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May 2017 NUI Galway Based NEPHSTROM Project Announces European Clinical Trial Approval
European Regulators Approve First in Man Clinical Trial of Novel Cell Therapy for Diabetic Kidney Disease
NEPHSTROM, a large European Union Horizon 2020-funded research project coordinated by NUI Galway has successfully completed a major step in the European clinical trial approval process.
NEPHSTROM, which includes 11 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 (DKD) 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. To address the critical unmet need for a therapy for DKD, NEPHSTROM brings together key leaders in the clinical treatment of chronic kidney disease, leading researchers of the mechanisms of diabetic nephropathy, and experts in stromal cell therapy development in a multi-disciplinary team.
The NEPHSTROM team is carrying out a first in man Phase 2a clinical trial of a novel stromal cell therapy (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 has demonstrated significant improvements in kidney function in pre-clinical models of DKD. 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, 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 DKD are improved, meaning that the therapy actually works, as well as being safe.
An important milestone in this clinical trial is the successful completion of a voluntary harmonisation procedure (VHP). The VHP is designed to simplify clinical trials across multiple European member states by providing a centralised application procedure for clinical trial approval.
Since the NEPHSTROM project commenced, the team have been compiling the data and preparing the documentation required for a voluntary harmonisation procedure submission. Following a submission to AIFA, the Italian Medicines Agency, the NEPHSTROM trial successfully secured VHP approval on 4 April 2017.
Commenting on the approval, Professor Timothy O’Brien, Dean of the College of Medicine, Nursing and Health Sciences at NUI Galway, and the coordinator of NEPHSTROM, said: “This approval is a vital step towards the successful completion of the NEPHSTROM trial. Achieving this has involved a tremendous amount of work on the part of the whole NEPHSTROM team.”
Patient enrolment for the NEPHSTROM trial is expected to commence in the summer of 2017.
For further information about NEPHSTROM (EC Project code 634086) visit: www.nephstrom.eu