Published on 17 December 2015

A new centre is being set up by the NHS in Liverpool to produce stem cells for a ground-breaking treatment aiming to combat diabetes-related kidney disease.

Diabetes is the most common cause of end stage kidney disease, and is estimated as the cause of death for around 40,000 people each year. Diabetes-related kidney disease is one of the most serious health problems facing the NHS with an annual bill of £1 billion towards treatment. There are 2.7 million people diagnosed with diabetes in England, a number that is increasing by about 5% per year. Type 1 diabetes makes up around 10% of these cases, with the rest being type 2 diabetes.

NHS Blood and Transplant will produce a special type of stem cell, known as stromal stem cells, for people with diabetes in England and Northern Ireland who are taking part in an international clinical trial. NHS Blood and Transplant will use a bioreactor at its Liverpool site to expand samples of around 20 million stromal cells up to around 800 million cells, ready for use in patients.

The UK-based people taking part in the trial will be treated at University Hospitals Birmingham NHS Foundation Trust and Belfast Health and Social Care Trust. The first training runs for stem cell production in Liverpool began in October 2015. The first treatments are due in early 2016.

Stem cells will be produced to combat diabetes-related kidney disease

Stromal stem cells can separate into a variety of different cell types - for example bone cells, cartilage cells, and fat cells. However, they also have the ability to help control the body’s immune responses.

As part of the trials specific doses of stromal cells will be injected into the bloodstream of people with diabetes to try and slow down or stop the progression of diabetic kidney disease by better regulating the body's response. People with diabetes have high levels of blood sugar, which can lead to a series of reactions that cause the body to reduce blood supply to the kidney, killing off kidney tissue.

Dr Eric Austin, head of Stem Cell Immunotherapy at the Advanced Therapy Unit within the Stem Cells and Immunotherapies department at NHS Blood and Transplant’s site in Speke, Liverpool, said: “This is an exciting project for us to be involved with - especially as the treatment has the potential to lead to life saving outcomes for a major illness. We will be using NHS Blood and Transplants expertise in cellular and molecular therapy - and our extensive scientific and transport network - to play a key role in this international trial.”

The research project, called NEPHSTROM, is led by the National University of Ireland, Galway and Orbsen Therapeutics and has been funded with €6 million (£4.4 million) from the European Union Horizon 2020 programme.

Professor Timothy O’Brien, the project leader, and director of the Regenerative Medicine Institute (REMEDI) at the National University of Ireland Galway, said: “If predictions prove correct, then our healthcare systems are facing a huge task in managing the complications caused by ever-increasing numbers of people with diabetes.

“Chief among such complications will be kidney disease, which has a huge financial cost in terms of current treatments, and takes a massive personal toll on patients. Diabetes is currently the most common cause of end stage kidney disease resulting in the need for dialysis or transplantation. We are confident that by harnessing the most modern approaches in stromal cell therapeutics there may well be a way to halt the progression of diabetic kidney disease using this therapy.”

The results will be measured in terms of improvements in kidney performance as measured by urine and blood samples. If successful, the researchers will see the disease significantly slowed or halted altogether.

Professor Giuseppe Remuzzi, from the Istituto Di Ricerche Farmacologiche Mario Negri in Italy will lead the clinical trial across the four centres. He said: “The clinical experience with stromal cells is still in its infancy, mainly focused on developing novel therapeutic solutions for patients with bone marrow or organ transplantation as well as for those with a small number of autoimmune diseases. NEPHSTROM is a small but intensively studied clinical trial which will allow determination of the effective dose, and how they might function to protect the diabetic kidney.”

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