Breaking New Ground: Landmark Clinical Trial Opens Islet Cell Transplants to Type 1 Diabetes Patients with Chronic Kidney Disease

In a milestone development for diabetes research, a newly launched clinical trial is breaking decades of medical precedent by offering islet cell transplants to individuals living with both type 1 diabetes (T1D) and chronic kidney disease (CKD). Funded by Breakthrough T1D and utilizing Eledon Pharmaceuticals’ targeted immunotherapy drug, tegoprubart, this multi-center study marks the first time that patients with compromised renal function are formally eligible for islet cell replacement therapy. The trial has already achieved a crucial operational milestone, with its first enrolled participant successfully receiving a transplant.

The Convergence of Type 1 Diabetes and Chronic Kidney Disease

Type 1 diabetes is a chronic autoimmune condition characterized by the destruction of insulin-producing beta cells in the pancreas, requiring lifelong insulin replacement therapy. Over time, sustained hyperglycemia can lead to severe microvascular and macrovascular complications. Among the most debilitating of these is chronic kidney disease, which affects a significant proportion of the T1D population. Historically, the presence of CKD served as an absolute contraindication for islet cell transplantation.

The primary barrier has centered on the immunosuppressive regimens required to prevent graft rejection. Standard post-transplant care heavily relies on calcineurin inhibitors, most notably tacrolimus. While effective at preventing the immune system from attacking foreign islet cells, tacrolimus carries well-documented nephrotoxic side effects. For a patient whose kidney function is already impaired by diabetic nephropathy, administering a drug known to damage renal tissue posed an unacceptable medical risk. Consequently, hundreds of thousands of patients burdened by both T1D and advanced kidney complications were systematically excluded from life-changing cell therapy trials.

The Role of Tegoprubart in Overcoming Immunosuppressive Toxicity

The foundation of the current trial rests on years of pharmacological development aimed at finding safer, more targeted alternatives to conventional immunosuppression. Tegoprubart is an investigational immunotherapy designed to block specific pathways involved in immune system activation without inflicting the systemic toxicity associated with older drugs. By neutralizing the immune response directed against transplanted islets while sparing renal tissue, tegoprubart effectively removes the historical roadblock that locked CKD patients out of beta-cell replacement therapies.

This clinical trial builds directly upon earlier success observed in separate Breakthrough T1D-backed studies evaluating tegoprubart alongside deceased-donor islet cell transplants. In those preceding trials, involving individuals with severe hypoglycemic events and hypoglycemia unawareness, the therapeutic approach yielded remarkable results: all initial participants achieved insulin independence free from significant adverse side effects. Having established the viability of tegoprubart in patients with healthy kidney function, researchers and sponsors quickly turned their attention toward expanding the therapeutic window to include those with kidney impairment.

Trial Design, Participant Criteria, and Institutional Collaboration

Designed as a multi-center study, the current clinical trial is actively enrolling up to 10 participants across two premier medical institutions: the University of Chicago and the University of Miami. The financial engine behind this initiative is a substantial $8.5 million research grant awarded by Breakthrough T1D to the University of Chicago. Additionally, Eledon Pharmaceuticals operates as a portfolio company of the T1D Fund, reinforcing the tight network of philanthropic and biotech entities driving the research forward.

To qualify for the study, participants must present with established type 1 diabetes complicated by chronic kidney disease, placing them outside the eligibility parameters of traditional transplant protocols. Rather than receiving a standard regimen containing tacrolimus, trial participants are administered tegoprubart as part of a calcineurin inhibitor-free immunosuppression protocol designed to protect residual kidney function while preventing graft rejection.

Researchers have established rigorous endpoint measures to evaluate the success of the intervention at the one-year post-transplant mark. Primary metrics include the proportion of participants who achieve complete independence from exogenous insulin therapy, maintenance of glycated hemoglobin (HbA1c) levels below 7%, and the total elimination of severe hypoglycemic episodes as verified through continuous glucose monitoring (CGM) technology.

Perspectives from Leadership and the Broader Research Community

The launch of the trial has elicited strong reactions from prominent figures within the medical and philanthropic communities, who view the study as a crucial pivot point in regenerative medicine for endocrine disorders.

"Advancing promising islet cell research that is a next step toward durable and scalable cures for type 1 diabetes is a key priority for Breakthrough T1D," stated Esther Latres, Ph.D., Senior Vice President of Research at Breakthrough T1D. "We’re proud to support this trial that expands cell therapy research and access to people living with T1D and chronic kidney disease for the first time."

Medical analysts note that the implications of this trial extend far beyond the initial cohort of 10 participants. If tegoprubart proves both safe and effective in preserving kidney function while maintaining graft survival, it could fundamentally rewrite clinical guidelines for transplantation medicine. By decoupling islet transplantation from nephrotoxic immunosuppressants, the medical community moves closer to a future where cellular therapies are accessible to a broader demographic of patients, regardless of secondary end-organ damage.

Strategic Alignment with Project ACT and Future Horizons

This trial represents a core operational pillar within Breakthrough T1D’s Project ACT initiative, a strategic framework dedicated to accelerating the development and commercialization of beta-cell replacement therapies. The ultimate objective of Project ACT, and the broader roadmap published by the organization, is to minimize or entirely eliminate the need for chronic immunosuppression. Achieving this goal would transform islet transplantation from a high-risk, highly specialized procedure into a widely accessible, scalable functional cure for type 1 diabetes.

As the first participant in the University of Chicago and University of Miami study progresses through the post-transplantation monitoring phase, clinical investigators and data safety committees will closely track both metabolic control and renal markers. The results yielded by this trial will likely serve as a decisive benchmark, informing future regulatory submissions and shaping the next generation of immunotherapy-assisted cell replacement trials worldwide.