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Gene-Edited islet cells produce insulin beyond 14 months less immunosuppression: milestone raises bigger questions. Listen ~2 min TrialSite Staff | Making Biomedical Research Evidence Accessible to All Jul. 14, 2026, 9:00 a.m. A first-in-human study at Uppsala University Hospital, led by principal investigator Per-Ola Carlsson, reports that gene-edited donor islet cells continue producing insulin more than 14 months after transplantation in a patient with longstanding type 1 diabetes (T1D) - without chronic immunosuppressive drugs. The findings, now detailed in the New England Journal of Medicine, represent one of the strongest clinical demonstrations to date that genetically engineered "hypoimmune" cells may evade immune rejection while remaining functional. The study findings. The investigator-sponsored Phase 1 study enrolled a single adult with T1D who received genetically modified deceased-donor pancreatic islets transplanted into the forearm muscle. Only about 5% of the islet mass typically required to restore insulin production was implanted, emphasizing that the trial's primary objective was safety and proof of concept rather than insulin independence. After 60 weeks, investigators reported no serious treatment-related adverse events, persistent glucose-responsive C-peptide production, no detectable immune rejection, and imaging evidence that the transplanted cells remain viable. The investigational therapy. The technology originates from Sana Biotechnology (NASDAQ: SANA), a Seattle-based biotechnology company developing engineered cell therapies designed to evade immune detection. Sana now plans to advance SC451, a stem cell-derived, hypoimmune islet therapy intended to provide a scalable, one-time treatment for T1D without lifelong immunosuppression. Early stages. The implications are significant - but so are the unanswered questions. Can immune evasion remain durable for years? Will larger doses restore insulin independence? Could engineered hypoimmune cells increase long-term infection or malignancy risks? And perhaps most importantly, can this highly personalized proof-of-concept be manufactured consistently at commercial scale while satisfying increasingly rigorous regulatory standards? Quality journalism costs money to produce. Subscription options start at $5 per month which is less than a Starbucks coffee!

New publication: Sana's gene-edited islets continue to make insulin. July 13, 2026 Read more in: What's happening? A new publication in The New England Journal of Medicine provides more detail about the first person with type 1 diabetes (T1D) treated with Sana Biotechnology's gene-edited islets. This person is still making insulin 14+ months after their islet transplant - without immunosuppressants! What to know about Sana's gene-edited islets. Sana's novel cell therapy approach is designed to help transplanted islet cells evade immune attack while continuing to produce insulin. The strategy uses gene editing to create hypoimmune islet cells, which are cells engineered to avoid detection by the immune system while maintaining their insulin-producing function. This approach is one of several next-generation cell therapy strategies being prioritized by Breakthrough T1D to help overcome one of the biggest barriers to cell replacement therapies: immune rejection. In this first-in-human study, deceased-donor islets were genetically modified to become immune-evasive and then transplanted into the forearm. Because this is a phase 1 trial, the primary goal is to assess safety, while also monitoring islet function through C-peptide, a marker of the body's own insulin production. Importantly, the transplant included only about 5% of the number of cells typically needed to fully restore insulin production, reflecting the exploratory nature of the study. The results so far. The results so far are encouraging. After 60 weeks, there have been no severe adverse events, meeting the trial's primary safety endpoint. At 14 months after transplantation, the participant continued to produce detectable C-peptide, indicating that the transplanted cells remained alive and functional. The islet cells were also visible in the participant through PET and MRI imaging. Researchers also observed that C-peptide levels temporarily declined after about one year, likely due to beta cell exhaustion, but subsequently recovered. This is an encouraging signal that the transplanted cells may be capable of regaining function. Importantly, the participant had no detectable immune response to the transplanted islet cells. While the levels of T1D autoantibodies remained unchanged, this had no impact on the survival and function of the gene-edited islets. What's coming next. While still very early, these findings provide important proof of concept that gene-edited, immune-evasive islet cells can survive and function in a person with T1D. If confirmed in larger studies, this approach could help move the field closer to cell therapies that work without long-term immune suppression - a major goal for the future of T1D cures. Excitingly, Sana plans to translate their hypoimmune gene-editing technology to manufactured islets in a new clinical trial, meaning that they are combining their unique immune protection strategy with a scalable approach. This is in line with its Project ACT initiative, which aims to dramatically speed development, access, and adoption of islet cell therapies for everyone with T1D who wants them. Project ACT Scientific progress takes time, resources, collaborations, and effort. To get islet cell therapies to people with T1D faster than ever, Breakthrough T1D launched Project ACT (Accelerate Cell Therapies) to simultaneously advance research, development, regulatory policies, access, and adoption of islet cell therapies that do not require broad immunosuppression. Driving research into T1D Cell Therapies. Sana is a portfolio company of the T1D Fund: A Breakthrough T1D Venture. Through equity investments, Juvenile Diabetes Research Foundation International Inc. has helped Sana grow their T1D pipeline, leading to their gene-edited islet cell therapy being investigated in human clinical trials. Even more, the T1D Fund recently invested in Century Therapeutics, another company developing manufactured islet cell therapies with immune-evasive capabilities. Juvenile Diabetes Research Foundation International Inc. will continue to work closely with Sana and other promising companies to support their product development and accelerate scalable islet cell therapy approaches that do not require immunosuppression.

Sana Biotech heads to EASD with diabetes cell therapy update. Company to spotlight clinical progress on immune-evasive cell therapy that could reshape regenerative medicine for type 1 diabetes. What if the biggest breakthrough in treating type 1 diabetes isn't replacing the cells that make insulin but convincing the body to simply leave them alone? For many people living with type 1 diabetes (T1D), replacing lost insulin-producing cells has always sounded like the obvious answer. The problem is that the immune system often sees those new cells as intruders and destroys them, forcing transplant recipients onto lifelong immunosuppressive drugs. For some patients, that trade-off can feel almost as burdensome as managing diabetes itself. That is why Sana Biotechnology's upcoming appearance at the European Association for the Study of Diabetes (EASD) Annual Meeting 2026 deserves attention. The company will present clinical findings from its first-in-human study of UP421, an experimental cell therapy designed to keep transplanted insulin-producing cells "hidden" from the immune system - without requiring immunosuppression [1]. Teaching transplanted cells to wear a disguise. Imagine trying to introduce a new player onto a sports team while the referees insist they don't belong. No matter how talented they are, they'll be sent off the field before they can contribute. That is essentially what happens after most cell transplants. The body's immune system is remarkably good at identifying anything it considers foreign. It protects First Longevity Ltd. from viruses and bacteria, but it also attacks transplanted cells, even when those cells could restore lost function. Sana's Hypoimmune Platform (HIP) attempts to solve this by giving donor cells what amounts to a biological disguise. Instead of suppressing the patient's immune system, the company engineers the transplanted cells themselves to become far less visible to immune attack. The approach flips decades of transplant medicine on its head. Rather than weakening the body's defenses, it teaches replacement cells how to coexist with them. The EASD presentation builds on results Sana shared earlier this year from the same first-in-human study. After 14 months, researchers reported that the transplanted insulin-producing cells were still alive, continued producing insulin and showed no safety concerns - all without immunosuppressive medication [2]. Those findings matter because the study was never designed to prove that patients could stop taking insulin altogether. Instead, it asked a more fundamental question: can engineered donor cells survive inside the body without being rejected? So far, the answer appears encouraging. Researchers also observed something more subtle. Between months 12 and 14, the participant achieved tighter blood glucose control. As glucose levels improved, the transplanted cells responded by producing more insulin, as measured by C-peptide, a marker of endogenous insulin production. Think of it like a thermostat responding to the temperature in a room. Healthy pancreatic cells constantly adjust to what the body needs. Seeing transplanted cells respond dynamically hints that they may be behaving more like living tissue than static implants. That distinction could prove just as important as their survival. An unexpected address for new pancreatic cells. Perhaps the most surprising aspect of the study is where these cells are living. Traditional islet cell transplants are typically infused into the liver through the portal vein, a technically demanding procedure requiring specialized expertise. Sana's investigators instead transplanted the engineered cells into a forearm muscle. More than a year later, imaging continued to detect the transplanted cells at the site. It is still early, and no one is suggesting that forearm transplantation will immediately replace existing procedures. However, the idea raises intriguing possibilities. If future studies confirm similar results at larger scales, localized implantation could eventually become a simpler and potentially more accessible way to deliver regenerative therapies. Sometimes innovation is not only about changing the treatment, but changing where and how it's delivered. Beyond one disease. The announcement itself is modest: Sana will present its findings during a symposium titled Stem cell-derived islets in clinical trials: towards a cure for type 1 diabetes at EASD in Milan on October 2. Yet the implications extend well beyond diabetes. The same immune rejection that complicates islet transplantation also limits efforts to replace damaged cells in numerous diseases. If engineered cells can reliably avoid immune attack without compromising the patient's own immune defenses, the technology could become a platform for regenerative medicine rather than a solution for a single condition. That is also why Sana is developing SC451, a stem cell-derived therapy that applies the same immune-evasion technology with the goal of making treatment more scalable in future clinical trials. For longevity researchers, this represents an important shift in thinking. Extending healthspan increasingly depends not only on slowing damage but on repairing it. The ability to replace worn-out or diseased cells and have them remain functional for years could become one of the defining technologies of healthy aging. Three questions worth watching. As Sana heads to EASD, the upcoming presentation is likely to spark discussion far beyond endocrinology. Can immune-evasive cells finally free transplant recipients from lifelong immunosuppressive drugs? Could a forearm muscle become an unexpectedly practical home for insulin-producing cells, making future procedures simpler than today's liver transplants? And perhaps most intriguingly, does the ability of these transplanted cells to adjust insulin production as glucose levels improve suggest they are beginning to behave less like engineered products and more like living organs? None of those questions has definitive answers yet. Nonetheless, these questions point toward something larger than a diabetes story. They reflect a future in which regenerative medicine is about helping replacement cells integrate so naturally that the body treats them as its own. If that future arrives, longevity may depend not just on living longer, but on teaching its cells (and its immune systems) to live together. LTUI: 2581 Sana Biotechnology. Powered by: Longevity level(s): * Level 6: Aging disease prevention therapeutics * Level 7: Targeted aging disease reversal Overview. Sana Biotechnology is a clinical-stage biopharmaceutical company focused on developing engineered cells as medicines to address the underlying causes of disease. The company operates two primary platforms: ex vivo cell replacement therapies targeting conditions such as type 1 diabetes through insulin-producing islet cell transplantation, and in vivo cell engineering for gene repair and modification in patients with inherited genetic disorders and acquired diseases. Sana's approach integrates advances in stem cell biology, immunology, and gene editing technologies to create scalable, accessible cellular therapeutics across diverse therapeutic areas including oncology, autoimmune disorders, and metabolic diseases. Access all data points on DLT: * Financial Data * Patents * Technology * Management * Advisory Board * News * Classifications * Similar Companies