Objectives

The BIOCAPAN project has started to develop an innovative GMP-grade cell-therapy product, to treat diabetes without insulin injections and immunosuppressant administration.

More precisely, this project is based on the implantation of smartly microencapsulated allogeneic islet cells, which will allow an effective long-lasting blood glucose level normalisation and stabilisation without the need for immunosuppressants. This treatment would be appropriate for all type I and about one in six type II 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 reach 2-years of insulin, injection-free treatment, 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 Authorization (CTA) dossier to the relevant regulatory agency in order to start clinical trials within one year of completing the project.