An EU investigation into new treatments for diabetic kidney disease has advanced from animal testing into its first human clinical trials.
The international project called Nephstrom – with NUI Galway (NUIG), Ireland, as the co-ordinating body – has been testing a novel allogeneic stromal cell therapy to treat diabetic kidney disease for a number of years.
According to the group behind the project, kidney disease is responsible for the deaths of approximately 126,000 Europeans every year, with hypertension and cardiovascular disease also linked to it.
With no available treatments to reverse the process, the EU decided to seek action.
With 11 academic, clinical and commercial partners from Ireland, Germany, the Netherlands, Belgium, Italy and the UK, Nephstroms treatment plan has now been approved for first-in-human clinical trials.
The programme’s Phase 2a trial will investigate a stromal cell therapy procedure called Orbcel-M, which was discovered by Dr Stephen Elliman, chief scientific officer at Orbsen Therapeutics, an NUIG spin-out.
To date, this process has demonstrated “significant improvements in kidney function” in pre-clinical models of the disease, according to NUIG.
“This approval is a vital step towards the successful completion of the Nephstrom trial,” said Professor Timothy O’Brien, dean of the College of Medicine, Nursing and Health Sciences at NUIG, and the co-ordinator of the programme.
“Achieving this has involved a tremendous amount of work on the part of the whole Nephstrom team.”
The clinical trial is being led by Professor Giuseppe Remuzzi at the Mario Negri Institute in Bergamo, Italy, with clinical trial recruitment sites in Italy, Ireland and the UK.