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BIOCAPAN Report Summary

Project ID: 646272
Funded under: H2020-EU.

Periodic Reporting for period 1 - BIOCAPAN (BIOactive implantable CApsule for PANcreatic islets immunosuppression free therapy)

Reporting period: 2015-06-01 to 2016-11-30

Summary of the context and overall objectives of the project

Type I diabetes mellitus (T1DM) patients need to treat themselves with insulin injections several times a day. Among Type II diabetes mellitus (T2DM) patients, one in six patients eventually needs to take insulin. For these patients (about 80 million worldwide) the disease is ever-present in day-to-day life requiring glycaemia measurements, calculations of carbohydrate intake, and insulin injections. Mal-adjusted levels of insulin often lead to serious co-morbidity factors such as hypoglycaemia, stroke, heart diseases, nephropathy, retinopathy, or diabetic foot (amputation).
The key therapeutic issue in diabetes mellitus type I and II is glycaemic control. Reductions of constant self-control, of insulin self-injections, and of long-term complications would have tremendous benefit for the patient’s quality of life. The best therapy option is the transplantation of allogeneic islet cells, but the current state of the art limits the applicability of this approach. Implanting unprotected grafts requires lifelong administration of immunosuppressants, and protecting the cells against adverse immune reactions by current encapsulation strategies reduces their functionality and survival to an extent that makes frequent ‘refresher’ implantations necessary. Currently, a maximum of 9 months insulin-independency has been shown for the encapsulated approach.
In BIOCAPAN we aim at developing an innovative treatment, based on the implantation of smartly microencapsulated allogeneic islet cells, which will allow an effective long-lasting blood glucose normalization and stabilization, without the need for immunosuppressants. We have three objectives:
1. Design 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. Establish a method to encapsulate freshly harvested islets quickly, using a GMP-grade platform, to provide standardized and reproducible bioactive microcapsules.
3. Establish 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.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The BIOCAPAN project started in June 2015 allowing 9 teams around Europe (and US) to join their forces to reach these ambitious goals.
The strategy chosen to protect pancreatic islets from immune-rejection is to microencapsulate the pancreatic islets into soft, porous and biocompatible microcapsules. During this first period of the project, based on a bibliographic study, the consortium agreed on the definition of a reference microcapsule and an a priori bioactive microcapsule. Different biomaterials have been developed or are still under development. Each new biomaterial developed is added to the reference microcapsule for in vitro and in vivo evaluation. First assessed biomaterials to reconstruct the pancreatic islets microenvironment showed in vitro benefits. Results should be confirmed in the coming month. Although first biomaterials synthesized have been successfully made to reduce the pericapsular fibrosis and to enhance pancreatic islets oxygenation, new syntheses are on-going to further improve biomaterials performances.
Additionally, to answer the second objective of BIOCAPAN, the whole chain of the process has been assessed. Going from production of biomaterials, cells isolation to the process of microencapsulation, all steps have been depicted and risks analysis is planned. Step by step, the process is being optimized to be able to integrate a cell therapy unit by the end of the project. GMP production of candidate biomaterials already started. First prototype of a microencapsulation platform has also been designed and is currently under fabrication.
In parallel, the consortium defined the clinical trials specifications and received scientific advices from the regulatory agencies in order to complete the IMPD by the end of the project. Further characterization of the final product has to be done and in vitro and in vivo preclinical test strategy is being defined.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

During part of this first period of the project, the consortium started in vitro and in vivo validation of different biomaterials. First promising results have to be confirmed on more human pancreatic islets samples to really assess the benefits of developed biomaterials.
If successful, BIOCAPAN would lead to a therapy option that eliminates the need for daily controls and interventions for at least two years. At the same time the natural glycaemic homeostasis, supported by the implanted islets, would reduce the prevalence of comorbidities. A successful biotherapy with microencapsulated islets will fulfill the expectations of the patients in terms of quality of life, the requirements of public health in terms of reduced cost in use due to better quality of glucose control, and more efficient control of insulin levels than any other insulin delivery methods.

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