The grudge of receiving robust medical care, adults with type 2 diabetes are still developing kidney damage, and the NEPHSTROM clinical study is just started to inspect the probability of the new cell therapy to treat them.
In November the results of the NEPHSTROM clinical trial were presented in the meeting which was held at the American Society of Nephrology’s Kidney Week in Orlando, Florida. The result appeared that a single dose of ORBCEL-M, given intravenously to adults with damaged kidney disease due to diabetes was safe and associated with better preservation of kidney function as compared with a placebo. Adults who took part in this trial were followed closely for 18 months after receiving ORBCEL-M.
Orbsen Therapeutics Ltd, a spin-out company from the University of Galway; discovered & developed this ORBCEL-M cell therapy which is a mesenchymal stromal cell manufactured from healthy bone marrow.
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 centers in Galway, Bergamo, Birmingham, and Belfast.
“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. For type II diabetes, as many as 1/3rd of those with DKD have worsening kidney function despite the best medical therapy we can offer. People are at high risk for requiring dialysis or kidney transplantation in the year 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 as transplantation. It was exciting to report that our first analysis of results from the trial supports that goal”. Said professor Matt Griffin (senior researcher at the University of Galway’s Regenerative Medicine institute and a Consultant Nephrologist a Galway University Hospitals.
Dr. Steve Elliman, who discovered the ORBCEL-M therapy, and chief scientific officer for Orbsen therapeutics said: “At Orbsen Therapeutics we are motivated by improving patient care, diabetic patients with progressive kidney disease eventually require dialysis 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. Additionally, dialysis takes four hours per session and three times a week- creating logistic and economic challenges for the patient. Our goal with ORBCEL-M is to resolve systematic inflammation and improve kidney function, so that patients will not require dialysis or a kidney transplant. We’re encouraged by the safety profile and the preliminary efficacy signals in patients with DKD reported by the NEPHSTROM trial. We look forward to continued collaboration with our University of Galway and NEPHSTROM partners to advance this new medicine through Phase 3 efficacy trials and market approval.”
“Without patient involvement in clinical trials, advances in new treatments are simply not possible. We are fortunate to have the HRB clinical research facility Galway, a clinically equipped space to see and treat patients on trials. We are hopeful that future generations will benefit from the willingness of patients to participate in trials, such as the NEPHSTROM trial”. Pointed out by Dr. Veronica Mclnerney, an Administrative Director at the HRB Clinical Research Facility at the University of Galway.
Director of the Regenerative Medicine Institute, at the University of Galway Consultant Physician in Endocrinology at Galway University Hospital and the overall lead of the NEPHSTROM project, Professor Timothy O’Brien 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 center 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.”
