Islet Replacement Therapy Has Advanced in Preclinical Trials
Researchers reported new data for an experimental type 1 diabetes treatment that remains functional during storage.
Updated on Oct. 2, 2026 in Diabetes
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Century Therapeutics recently presented nonclinical findings for CNTY-813, an iPSC-derived islet replacement therapy designed to treat type 1 diabetes. The FDA has reached general alignment with the company regarding the design and manufacturing process for the upcoming human trials.
Why it matters
This development represents a potential move toward off-the-shelf islet replacement therapies that could maintain blood glucose control. It addresses critical logistical and efficacy challenges in cell-based treatments for type 1 diabetes.
In nonclinical research presented at the 62nd EASD Annual Meeting, the therapy maintained glycemic control in diabetic mice for over eleven months and retained beta cell identity in rats. These findings are preliminary as the treatment has not yet been tested in humans.
The players
Century Therapeutics
A Philadelphia-based biotechnology firm focused on developing iPSC-derived cell therapies for autoimmune and cancer indications.
FDA
The federal agency responsible for overseeing the safety and efficacy of medical products and trial designs in the United States.
EASD
The European Association for the Study of Diabetes is a professional organization that hosts annual meetings to discuss advancements in diabetes research.
The details
CNTY-813 uses Allo-Evasion 5.0 engineering technology to replace damaged pancreatic islets, which are the cells responsible for insulin production. The company developed a 29-day manufacturing process to produce consistent clinical-scale batches that remain functional after 96 hours of cold storage, potentially simplifying distribution.
Timeline
October 2, 2026: Nonclinical data was presented at the EASD Annual Meeting in Milan.
Fourth quarter of 2026: Century Therapeutics plans to submit an Investigational New Drug application.
Second half of 2027: Initial human clinical trial data is currently anticipated.
Health Landscape
This development in stem cell-derived islet transplantation builds upon the ongoing effort to create scalable, off-the-shelf treatments for type 1 diabetes. It marks a shift from experimental proof-of-concept models toward standardized manufacturing processes designed for clinical adoption.
These findings are currently limited to nonclinical research and do not impact existing treatment plans for patients with type 1 diabetes. Readers should continue to work with their endocrinologist regarding current standard-of-care options for glycemic control.
The takeaway
Advancements in cell engineering and storage stability may eventually simplify the logistics of islet replacement therapy for patients. If you are interested in future research updates, consider tracking the clinical trial progress of emerging cell-based therapies through your physician.
What happens next
Century Therapeutics plans to file an Investigational New Drug application in the fourth quarter of 2026, followed by the release of initial clinical data in the second half of 2027.
Further reading
For more on the current strategies for managing glucose regulation, visit our Diabetes section.
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