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Orbsen Therapeutics reports further clinical progress for single-dose cell therapy being developed to slow diabetic kidney disease Researchers have revealed new evidence that a single stem cell therapy treatment can slow the loss of kidney function in adults who have diabetic kidney disease. The stem cell therapy, ORBCEL-M, was developed by University of Galway spinout company, Orbsen Therapeutics, The new results come from the EU Horizon 2020-funded NEPHSTROM project, which conducted a clinical trial of this therapy as an intravenous infusion in adults with progressive chronic kidney disease due to type 2 diabetes. The early-stage trial involved two groups of patients treated with lower and higher doses of ORBCEL-M as well as a group treated with a placebo infusion. The results for these groups confirmed that a single dose of ORBCEL-M was as safe as the placebo infusion and associated with better preservation of kidney function. Patients taking part in the trial were followed closely for 18 months after receiving the therapy. These promising results could mean more time before kidney failure, more time living independently, and potentially more time before dialysis or transplant becomes necessary for adults with diabetic kidney disease. The project was completed by an international consortium led by University of Galway-including specialised researchers, medical specialists, cell manufacturing facilities and companies from Ireland, Italy, the UK, the Netherlands, Belgium and Germany. The ORBCEL-M cell therapy is a mesenchymal stromal cell (MSC) preparation manufactured from healthy bone marrow which was discovered and developed by Orbsen Therapeutics, a Galway-based clinical-stage cell therapy company which emerged as a spinout from the University of Galway’s Regenerative Medicine Institute (REMEDI). The findings from the trial support plans for a larger clinical trial to test whether a single infusion of ORBCEL-M will slow the rate at which kidney function declines in people with diabetic kidney disease and delays the need for dialysis or kidney transplantation. It is the second positive report following a clinical trial of the therapy. The latest results from the trial can be read in Kidney International Reports here. Steve Elliman, Chief Scientific Officer of Orbsen Therapeutics, said: “Publication of the first NEPHSTROM clinical report was an important milestone for Orbsen and for the NEPHSTROM consortium. Acceptance of the second clinical report adds further independent peer-reviewed support for the programme. “Most importantly, we thank the patients who took part in NEPHSTROM. Every clinical advance begins with patients who are willing to participate in carefully controlled research. These are still early studies, and ORBCEL-M must now be tested in a larger clinical trial. Taken together, the NEPHSTROM publications support the case for that next stage of development.” Matthew Griffin, Professor of Transplant Biology at University of Galway and Consultant Nephrologist at Galway University Hospitals, notes: “While the data are very encouraging, it is important to recognise that the latest results to be published from the NEPHSTROM trial do not prove benefit. Nonetheless, they do strengthen the evidence we need to move toward larger trials. If confirmed in larger studies, that could mean giving people who are at risk of kidney failure due to diabetes more healthy time at home, at work, and with their families.” Chronic kidney disease affects more than 1 in 10 adults in Ireland and is most commonly caused by type 2 diabetes. It is often a silent condition which can progress for years before a person realises anything is wrong. For people with diabetes whose kidney function is worsening despite the best treatments that can be provided, the future can be stark, including a high risk of needing kidney replacement therapies such as dialysis several times a week or kidney transplantation. In the past decade, new medicines have been discovered which have improved treatment for diabetic kidney disease. However, these medicines are taken daily or weekly and some patients still progress towards dialysis or transplant. Orbsen is seeking to test whether a single dose of ORBCEL-M can be added to these medicines to slow the loss of kidney function and keep more people with diabetic kidney disease free of kidney replacement therapy for longer. Orbsen is now seeking funding to advance manufacturing validation, regulatory preparation and the larger clinical trial required to determine whether ORBCEL-M can become a clinically meaningful disease-modifying therapy for progressive diabetic kidney disease. Ends