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In type 1 diabetes, the body does not produce insulin, a hormone that the body needs to take glucose from the bloodstreamto the cells of the body. A lack of this hormone leads to increased blood and urine glucose. Diabetes is ultimately fatal if left untreated. This condition is usually managed through administering insulin, which is effective but can impair a patient’s quality of life. This is why the EU-funded project NEXT explored alternative treatments such as cell transplantation.
“In this project we set out to engineer immune-protected pancreatic islets from beta cells, which store and release insulin, and vascular cells, which are found in the interior surface of blood vessels and lymphatic vessels. The engineered islets can then be transplanted as an alternative to conventional type 1 diabetes treatments,” explains project coordinator Matteo Santin of the University of Brighton in the UK. “Despite the progress that has been made in this field to date, these kinds of interventions often require aggressive immunosuppression treatments in order to prevent the patient rejecting donor cells.”
Marketable scientific breakthroughs
To address these challenges, the NEXT project has pioneered the development of nanostructured biomaterial capable of mimicking the natural mechanisms of both beta cells and vascular cells.
The team has also delivered ‘nano-reservoirs’ capable of releasing immune-suppressants locally to provide a first line of defence against a recipient’s immune response. Finally, the project has developed proteins capable of locally and temporarily suppressing immune rejection.
The different technological components developed by each of the NEXT partners are already showing market potential.
“Each partner stands to benefit from their own research, as well as synergies through combining with other partners,” says Davide De Lucrezia deputy coordinator of the project. For example, one project partner has developed modular assembling for the fast fabrication of protein mutant libraries. This method, called the DNA modular assembling technique (DNAmate), is now available worldwide to scientists.
Another partner has developed a continuous microgravity reactor for cell culturing, which is set to hit the European market, while a reliable cell assay to evaluate early fibrosis and pancreatic islet viability has already been commercialised. Finally, a nanostructured polymer developed by another project partner is currently being tested in a number of cell models, and potential partners are being sought to commercialise the product.
Pre-clinical investigations underway
Taken together, these new methods will help to transplant islet cells with a reduced need for immunosuppression treatments. This will be of great benefit to patients: the World Health Organisation predicts that 30 million people will be diagnosed with type 1 diabetes worldwide by the year 2025.
In the long term, the project’s pioneering work could eventually result in animal cells being used, which could significantly mitigate the shortage of human cell donors for this type of procedure.
“The state of play now is that we have developed a method to assemble these cells in bioengineered pancreatic islets with or without the integration of immune-suppressants,” says De Lucrezia. “We are about to begin pre-clinical investigations, where the bioengineered islets will be transplanted in vivo to assess their safety and ability to sustain normoglycaemia [a normal concentration of sugar in the blood].”
Once the safety and efficacy tests are completed, partners will start the in vivo investigations necessary to offer full validation of the technique. The NEXT bioengineered pancreatic islet falls under ATMP (advanced therapy medicinal product) legislation, and will require significant effort to finally reach market. Nonetheless, the NEXT project, due for completion at the end of September 2017, has already delivered exploitable results.