BIOCAPAN Project develops cell therapy product to treat diabetes

The BIOCAPAN Project has been funded for four years by the European Commission. It was started to develop an innovative GMP-grade cell-therapy product to treat diabetes without insulin injections, says Florence Rivera

In 2011, the World Health Organisation estimated that 356 million people suffered from diabetes, and the number is expected to reach 438 million before 2030. In 2014, 9% of the adult population (18 or older) were diabetics.

The key therapeutic issue in diabetes mellitus types 1 and 2 is glycaemic control. For these patients, the disease is ever-present in day-to-day life requiring glycaemic measurements, calculations of carbohydrate intake, and insulin injections. Reducing continuous self-monitoring and insulin injections would tremendously improve the quality of diabetics’ lives. Indeed, incorrect levels of insulin often lead to serious co-morbidities such as hypoglycaemia, stroke, heart disease, or diabetic foot (amputation). The World Health Organisation estimated that diabetes directly caused 1.5 million deaths in 2012.

The best option for such therapy is the transplantation of allogeneic islet cells, but the current state of the art limits the applicability of this approach. Implanting unmodified islet grafts requires lifelong administration of immunosuppressants, which is frequently associated with adverse effects such as higher blood pressure, higher susceptibility to infections, and higher risks of cancer. One alternative to such immunosuppressant treatments is allogeneic islet cells encapsulation to make the donor cells furtive with regard to the host immune system

In response to these facts, the BIOCAPAN Project, which stands for BIOactive implantable Capsule for PANcreatic islet immunosuppression-free therapy, has been funded for four years by the European Commission under the Horizon 2020 program (Grant number: 646272). The project has started to develop an innovative GMP-grade cell-therapy product to treat diabetes without insulin injections.

More precisely, this €8 million project is based on the implantation of smartly microencapsulated allogeneic islet cells, which will allow an effective long-lasting blood glucose normalisation and stabilisation, without the need for immunosuppressants. This treatment would be appropriate for all type 1 and about one-in-six type 2 diabetes mellitus patients – about 80 million people worldwide.

To reach this goal, the BIOCAPAN Project has three objectives:

1. Designing a complex GMP-grade bioactive microcapsule that will enhance biocompatibility, functionality and survival of transplanted allogeneic islets, in order to provide a two-year injection-free supply of insulin, without the need for immunosuppressants.
2. Establishing a method to encapsulate freshly harvested islets quickly, using a GMP-grade platform, to provide standardized and reproducible bioactive microcapsules.
3. Establishing a full preclinical validation, a complete Investigational Medicinal Product Dossier (IMPD) in accordance with the provisions of the Advanced Therapy Medicinal Products (ATMP) Regulation, and a whole clinical protocol for the submission of the Clinical Trial Authorisation (CTA) dossier to the relevant regulatory agency in order to start clinical trials within one year of completing the project.

To complete this research successfully, the BIOCAPAN Project, coordinated by CEA-Leti (FR) brings together a multi-disciplinary international team of experts comprised of Charité - Universitätsmedizin Berlin (DE), Etablissement Français du Sang (FR), European Research Services GmbH (DE), NanoImmunotech (ES), NovaMatrix (NO), Université Catholique de Louvain (BE), Université Joseph Fourier (FR), Wake Forest University Health Sciences (US).