Based in Strasbourg (France), the CeeD was created in 1991 by Professor Michel Pinget, current leader of the NUDE center and Department of Endocrinology, Diabetes and Metabolic Diseases at the University Hospital of Strasbourg (UHS). Structure of translational research, the CeeD combines physicians and researchers to respond via laboratory research to questions from health care teams and to patient’s.
BIOSID project coordinator, CeeD has extensive coordination experience through the 2 BARP European projects (4th FPRD) and BARP+ (6th FPRD) which gave rise to the current MAILPAN® bioartificial pancreas prototype. The BARP+ project was recognized as a “Success Story” by the European Commission. During these two projects, 3 patents protecting the MAILPAN® were filed and numerous scientific publications in international journals.
AvantiCell (ACS), a biotechnology SME, based in Scotland (UK), is specialized in cell culture technologies and in the formulation of culture environments depending on the type and needs of the cells, carrying out large scale analyzes. More specifically, the ACS’ expertise is based on the production of stem or primary cells of human origin, using proprietary technologies to mimic their physiological functions. In addition, ACS is specialized in the high-throughput screening of drug candidates on cells, for various therapeutic applications.
In BIOSID, ACS will work on making a culture medium meeting the needs of insulin-secreting cells in the bioartificial pancreas. Indeed, ACS will test different formulations of culture environments in order to choose that which will best optimize the survival and function of cells in the MAILPAN®. This work will be done in close collaboration with the project partners.
Coordinated by Professor Eric Renard, the Department of Endocrinology, Diabetes and Nutrition of the University Hospital Center (UHC) of Montpellier has over 20 years experience in optimizing therapy for type 1 diabetes. More specifically, this department contributes to a platform, called EVADIMM dedicated to the clinical trials of innovative medical devices for the treatment of diabetes (implantable and external pumps and the artificial pancreas). The UHC of Montpellier is also experienced in the isolation of human pancreatic islets and in the study of mechanisms involved in the survival of islets, before and after transplantation in humans.
In BIOSID, UHC of Montpellier will mainly focus on the following tasks:
conduction of a large part of the clinical studies of bioartificial pancreas in diabetic patients, with a focus on the study of the function, safety and tolerance of MAILPAN®,
isolation of human pancreatic islets from donors,
understanding the needs of insulin-secreting cells in the bioartificial pancreas, in partnership with the Institute of Functional Genomics (UMR CNRS 5203/INSERM U661/Universities of Montpellier 1&2), in order to improve the survival and function of these islets in the MAILPAN
The Nuffield Department of Surgical Sciences at the University of Oxford, including the team led by Professor Paul Johnson, is a pioneering center in the isolation and clinical transplantation of human pancreatic islets.
The research is divided into 11 themes among which transplantation is one of the most developed. Their work on the isolation of pancreatic islets began in the 80s, for applications in research, while clinical application began in the 90s. This department has access to unique facilities for the isolation of human pancreatic islets under GMP conditions, with transplantation success that exceeds 70% of transplant patients. NDS will work closely with the CeeD to understand the needs of insulin-secreting cells in the bioartificial pancreas and provide the answers necessary for their survival in it. In addition, this public department will intervene in the supply of MAILPAN® with human pancreatic islets for clinical trials and perform a part of these tests, at Oxford.
Spin-off of the CeeD, Defymed is a French SME specialized in the design and development of innovative bioartificial medical devices. Defymed is, first, focused on an application for the treatment of type 1 diabetes. The first product designed by Defymed is a bioartificial pancreas intended to be implanted in diabetic patients in order to restore normal and stable blood sugar levels in the latter. This device named MAILPAN (macro-encapsulation of pancreatic islets) is in the form of a pocket having functions of a bioartificial pancreas, which once implanted will be filled with insulin-secreting cells.
As owner of the bioartificial pancreas MAILPAN®, on which the BIOSID project is based, Defymed is responsible for manage the exploitation and dissemination of the BIOSID project. The team from the start-up will also investigate the biocompatibility and function of the MAILPAN device in preclinical phases in large animals and in clinical phases in humans, with a particular focus on the regulatory aspects related to these studies. Finally, Defymed will be responsible for the design and manufacture of MAILPAN® adapted to the model used (small or large animals and humans) for the BIOSID partners.
Endocells, a French biotechnology SME, is specialized in the development of technologies with the view of providing an unlimited source of human origin cells with endocrine properties possible. The first focus of Endocells concerns insulin-secreting cells in order to treat type 1 diabetes. Thanks to their unlimited availability, they are considered as good candidates for diabetes cell therapy. Directed by Prof. Paul Czernichow, Endocells counts among its team five engineers and scientists and works closely with the research teams from INSERM and CNRS.
In BIOSID, the Endocells team will work on the culture conditions of a human Beta cell line to understand its needs and improve its viability and function inside the MAILPAN® device. On one hand, Endocells will study the behavior and mortality of its cells in the preclinical phase and on the other hand, the effectiveness and safety of cells will be studied in animal models developed by the BIOSID partners
The laboratory of experimental surgery of the UCL in Brussels capitalizes on over 20 years experience in the field of transplantation (single cells and whole organs) and immunology in large animals. Directed by Professor Pierre Gianello, this laboratory is specialized in the encapsulation of insulin-secreting cells and in studying of this treatment in large animals. With an animal housing within a laboratory of an area over 600m2, it provides the best conditions and equipment for experimental surgery and monitoring of animal metabolism, as well as facilities for biological analysis and immunological monitoring.
The UCL team will intervene in the preclinical validation of the MAILPAN® device on large animals as well as the isolation of insulin-secreting cells of animal and human origin. The preclinical validation will include study of the function of MAILPAN® associated with different cells, its integration, immune responses within and around the device, in order to obtain permission to enter clinical trials, via the European regulatory authorities. UCL has developed its own large diabetic animal models which will be used for the implementation of the MAILPAN®.
Prof. Thierry Berney: a world authority on islet isolation, islet transplantation, and whole organ transplantation. Professor of Surgery, Department of Surgery, at the University of Geneva School of Medicine and an attending Surgeon in Visceral and Transplantation Surgery, Department of Surgery, at Geneva University Hospital. He is the director of Islet, Pancreas and Small Bowel Transplantation Programs, Department of Surgery, Geneva University Hospital and the director of Cell Isolation and Transplantation Center.
Prof. Bernhard Hering: a world opinion leader on islet xenotransplantation. Professor of Surgery and Medicine at the University of Minnesota, Minneapolis, scientific director of the Schulze Diabetes Institute, department of surgery at the University of Minnesota, Director of Islet Research and Transplantation Program at the University of Minnesota. He is President of the International Xenotransplantation Association (IXA).
Prof. Jean-Claude Henquin: head of the Endocrinology and Metabolism department of the UCL medical faculty and member of many prestigious associations in Diabetes. He is a world opinion leader in the study of insulin secretion by Beta cells. He is a specialist of the study of the mechanisms of the control of insulin secretion.
Prof. Joao Nabais: vice president of IDF Europe. He will intervene in the Ethics and Good Practice Committee (EGPC) of BIOSID. IDF Europe’s mission is to advance diabetes care, prevention and a cure in Europe. They are a diverse and inclusive multi-cultural network of national diabetes associations, and an authoritative European voice in non-communicable diseases. Their business is to ensure that the needs of all people affected by diabetes are met so they can live their lives unhindered by their condition. Their constituencies include people with diabetes, people at risk of diabetes, their families, health professionals, representatives of industry, education and research institutions, and the wider European community.