An EU investigation into new treatments for diabetic kidney disease has shifted from animal testing into first-in-human clinical trials.
The pursuit of treatments for irreversible illnesses represents some of the most crucial areas of medical science. Through its Horizon 2020 programme, the EU is looking into such cases, with one in particular powering through vital landmarks.
Called Nephstrom, the international project – with NUI Galway (NUIG) as the coordinating 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, this particular illness 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. Nephstrom, so far, has been doing just that.
With 11 academic, clinical and commercial partners from Ireland, Germany, the Netherlands, Belgium, Italy and the UK, its treatment plan has now been approved for first-in-human clinical trials, kicking off this year.
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 Prof Timothy O’Brien, dean of the College of Medicine, Nursing and Health Sciences at NUIG, and the coordinator 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 Prof Giuseppe Remuzzi at the Mario Negri Institute in Bergamo, with clinical trial recruitment sites in Italy, Ireland (HRB Clinical Research Facility, Galway) and the UK (UHBFT, Birmingham and BHSCT, Belfast).