This is the first such trial in the UK that involves the transplantation of pancreatic islets derived from stem-cells into patients with type 1 diabetes.
Participants in the Vertex study will have experienced episodes of severe hypoglycaemia requiring third party intervention. This is when blood sugar levels become dangerously low without the patient being aware of their worsening condition and this can lead to coma and even death.
DRWF made an unprecedented £1.2 million award to NDS in 2004 for the provision of a Human Islet Isolation Facility.
This centre of excellence opened at the Churchill Hospital, Oxford in 2006 and was pivotal in the decision-making process in 2008 which led to the NHS funding the clinical islet transplant programme for a small cohort of people living with type 1 diabetes and hypoglycaemia unawareness.
Since then, DRWF has funded around 30% of the Facility staff, committing almost £4 million in total to furthering the non-clinical research element of the Oxford Islet Transplant Programme.
Patients undergoing treatment as part of this new ground-breaking first trial with Vertex, will need to take immunosuppression (anti-rejection medication) as they would for any other transplant.
However, the Oxford team are planning to start another Vertex trial soon that uses encapsulated stem-cell-derived islets without the need for this medication.
We hope that this trial will be an important step towards our ultimate goal to be able to reverse diabetes in children soon after diagnosis - Professor Johnson
Professor Paul Johnson, Director of the Oxford Islet Transplant Programme and the Oxford DRWF Islet Isolation Facility, and UK Chief Investigator for this trial said: “Islets derived from stem cells offer the potential for an unlimited source of islets that could be a game-changer and transform the future treatment of diabetes.
“We are very excited about this ground-breaking trial with Vertex, which we are conducting in collaboration with the team in Newcastle. While islet transplantation is a life-changing treatment in patients with severe hypoglycaemia who have exhausted conventional insulin and pump treatment, it relies on the extraction of insulin-producing ‘islets’ from donor pancreases.
“The shortage of pancreas donors, and the inefficiency of the islet extraction process, currently limits the wider availability of this important treatment. We hope that this trial will be an important step towards our ultimate goal to be able to reverse diabetes in children soon after diagnosis."
DRWF Chief Executive, Sarah Tutton said: “Whilst there is much work to be done, we are very excited about the Vertex study’s potential to address these long-standing issues of a treatment which can transform the lives of people with type 1 diabetes and hypoglycaemia unawareness. If we can find a sustainable supply of insulin producing cells for transplant, and ultimately mitigate the need for life-long immunosuppression treatment, we will be able to make islet transplants more widely available to more people with diabetes.”
For any information, please contact Professor Johnson via islet.trial@nds.ox.ac.uk