The stromal cell therapy, ORBCEL-M™, developed as part of NEPHSTROM, a European Union Horizon 2020-funded research project, has been approved to begin testing in a randomised, double-blind, and placebo-controlled European clinical trial to treat diabetic kidney disease.
Orbsen’s ORBCEL-M™, a novel highly purified positively-selected stromal cell therapy for diabetic kidney disease, has demonstrated significant improvements in kidney function in pre-clinical models of diabetic kidney disease, which represents a significant step towards preparing this therapy for clinical application.
The pan-European clinical trial is being led by nephrologist, Professor Giuseppe Remuzzi at the Mario Negri Institute in Bergamo, Italy with clinical trial recruitment sites in Italy, Ireland (HRB Clinical Research Facility, Galway), and the UK (University Hospitals Birmingham NHS Foundation Trust, Birmingham and Belfast Health and Social Care Trust, Belfast). The primary aim of the clinical trial is to establish the safety and efficacy of ORBCEL-M™ and to show that important markers of diabetic kidney disease are improved, thereby indicating the safety and efficiency of ORBCEL-M™.
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. The five-year mortality rate is 39% – a rate comparable to many cancers.
Professor Timothy O’Brien, Dean of the College of Medicine, Nursing and Health Sciences at National University of Ireland Galway, and NEPHSTROM coordinator, comments: “This approval is a vital step towards the initiation of clinical development of this promising new approach to the treatment of diabetic kidney disease, and patient enrollment will commence this summer.”
The trial successfully secured voluntary harmonisation procedure (VHP) approval in April 2017. The VHP is designed to simplify clinical trials across multiple European member states by providing a centralised application procedure for clinical trial approval.