NHS Blood and Transplant has begun manufacturing stem cells from a site in Liverpool for use in a ground-breaking clinical trial involving patients with diabetic kidney disease.
The trial will assess a novel cell therapy - Cyndacel-M - discovered by National University of Ireland (NUI) spin-out Orbsen Therapeutics that researchers hope will stave off the progression of kidney disease in patients with diabetes, the treatment of which places a huge drain on NHS resources.
NHS Blood and Transplant will use its bioreactor to produce stromal stem cells - which can differentiate into a variety of connective cell types and also have the ability to help regulate the body’s immune responses - to expand samples of around 20 million up to around 800 million cells, ready for use in patients.
These are to be injected into diabetics with kidney disease in England and Northern Ireland taking part in international first-in-man trials scheduled for May next year across four different sites (in Galway, Belfast, Birmingham and Bergamo).
UK patients participating in the trial will be treated University Hospitals Birmingham NHS Foundation Trust and Belfast Health and Social Care Trust, at which researchers will test the success of the therapy through urine tests and blood samples to measure kidney function.
Unmet medical need
It is estimated that by 2040 diabetic kidney disease will affect around 200 million people in the European Union. In most cases there is no effective medical treatment, and current approaches including drugs, dialysis and kidney transplants all have “significant costs and only provide limited protection against adverse outcomes”, according to Orbsen, underscoring the vast unmet medical need.
“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,” said Timothy O’Brien, Director of the Regenerative Medicine Institute at NUI Galway.
The research project, called NEPHSTROM, has received funding of 6 million euros from the European Union’s Horizon 2020 programme.