Novel therapy for diabetic kidney disease
Diabetes is the leading cause of chronic kidney disease. Diabetic kidney disease (DKD) develops in about 40 % of patients with diabetes. Associated with a high mortality rate, DKD frequently leads to kidney failure since there’s currently no effective cure for the disease. At the last stage of chronic kidney disease – end-stage renal disease – kidneys only function at 10-15 % of their normal capacity and are unable to filter wastes and excess fluid from a patient’s blood. To remain alive at this stage, patients need dialysis or a kidney transplant. However, these treatments are costly and they aren’t a guarantee against kidney failure. The EU-funded project NEPHSTROM was launched to test and validate a novel stem cell therapy called ORBCEL-M for DKD. Mesenchymal stromal cell immunotherapy is a promising treatment that has the potential to prevent or delay kidney failure by enhancing organ repair and regeneration. Preclinical experiments conducted by project partners showed that ORBCEL-M is capable of significantly improving kidney function in animals with DKD. They are now conducting a clinical trial to test the therapy’s safety and efficacy in human patients with DKD. “Encouraged by the promising results of the pre-clinical models, we are optimistic taking ORBCEL-M to the next stage to further investigate the immunotherapy as a solution to slow or stop progressive diabetic kidney disease,” said Chief Scientific Officer Steve Elliman of project partner Orbsen Therapeutics in a news item posted on the NEPHSTROM website. The second-generation stromal cell immunotherapy yields close to 100 % pure stromal cells, demonstrating a marked increase in purity when compared with first-generation stromal cell therapies. Multi-centre clinical trial The clinical trial is being conducted at four primary sites: the Mario Negri Institute (Italy), the National University of Ireland (Ireland), the University Hospitals Birmingham NHS Foundation Trust, and the Belfast Health and Social Care Trust (United Kingdom). During this early-stage clinical trial, 48 Type 2 diabetes patients with progressive DKD are being recruited to take part in a double-blind, placebo-controlled study. Patients will be randomised into 4 groups of 12, consisting of a control group and 3 groups receiving a low, medium or high dose of stem cell treatment. Although the trial’s primary aim is to verify the safety of the various stem cell doses, the researchers also hope to see a change in important disease markers. This would show that the therapy isn’t only safe but also effective. “We are pleased the NEPHSTROM clinical trial has commenced and that randomized diabetic patients with kidney disease whose previous therapies failed now are receiving ORBCEL-M™ immunotherapy,” said Orbsen Therapeutics CEO Dr Larry Couture in the same news item. “The study may be a breakthrough moment for patients with end-stage renal disease caused by diabetes.” If the NEPHSTROM (Novel Stromal Cell Therapy for Diabetic Kidney Disease) clinical trial succeeds in demonstrating the therapy’s safety, it will lead to a more advanced trial with a larger population focusing on treatment efficacy. A therapy that prevents DKD progression gives patients a longer lifespan and better quality of life, and leads to substantial cost savings for overburdened healthcare systems. For more information, please see: NEPHSTROM project website
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