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  • Periodic Reporting for period 1 - ELASTISLET (Tailored Elastin-like Recombinamers as Advanced Systems for Cell Therapies in Diabetes Mellitus: a Synthetic Biology Approach towards a Bioeffective and Immunoisolated Biosimilar Islet/Cell Niche)

ELASTISLET Report Summary

Project ID: 646075
Funded under: H2020-EU.

Periodic Reporting for period 1 - ELASTISLET (Tailored Elastin-like Recombinamers as Advanced Systems for Cell Therapies in Diabetes Mellitus: a Synthetic Biology Approach towards a Bioeffective and Immunoisolated Biosimilar Islet/Cell Niche)

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

Summary of the context and overall objectives of the project

ELASTISLET is within the context of diabetes, a global epidemic that comprises a series of clinically and genetically heterogeneous physiological disorders. According to the first WHO Global report on diabetes demonstrates that the number of adults living with diabetes has almost quadrupled since 1980 to 422 million adults. This dramatic rise is largely due to the rise in type 2. However, in the two most prevalent types of DM, the most severe form of diabetes is the “type 1” variant.

Most current therapies for DM have developed in the absence of defined molecular targets or an understanding of disease pathogenesis and in the most severe cases insulin is indeed all that is needed to produce a cure, although to date, has not been able to imitate its regulated secretion. Because of its chronic nature, the severity of DM complications and the means required to control them, DM is extremely costly, both for the affected individuals and for health authorities. Moreover, we have to considerate the aggravating factor of its alarming increasing rate. This highlights the substantial financial burden that nowadays DM imposes on society as well as the expected impact that it will have in the society well-being.

Outcomes in clinical islet transplantation have progressed significantly since its inception but are mainly limited by the adverse effects of immunosuppressive therapy over the lifetime of the recipient, overall decay of graft function in all patients within 1-5 years and the limited supply of donor tissue. For this reason, ELASTISLET strategy aim at making cell therapy a real and effective treatment for DM by thoroughly addressing some critical points that seriously affects patients´ quality of life and that has not been overcome so far. The general objective of ELASTISLET is the development of a novel and breakthrough immunoisolation and scaffolding systems based on multibiofunctional elastin-like recombinamers (ELRs) for long-term and efficient pancreatic islet and human induced pluripotential stem cells (hiPSCs) transplantation for Diabetes Mellitus (DM) treatment. This objective is materialized in the fabrication of multibiofunctional capsules that are able to efficienciently inmmunoisolate their content but, on the other hand, are able to promote the complete biointegration and fusion of the capsule and its content in the host surrounding tissues (Figures 1 and 2).

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

At the time of publication of this report, 13 ELR variants have been achieved as scaffolding systems based on the newest techniques on gene engineering, biotechnology, chemical modification and material processing. These multi-bioactive and tailor-made ELRs were produced, purified, fully characterized and made available to ELASTISLET partners.

During this time, the extension of a novel reactive mechanism to coat islets/cells has been also verified with the ELRs. The buildup of the ELR capsules was tested with different settings in order to stablish the most appropriate conditions. Preliminary assays to verify the effectiveness of the coating have shown promissing results.

The ELRs produced as encapsulating materials has been tested in order to know different features very important for the future application:
• Immunologic response against ELRs
• In vivo ability to control angiogenesis.

In parallel with this work, attempts to obtain, characterize and deliver hiPSCs single cells and spheroids have given their first satisfactory results and various batches of spheroids were generated and delivered to partners.

On the other hand, a number of communication tools and materials have been developed to promote the project and its activities. Data management activities have been continuously be performed in order to update project’s database according to scientific traceability and regulatory needs with the implementation of common procedures for the management of generated data and to facilitate and standardize the rules for exploitation, protection and dissemination of results. A considerable effort has also been made to reach the widest audience and raise their awareness about Elastislet as possible.

Reports with a classification analysis of the potential final product in its different variants according to the current regulatory guidelines and discussion of actual products classified by the European medicines Agency (EMA) have been released. Preparation of the briefing documentation to request and hold a meeting with the innovation task force (ITF) at the EMA has been conducted in the last months of the project.

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)

Encapsulation technology applied to cell and tissue therapies for the treatment of the DM has achieved moderate success for the time being. This is mainly due to the simplistic approaches in the selection of the encapsulating materials and technologies that, addressing permselectivity and immuno-isolation of the transplanted tissues as the only factors affecting the implant survival and function. The materials proposed for ELASTISLET project, obtained by recombinant DNA technology, aim to develop an advanced, complex and innovative cell encapsulation concept that goes a step forward that those proposed so far.
The expected potential impacts of ELASTISLET are:
• Improvement of the quality of life of both type I and type II patients with DM:
Since the start of the project, this landscape seems to have remained unvaried. The current most innovative strategies are still either in the preclinical or in the clinical phase of their development: currently there is no therapy on the market that fully guarantees insulin independence nor the total elimination of immunosuppressive drugs for transplant patients.
Moreover, islet transplantation has not been offered to type 2 diabetics so far and ELASTISLET aims at addressing the needs of these patients as well.
• Reduced direct and indirect costs linked to the disease and its treatment, and wide availability of treatments:
The direct costs of diabetes are mainly due to medical expenditures. However, the main problem is mostly attributable to the disease chronification.
By developing advanced biomaterials and improved methods for islets/hiPSC cells encapsulation that can overcome the need for aggressive immune suppression, ELASTISLET may significantly reduce those post-transplantation medical expenditures.
• Implementation of relevant objectives of the European Innovation Partnership on Active and Healthy Ageing.
• Improving innovation capacity and the integration of the new knowledge:
Considering that ELASTISLET project aims at developing a fully innovative and exploitable encapsulating concept, it is expected that they will have an important impact in the European biomaterials industry and that they will emerge with extraordinary strength in many different areas of biomedicine such as regenerative medicine, tissue engineering and cell therapy.
• Environmental and socially important impacts:
An available and effective healing treatment, based on cell therapy, such as the one proposed by ELASTISLET, would significantly alleviate the social and economic strain of this disease.
Moreover, all the steps involved in the whole approach, are based on fully clean and sustainable technologies, which do not use any contaminant reactive nor produce any dangerous wastes and have minimum electrical consumption.

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