The Bioartificial pancreas & cell confinement

Primordial to guarantee long term cell survival and function.

Partners

Centre européen d’étude du Diabète (CeeD)

Presentation

logo_ceedThe Centre européen d’étude du Diabète (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 expectations.

Its main objectives are to:

Role in the project

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.

The CeeD has all the assets required to complete this project. In addition to coordinating the project, through Dr. Séverine Sigrist, the CeeD will work on understanding the needs of the islets in terms of viability and function.  Thus, the CeeD will mobilize research teams in order to study the behavior of islets in the MAILPAN®, and this on animal models developed internally.


AvantiCell

Presentation

logo_avanticellAvantiCell (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.

Role in the project

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. ACS also has a facility, through its extensive network of experts, of producing large-scale culture environments and under GMP conditions (Good Manufacturing Practices).

ACS participates in numerous European programs uniting many partners and this is a major asset for BIOSID.


The CHU of Montpellier

Presentation

logo_chruCoordinated by Professor Eric Renard, the Department of Endocrinology, Diabetes and Nutrition of the University Hospital Center (CHU) of Montpelier 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 CHU 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. The CHU of Montpellier has participated from 2003 in the GRAGIL network (Rhine-Rhone-Alps Geneva Group for the transplantation of islets of Langerhans). The CHU has been involved in several European programs (7th FPRD and others) and its experience in the conduct of such projects is a great advantage for BIOSID.

Role in the project

Its role in BIOSID will mainly focus on the following tasks:


The Nuffield Department of Surgical Sciences (University of Oxford)

Presentation

logo_oxfordThe Nuffield Department of Surgical Sciences (NDS) 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.

Role in the project

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 (isolated in GMP conditions) for clinical trials and perform a part of these tests, at Oxford.


Defymed

Presentation

logo_defymedSpin-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. Defymed’s strength is based on its network of national and international partners, including historical partners such as the CTTM (Centre de Transfert de Technologie du Mans) and STATICE. Defymed has a unique technology which enables it to shape these medical devices to respond to other therapeutic applications.

Role in the project

As owner of the bioartificial pancreas MAILPAN®, on which the BIOSID project is based, Defymed is responsible for managing 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

Presentation

logo_endocellsEndocells, 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. The first focus of Endocells concerns insulin-secreting cells in order to treat type 1 diabetes. These cells show a normal insulin secretion as measured by regulation of glucose level. Thanks to their unlimited availability, they are considered as good candidates for diabetes cell therapy. They will also have application as screening tools for drug discovery and biosafety testing of anti-diabetic therapeutics. 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.

Role in the project

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 longevity and survival 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.

Currently Endocells participates in two other major European programs.


The laboratory of experimental surgery of the UCL

Presentation

logo_uclThe laboratory of experimental surgery of the UCL (Université Catholique de Louvain) 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.

Role in the project

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®.