Type 1 Diabetes Trial at Sanford Health Reaches Full Enrollment
The definition of type 1 diabetes is when your immune system destroys cells in your pancreas called beta cells. They’re the ones that make insulin.
Recently Sanford Health announced that a clinical trial studying type one diabetes has reached full enrollment. The Sanford Project: T-Rex Study, a Phase 2 clinical trial, has completed enrollment of 110 children with type 1 diabetes.
The study started with two sites at Sanford Health in Sioux Falls, South Dakota, and Fargo, North Dakota, and expanded to 13 additional sites across the United States. Subjects will be followed for two years, with the primary endpoint of persistence of insulin production at one year after treatment. A planned, interim analysis of the first half of the participants at six months after treatment is expected by the end of the first quarter.
The Sanford Project: T-Rex Study is exploring whether expanding the body’s supply of Treg cells can rebalance the immune system, stop destruction of beta cells and preserve insulin production. Participants were randomized to either of two doses in the treatment arms or to placebo. For those in the treatment groups, the participant’s own Treg cells were extracted from the body, purified, expanded in culture, and returned to blood circulation.
The therapy being used in this trial has received fast track designation from the U.S. Food and Drug Administration (FDA), a first for any type 1 diabetes intervention. That designation is reserved for drugs or biologics that address a serious health condition, like type 1 diabetes, where there is an unmet medical need.