Human Clinical trials are scheduled to begin by 2016 for the first European implantable bioartificial pancreas that has been developed by a French start-up for treating patients with type 1 diabetes. Type 1 diabetes, known as insulin-dependent diabetes, affects 25 million people worldwide. Current therapies have certain limitations. Daily insulin injections using pens or pumps are inconvenient for patients and do not enable their glycaemia to be regulated correctly. Pancreas and islets of Langerhans transplants are limited by the tiny number of donors (one pancreas donor per three hundred patients) and the necessary life-long immunosuppressive drug treatment may have major side effects. “Hence the idea of a pouch made of watertight material, full of insulin-producing cells needed by the body and safe from attack by its immune system,” explains Séverine Sigrist, Defymed's CEO. This Strasbourg-based medtech company designed this bioartificial pancreas following research carried out by the Centre Européen d’Etude du Diabète (CEED), of which it is a spin-off.The MAILPAN (MAcroencapsulation of PANcreatic Islets) innovation is the result of two European projects. The concept of immunoprotecting islets via encapsulation in semi-permeable artificial membranes was first validated during initial work carried out as part of the 4th European Framework Programme for research and development. A second project forming part of the 6th Framework Programme established the system’s materials and expected functionalities in pigs. At the end of these programmes, three patent families were registered for the device's membranes, materials, shape and surface treatment. Defymed's bioartificial pancreas which is implanted in the abdominal cavity is now available as a circular pouch of less then 13 cm in diameter and less than 2 cm thick. The innovation of these encapsulation chambers for insulin-secreting cells lies in their thermoplastic polymer semi-permeable membranes. “Their porosity and pore density results in selective diffusion, allowing through molecules up to 150 kilodaltons,” says Richard Bouaoun, Defymed's director of operations. Oxygen, nutrients, glucose and insulin pass freely through the membrane, which is impermeable to immune cells and antibodies. For this reason, no immunosuppressive drug treatment is required. Furthermore, the membrane surface undergoes specific treatment before being implanted. This maximizes the system's biocompatibility and speeds up vascularization around it. Catheters plugged in via input and output connectors fill the pouch with insulin-secreting cells. These can be obtained from various sources: islets isolated from human and porcine donors, or human-derived genetically modified cells.Defymed's Strasbourg-based researchers are currently carrying out nanometric mechanical resistance and watertightness tests on every component of bioartificial anchors. These tests in mini pigs are being performed within the framework of a French consortium, with five Lorraine-based companies and laboratories joining forces on the collaborative MECABARP project. A second European consortium, bringing together seven French, Belgian and English academic, hospital and industrial partners, has obtained 5.5 million euros of European Commission funding to carry out the first clinical trials at Montpellier Regional Hospital in France and the University of Oxford in the UK; these are due to start in early 2016. Sixteen patients – twelve in Montpellier and four in Oxford – will be enrolled. “We’re still looking for another 2 million euros to prepare the next clinical phase,” confess Sigrist and Bouaoun. Pharmaceutical laboratories producing stem cells are starting to take an interest in Defymed’s innovative medical device, which could address other organs affected by insufficiency, such as the liver and the kidneys.