Breakthrough therapies are redefining type 1 diabetes management, offering new hope for patients at high risk of severe hypoglycemia. Results from the FORWARD study evaluating zimislecel, an allogeneic stem cell-derived islet therapy, were presented at the European Association for the Study of Diabetes Conference 2025.
The single-arm, open-label study included adults with impaired hypoglycemia awareness and recurrent severe hypoglycemic episodes. Participants received zimislecel via a single infusion alongside a steroid-free immunosuppression regimen and used continuous glucose monitoring throughout the study.

Among 12 participants followed for one year, ten achieved insulin independence. Hemoglobin A1c dropped from 7.8% at baseline to 6.0%, while time-in-range improved from 49.5% to 93.3%. Time-above-range decreased from 30.1% to 6.0%, and time-below-range dropped from 1.7% to 0.3%. Glycemic variability also improved substantially. No serious adverse events were linked to zimislecel, and the therapy’s safety profile remained consistent with expected immunosuppression and infusion procedures. 

These findings highlight the transformative potential of zimislecel in reducing the burden of insulin therapy and improving glucose control in type 1 diabetes.