops new cell-based tissue models and test systems, scalable production processes and biological vascularized implants right through to prototype. Thus, the TLZ-RT not only supports the rapid and cost-efficient development of medicines but also contributes to the implementation of the 3R principle.
The Magnetic Resonance and X-ray Imaging Department of the Fraunhofer IIS (Institute for Integrated Circuits) possesses extensive expertise in the development and application of MRI and MR spectroscopy experiments, and development of MRI hardware. Under the care of Dr. Daniel Haddad, Fraunhofer IIS is
- responsible for carrying out the MRI of patients from the clinical site at Bayerische Julius-Maximilians-Universität Würzburg.
- responsible for the dedicated MyClinicalData web-based database recording, processing and storing patient data;
- taking the lead in addressing the financial and marketing issues required to commercialise the tissue engineered cartilage graft and will generate a market analysis and a business plan, including the
- evaluation of companies for future commercial or production purposes or interested in a phase 3 trial and
- defining a country specific reimbursement strategy.
The team is led by Dr. Angelo De Lollis, with Matteo Parravicini addressing the commercial issues and Stefano Biguzzi as contact for the trial database.
Medacta International S.A. is a family-owned company founded in 2000 and established in Castel san Pietro (Ticino, Switzerland) developing, manufacturing and distributing orthopaedic and neurosurgical medical devices worldwide. Its core strengths are the orthopaedic implants for hip, knee and spine as well as equipment enabling anterior minimal invasive surgical implantation (AMIS) and patient matched technologies (MyHip, My-Knee and MySpine). Medacta has established multinational partnerships for global marketing and distribution plus has extensive experience in data management and statistical analysis of clinical trial data.
The European Clinical Research Infrastructure Network (ECRIN-ERIC) provides
- coordinated operational services to support the trial management at the clinical sites, including on site monitoring.
The Consortium’s key contact is Dr. Caecilia Schmid, who is based in Bern at the Swiss Clinical Trial Organisation.
The European Clinical Research Infrastructure Network (ECRIN-ERIC) is a sustainable, not-for-profit, distributed infrastructure providing operational, coordinated services in the conduct of multinational clinical research projects in Europe. It is based on the connection of national networks of clinical research centres and clinical trials units. ECRIN-ERIC has a legal status as “ERIC” (European Research Infrastructure Consortium) and its sustainability is secured by the contribution of its Member countries.