Researchers have reported positive results from a unique cell treatment experiment for adults with diabetes.
Despite receiving robust medical care, adults with type 2 diabetes are developing kidney damage, and the NEPHSTROM clinical study is examining the possibilities of a new cell therapy to treat them.
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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.
ORBCEL-M cell therapy is a mesenchymal stromal cell (MSC) preparation manufactured from healthy bone marrow that was discovered and developed in Galway by Orbsen Therapeutics Ltd., a spinout company from the University of Galway.
The clinical trial is being led from 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.
"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. They are at high risk of requiring dialysis or kidney transplantation—both of which are complex treatments with potentially serious complications.
Dr Steve Elliman, who discovered the ORBCEL-M therapy, is the Chief Scientific Officer for Orbsen Therapeutics. Dr Elliman said: “Diabetic patients with progressive kidney disease eventually require dialysis and often a kidney transplant. While dialysis improves the quality of life of patients with kidney failure, it is expensive and does not prevent further decline of kidney function.
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"Additionally, dialysis takes four hours per session and three times a week— creating logistical and economic challenges for the patient. Our goal with ORBCEL-M is to resolve systemic inflammation and improve kidney function, so that patients will not require dialysis or a kidney transplant. We are encouraged by the safety profile and the preliminary efficacy signals in patients with DKD reported by the NEPHSTROM trial.”