MAILPAN® (MAcroencapsulation of PANcreatic Islets) is a prototype of bioartificial pancreas usable in the human designed to treat type 1 diabetic patients. The prototype was developed along different stages since 1996 and led to the creation of the SME called Defymed in 2011. Next step is now to bring the prototype to the pre-clinical and clinical phases necessary to the ensuing commercialization of MAILPAN® whose ultimate goal is to improve the life of at least 20 million persons in the world while providing positive effects on healthcare management and expenses, the environment and the competitiveness of the biomaterials industry in Europe.
To respond these challenges, BIOSID project, of 36-month duration, including 5 technical WorkPackages (WPs 1 to 5), one dissemination WorkPackage (WP6) and one managerial WorkPackage (WP7), has been launched since January 2013. This project intends to bring the most modern and up to date improvements that the MAILPAN® bioartificial pancreas still needs and can receive such as:
- to understand the needs of insulin-secreting cells in the bioartificial pancreas,
- to meet these needs, by formulating a novel cell culture medium, in order to improve their life expectancy in the bioartificial pancreas,
- validate the MAILPAN®, associated with insulin-secreting cells of different types/origins, in diabetic large animals and then in humans.
The ultimate goal of this project is to provide a solution to the main obstacles of human pancreatic transplants (islets of Langerhans or entire pancreas), which are immune rejection and the lack of matching donors.
To ensure all the chances of success of this project, the Centre Européen d’étude du Diabète (CeeD) and its spin-off Defymed, two French SMEs based in Strasbourg (France), have built a strong consortium uniting 5 other partners from complementary fields of expertise. In this case:
- AvantiCell (ACS), a Scottish SME- UK,
- the Department of Endocrinology, Diabetes and Nutrition from the University Hospital Center of Montpellier (CHU)- France,
- the Nuffield department of Surgical Sciences from the Oxford University (NDS)- UK,
- Endocells, a French SME based in Paris- France,
- and the laboratory of Experimental Surgery of the Catholic University of Louvain (UCL)- Belgium.
The full consortium brings together 4 SMEs and 3 public research organizations, from three different countries (France, Belgium and United Kingdom), which will each have a role in the validation of the various stages of the project. The consortium’s expertise includes encapsulation techniques, cellular, transplantation and formulation engineering as well as a clinical expertise.
BIOSID is a Collaborative Project supported at the level of 5 469 603 € through Cooperation Program of the European Community’s FP7, Grant agreement number HEALTH-F2-2012-305746. BIOSID addresses the topic HEALTH-2012-2.4.3-1: “Innovative approach to manage diabetes”.
Principle of the Bioartificial Pancreas
The development of a bioartificial pancreas is based on an effective immune-isolation of insulin-secreting cells based primarily on their encapsulation using artificial membranes impermeable to molecules involved in the rejection but permeable to glucose, insulin, oxygen and nutrients.
Therefore, no immunosuppressive therapy is anymore required. This physiological solution allows the cellular therapy to become a widely deployed reality
Three functions are a pre-requisite for the bioartificial pancreas:
• Protect the transplanted cells from the recipient’s immune system
• Protect the recipient from the transplanted cells
• Maximize the function of the transplanted cells
Impact of BIOSID
The BIOSID project aims to improve the lives of patients with type 1 diabetes by providing a complete physiological treatment. In comparison with current treatments for type 1 diabetes, the bioartificial pancreas intends to bring several benefits and impacts significantly improving the quality of life for many patients with diabetes, allowing thus:
- The control of diabetes in a physiological way, without requiring an external supply of insulin and without the continuous monitoring of blood sugar,
- The transplantation of pancreatic islets without immunosuppressive treatment. Thus, this therapy could be extended to a larger number of patients,
- A simple routine visit to a diabetology unit every 3 to 6 months is required to replace the transplanted cells, in the case those are exhausted. Thus, the old cells are replaced by new ones by a simple drainage/ filling action through entry/ exit ports,
- The reduction of long-term complications of diabetes through a normalization of blood sugar,
- The disappearance of multiple daily insulin injections done by the patient, as well as the obligation of taking their meals at fixed times,
Access to other sources of cells, of animal or genetically modified origin, available in infinite amounts. Thus, this solution will allow to treat a larger number of diabetic patients and alleviate the organ shortage.