Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn

RCSI and AMBER Led EU Consortium Receives €8.9 Million Funding to Develop Materials and Cell Based Treatments for Diabetes

19 May 2015

Programme of research will be a game-changer for people with type 1 diabetes and insulin-dependent type 2 diabetes

Major new EU funding for research into diabetes was announced today by a group led by RCSI (Royal College of Surgeons in Ireland) and AMBER (Advanced Materials for Bioengineering Research). The DRIVE (Diabetes Reversing Implants with enhanced Viability and long-term Efficacy) consortium involves fourteen partners from seven European countries and has received €8.9 million funding as part of the Horizon 2020 - Research and Innovation Framework Programme.

The DRIVE programme will create thirteen new jobs in Ireland and it will develop natural materials and new surgical devices to enhance the transplant and survival of insulin producing pancreatic islets for the treatment of diabetes. The DRIVE programme is co-ordinated by Dr Garry Duffy, Department of Anatomy and Tissue Engineering Research Group, RCSI and AMBER Investigator. In addition to the fourteen partners, the DRIVE consortium brings together internationally recognised academics, large medical devices industries and clinical experts in islet transplantation including Oxford University. Irish partners include Dublin City University, University College Dublin and Boston Scientific.

Pictured (l-r) are Dr Helena Kelly, (Deputy Co-ordinator of DRIVE), Senior Lecturer in Pharmaceutics at RCSI and Dr Garry Duffy (Co-ordinator for DRIVE), Department of Anatomy and Tissue Engineering Research Group at RCSI and AMBER Investigator

Diabetes mellitus is a chronic disease characterised by high blood sugar (glucose). If not treated carefully, diabetes causes several debilitating side effects including heart disease, damage to the eyes, kidneys and nerve endings (e.g. hands, feet) and can lead to premature death. The total number of people living with diabetes in Ireland is estimated to be over 225,000. According to the international diabetes federation (IDF), 382 million people worldwide have diabetes and in 2013 an estimated 5.1 million deaths were attributable to the disease, representing 8.4% of global adult mortality. Blood glucose is high in diabetes because of the inability of the pancreas to produce sufficient insulin, a hormone that controls blood sugar. Currently the main treatment for diabetes is the daily injection of insulin. In patients where control is poor, transplantation of pancreatic cells (which contain insulin-producing β-cells) is possible. However there are challenges with this therapy including the short supply of donor pancreases, the need to use 3-4 pancreases to get enough β-cells for treatment and poor graft survival and retention at the transplant site.

The DRIVE consortium will address these challenges by developing a completely new system to deliver pancreatic β-cells effectively in a targeted and protected fashion. This will mean that fewer donor pancreases are needed for cell transplantation allowing more patients to avail of a more effective longer-lasting treatment with less demand on donor pancreases. Additionally, the consortium will investigate the combination of DRIVE's technology with future stem cell-derived β-cells that will widen the availability of islet transplantation therapy to all insulin-dependent patients.

Dr Garry Duffy, Department of Anatomy and Tissue Engineering Research Group, RCSI and AMBER Investigator, commented on the research funding: "We are delighted to lead the DRIVE programme and to translate new collaborative research for the benefit of patients with diabetes mellitus. Regenerative medicine and stem cell therapies have the potential to revolutionise the treatment of patients who have diabetes, and through DRIVE we will develop new technologies to enhance stem cell therapies for these patients by increasing targeting and ease of delivery using advanced biomaterials."

Welcoming the announcement, Professor Ray Stallings, Director of Research at RCSI said: "RCSI's leadership of the DRIVE consortium builds on the College's expertise in regenerative medicine and industrial collaboration. This new programme will help accelerate the development of new treatments for the benefit of patients, in keeping with our strategy of bench to bedside translational research."

RCSI researchers involved in the consortium include Dr Helena Kelly (Deputy Co-ordinator) and Dr Eduardo Ruiz-Hernandez, both from RCSI School of Pharmacy; and Professor Seamus Sreenan and Dr Diarmuid Smith Consultants in Diabetes and Endocrinology. The project, which has received €8.9 million direct EU contribution, is funded by the European Horizon 2020 Research and Innovation Framework Programme from June 2015 to May 2019. Dr Duffy's proposal was the highest ranked application across all the Leadership in Enabling and Industrial Technologies (LEIT) proposals throughout Europe, ranked 1st out of 18 funded from 62 projects submitted at Stage 2, and 326 submitted at Stage 1.

Pictured (l-r) are Dr Eduardo Ruiz-Hernandez, Senior Research Fellow, RCSI School of Pharmacy; Dr Garry Duffy (Co-ordinator for DRIVE), Department of Anatomy and Tissue Engineering Research Group at RCSI and AMBER Investigator; Dr Helena Kelly, (Deputy Co-ordinator for DRIVE), Senior Lecturer in Pharmaceutics at RCSI; and Dr Liam Burke, Project Manager, RCSI School of Pharmacy

DRIVE's β-System consists of a β-Gel, which contains the pancreatic β-cells within a pancreas mimicking gel; which itself is protected within a capsule called a β-shell. This is delivered using a specialised injection catheter, called β-cath, which offers a more minimally invasive surgical procedure than is currently used. Boston Scientific Ireland Ltd. are working with RCSI on the new surgical procedure.

The current transplantation technique offers patients natural glucose control for 1-2 years. DRIVE's β-system aims to provide control for up to 5 years by increasing the longevity of the β-cell transplant. The system offers further advantages through the slow release of immunosuppressant drugs by the β-shell, reducing the patient's need for long-term anti-rejection medication, which has harmful side effects. The β-shell will also be retrievable, so it can be removed and replenished after the 5-year period. DRIVE's 5-year work plan will include laboratory testing, with a view to human testing at the end of the project.

Professor Paul Johnson, Director of the Oxford Islet Transplant Programme and Professor of Paediatric Surgery at the University of Oxford, said: "Over the past 10 years, the transplantation of particular pancreatic cells known as islet cells (which can sense blood sugar levels and release insulin to maintain normal levels) has achieved promising results in adults who have developed the severest complications from insulin-dependent diabetes. The challenge is to now make sure that more people can benefit from this minimally-invasive treatment. Ultimately we would hope that it can be used to reverse diabetes in children soon after diagnosis. The DRIVE Consortium brings together some of the leading researchers in Europe in the fields of bioengineering, cell biology, and cell transplantation. The overall aim is to develop novel membranes to protect the transplanted islets from rejection ensure that islet transplantation can be undertaken without the need for the patient to take anti-rejection medication, with all the associated complications. This programme of research could be a real game-changer for people with Type 1 diabetes and the team in Oxford are very excited to be part of this state of the art research collaboration."

The DRIVE Consortium represents a major interdisciplinary effort between stem cell biologists, experts in advanced drug delivery, research scientists, clinicians and research-active companies working together to develop novel therapeutics to address the challenges of treating diabetes. The researchers will optimise adult stem cell therapy using smart biomaterials and advanced drug delivery, and couple these therapeutics with minimally-invasive surgical devices.

RCSI is among the top 50 most international universities in the world (Times Higher Education University World Rankings, 2014-15). It is a not-for-profit health sciences institution focused on education and research to drive positive change in all areas of human health worldwide. RCSI is headquartered in Dublin and is a recognised College of the National University of Ireland. In 2010, RCSI was granted independent degree awarding status by the State, which enables the College to award degrees alongside its traditional powers to award licentiates.