BIOCAPAN addresses the three main obstacles for a successful immunosuppressant-free cell therapy of insulin deficiency in a comprehensive approach:
- safe and reliable harvesting of cells, EFS partner has vast experience in safe and reliable GMP-grade cell-harvesting and has achieved validation through the transplantation of islets in clinical trials (GRAGIL, TRIMECO) using their NSMA approved process.
- long term survival and sustained efficacy of the implanted cells and UCL, CUB, WFUHS, UGA, NOVA, NIT and CEA join their expertise to develop an innovative bioactive microcapsules that will prevent fibrosis, enhance cell survival through both cell microenvironment generation and cell oxygenation and finally, modulate the immune system.
- reproducible manufacturing: Today’s standard processes (dripping) in microencapsulation are highly operator-dependant. Relying on CEA expertise, BIOCAPAN will develop and validate a microfluidic platform to sort and encapsulate the harvested cells in a complex, bioactive microenvironment. Our process will allow control of all system parameters. The completely automated procedure will ensure a high reproducibility of the microcapsule’s characteristics and will be easy to scale-up and to transfer to clinical trials (no variance due to human intervention in the production), or to other laboratories for cell therapy.
If successful, BIOCAPAN would lead to a free immunossupressant cell therapy for diabetic patients avoiding daily glucose controls and daily multi insulin injection At the same time the natural glycemic homeostasis, supported by the implanted islets, would reduce the prevalence of comorbidities offering an endogenous glycemic control. A successful biotherapy with microencapsulated islets will fulfill the expectations of millions diabetic patients in terms of quality of life and more efficient control of glycemic control without exogenous insulin delivery.
About 80 million diabetes patients worldwide could profit one day from the BIOCAPAN project.