NEPHSTROM, a large European Union Horizon 2020-funded research project coordinated by NUI Galway is now actively enrolling patients in a clinical trial.
NEPHSTROM, which includes 12 academic, clinical and commercial partners from Ireland, Germany, the Netherlands, Belgium, Italy and the UK, is carrying out a randomised, placebo controlled clinical trial of a novel allogeneic stromal cell therapy to treat diabetic kidney disease. Diabetic kidney disease is the single leading cause of end stage renal disease in the industrialised world, accounting for 40% of new cases of end stage renal disease in the US and EU and has a five-year mortality rate of 39% – a rate comparable to many cancers.
The NEPHSTROM team is carrying out a first in man clinical trial of a novel stromal cell therapy called ORBCEL-M, for diabetic kidney disease. ORBCEL-M was discovered by Dr Stephen Elliman, Chief Scientific Officer at Orbsen Therapeutics, an NUI Galway spinout cell therapy company. ORBCEL-M performed well in pre-clinical models as a therapy for diabetic kidney disease demonstrating significant improvements in kidney function and structure. The NEPHSTROM clinical trial represents a significant step towards preparing this therapy for clinical use.
The pan-European NEPHSTROM clinical trial is being led by the renowned nephrologist, Professor Giuseppe Remuzzi at the Mario Negri Institute in Bergamo, Italy with clinical trial recruitment sites in Italy, Ireland (HRB Clinical Research Facility, NUI Galway), and the UK (UHBFT, Birmingham and BHSCT, Belfast). The primary aim of the clinical trial is to establish the safety and efficacy of ORBCEL-M. The NEPHSTROM team of researchers also hope to show that important markers of diabetic kidney disease are improved, meaning that the therapy actually works, as well as being safe.
Professor Timothy O’Brien from NUI Galway, founding Director at Orbsen Therapeutics and coordinator of the NEPHSTROM consortium, said: “In my clinical practice, I encounter patients commonly with diabetic kidney disease who face the unpleasant possibility of dialysis or kidney transplantation. The outcome of this clinical trial may give patients another alternative and new hope.”
Steve Elliman, Chief Scientific Officer in Orbsen Therapeutics at NUI Galway, said: “Encouraged by the promising results of the pre-clinical models, we are optimistic taking ORBCEL-M to the next stage to further investigate the immunotherapy as a solution to slow or stop progressive diabetic kidney disease. On behalf of Orbsen, we are privileged to be engaged with some of the European Union’s leading researchers and institutions through NEPHSTROM.”
Professor Giuseppe Remuzzi, Mario Negri Institute, Bergamo, Italy, and the clinical trials lead investigator, commented: “It’s a privilege to have the first patients enrolled and receiving the experimental treatment at the Mario Negri Institute. The complementary skills and expertise of the four participating European centres provide a critical network demonstrating the clinical feasibility of this innovative therapy and the opportunity for additional coordinated trials in diabetic patients with progressive kidney disease for whom new therapies are urgently needed.”