New biomaterial could encapsulate and protect implanted insulin-producing cells

Transplanting insulin-producing pancreatic cells into people with type 1 diabetes has emerged as a ground-breaking treatment for millions of patients over the past few decades. However, one of the barriers to its effectiveness is the body’s natural auto-immune response, which results in the death of the implanted cells.

In response, the EU-funded ELASTISLET project developed a semi-permeable and biocompatible material to encapsulate and protect the implanted cells from immune attack while it is being integrated into the patient’s body.

While impermeable to immune cells, antibodies and other unwanted visitors, the bio-coating allows oxygen, nutrients and glucose into the protective capsule, and insulin to enter the bloodstream.

This project represents the preclinical phase of developing this bioengineered solution and we have been working on the bioproduction, chemical modification and characterization of the smart materials at the core of our encapsulation strategy. The project is in the process of finalizing these preclinical studies. Building on the success of this phase, we will soon be ready to start first-in-man clinical studies in type 1 diabetes patients."

José Carlos Rodríguez-Cabello, Project Coordinator, University of Valladolid, Spain

Using stem cells

The project hopes to solve another barrier to cell-transplantation treatment, which is the need for large amounts of pancreatic cells from deceased donors. It has been using human stem cells that are driven to become insulin-producing cells.

Researchers studied both encapsulated pancreatic islets and encapsulated human induced pluripotent stem cells to determine their behavior and functionality after implantation in preclinical models. These preclinical studies are also being finalized.

The project’s multidisciplinary approach draws on synthetic biology, nanobiotechnology and molecular and cellular biology.

The smart, bioengineered materials to be used in the ELASTISLET capsules are named elastin-like recombinamers and have not been tried before to treat diabetes. They are inspired by a natural protein, elastin, that is found in the body’s connective tissue. It can be manipulated to have multifaceted chemical, physical and biological properties.

These advantages allow the capsules to mimic the natural tissue environment to ensure they do not provoke an immune response. The capsules are designed to allow the recipient’s blood vessels to grow on to them – but not into them, which would trigger an immune response.

Other applications

‘The smart biomaterials at the core of our therapeutic solutions have been emerging with extraordinary strength, not only in the field of cell therapy, but also in many different areas of biomedicine, such as regenerative medicine, tissue engineering and drug delivery,’ says Rodríguez-Cabello. ‘Our efforts thus contribute to provide further evidence of their versatility and extraordinary potential to impact on other diseases and conditions.’

Type 1 diabetes leads to increased risk of developing an array of life-threatening problems, in the long term. Incorrect levels of glucose can result in damage to a variety of tissues and organs, in particular blood vessels, the heart and kidneys, the eyes and nerves.

According to the project, the number of people with diabetes in Europe is expected to reach 38 million by 2030, increasing the financial burden on the health care system. Recent studies found that the overall cost of diabetes is estimated to exceed EUR 188 billion in the UK, Spain, Italy, France and Germany. A cost-effective solution such as the one the project is offering could help significantly reduce this.

The project developed a maze game – Discover the Isle of Elastislet – as a part of a range of communication materials to spread the message about the disease and encourage learning while playing. The game is an educational project designed to reach teachers, pupils, parents and children with diabetes as well as the general public. Players answer simple questions about diabetes, while trying not to get lost, as they discover how the research is addressing cell transplantation treatments for the disease.