The Team

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  will be

  • 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 Medical Center – University of Freiburg will be

  • One of the 4 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 Medical Center – University of Freiburg is part of the Albert Ludwigs University Freiburg and was recognized 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 preclinical studies with a focus on knee and shoulder surgery.

The Galeazzi Orthopaedic Institute will be

  • One of the 4 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 University of Zagreb’s School of Medicine working in collaboration with University Hospital Sveti Duh, the Veterinary Faculty and Faculty of Science, University of Zagreb will be

  • One of the 4 clinical sites
  • Be responsible for the pre-clinical study into the kissing lesions

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 Fraunhofer Institute (IGB) will be

• Responsible for the production and release of the grafts in compliance with regulatory guidelines

The Translational Centre Würzburg, branch of the Fraunhofer IGB, develops special solutions for cell-based test systems, processes, applications and (biologically vascularised) implants until prototype level. Within this frame, the Translational Centre lays its focus on contract research for biotechnologic, pharmaceutic and medical-technical companies and clinics, diagnostic laboratories as well as research facilities.

Within the business units Bioreactors, Testsystems, Theranostics, Implants and Regulatory Affairs the Translational Centre optimizes and creates processes, materials and products for regenerative therapies from pre-clinic to approval.

BIO-CHIP partner Fraunhofer IGB – Translational Centre Würzburg offers the knowledge and infrastructure for GMP conform implementation of guidelines and procedures which is an essential requirement for the manufacturing of advanced medicinal products. Appropriate standards, validated processes and complete documentation ensure safety and consistent quality during development and production as well as storage, packaging and transportation of the new BIO-CHIP medicinal products.

These competences strongly interlink Fraunhofer IGB – Translational Centre Würzburg with its partners and make BIO-CHIP a consortium offering new therapeutic options in the treatment of cartilage diseases.

Medacta will

  • Develop a dedicated My Clinical web-based database allowing the clinical data from the four clinical centres to be collected
  • Take the lead in addressing the financial and marketing issues required to commercialize the tissue engineered cartilage graft and will generate a market analysis and a business plan
  • Evaluate companies for future commercial or production purposes or interested in a phase 3 trial
  • Define a country specific reimbursement strategy

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) will provide

  • Coordinated operational services to support the clinical trial management at the 4 clinical sites, including on site monitoring
  • Support in the preparation of documents for the regulatory submission

 

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.