A clinical trial for cell therapy experiments for adults with diabetes has produced encouraging findings. The NEPHSTROM clinical trial is starting to look into the potential of new cell therapy for treating adults with type 2 diabetes and increasing kidney damage despite receiving the best medical care. Results from the NEPHSTROM clinical trial were presented in November at the American Society of Nephrology’s Kidney Week meeting in Orlando, Florida.
It showed that a single dose of ORBCEL-M, given intravenously to carefully selected adults with worsening kidney disease due to diabetes was safe and associated with better preservation of kidney function compared to a placebo. Patients taking part in the trial were followed closely for 18 months after receiving ORBCEL-M.
The ORBCEL-M cell therapy is a mesenchymal stromal cell (MSC) preparation manufactured from healthy bone marrow which was discovered and developed in Galway by Orbsen Therapeutics Ltd, a spinout company from the University of Galway.
The clinical trial is being led by the Mario Negri Institute for Pharmacological Research IRCCS in Bergamo, Italy and carried out jointly at leading medical centres in Galway, Bergamo, Birmingham and Belfast.
Trial investigator Professor Matt Griffin, a senior researcher at the University of Galway's Regenerative Medicine Institute (REMEDI) and a Consultant Nephrologist at Galway University Hospitals, said, “Nearly a quarter of a million people in Ireland are living with diabetes, and we know that more than 40% of them have evidence of kidney disease - often referred to as diabetic kidney disease or DKD for short.”
He added, “In type 2 diabetes, as many as one-third of those with DKD have worsening kidney function despite the best medical therapy we can offer. These people are at high risk for requiring dialysis or kidney transplantation in the years ahead - both of which are complex treatments with potentially serious complications.”
"In NEPHSTROM, our goal is to secure evidence that cell therapy, such as ORBCEL-M, is safe and can slow the course of DKD to help more people with diabetes avoid the need for dialysis or transplantation. It was exciting to report that our first analysis of results from the trial supports that goal.”
Professor Timothy O'Brien, Director of the Regenerative Medicine Institute (REMEDI), at the University of Galway and Consultant Physician in Endocrinology at Galway University Hospitals and the overall lead of the NEPHSTROM project, said: "University of Galway's ecosystem is set up to facilitate and lead international trials of this nature. The Cell Therapy GMP manufacturing facilities at the Centre for Cell Manufacturing Ireland, located in the University, along with the HRB Clinical Research Facility, the close partnership with Saolta University Health Care Group and REMEDI have been instrumental in making the progression of this potential new therapy possible. Funding from SFI, the Higher Education Authority and the Health Research Board has supported and helped build this ecosystem and along with European Commission funding has made the advancement of this research possible.”