Enrolment is complete for the T-Rex study into type 1 diabetes

Benedict Jephcote
Tue, 20 Feb 2018
Enrolment is complete for the T-Rex study into type 1 diabetes
Recruitment for a major study looking at whether a child's own cells can fight type 1 diabetes has reached its full quota.

The enrolment of 110 children is for the Sanford Project: T-Rex Study. The aim is to look at whether a certain type of cell therapy can rectify the immune system, ensuring insulin production continues. The participants, aged between eight and 17, must have been recently diagnosed with the condition to be eligible.

The two-year study, being held across 13 sites in America, will involve collecting regulatory T cells, otherwise known as T-reg cells, from the young subjects' blood. T-regs play an important role within the body as it is their job to regulate the immune system and prevent autoimmune diseases, such as type 1 diabetes.

Once gathered, the research team will purify and grow more T-reg cells in their lab and then return them to the child's system. A series of 10 follow-up visits will then be carried out to monitor whether the newly grown cells positively impacted the individual's type 1 diabetes.

Dr Kurt Griffin, director of clinical trials for The Sanford Project, said: "I am thrilled to have reached this important milestone. It has taken a tremendous amount of work from a large team to get this far. We still have another year of follow-up before we can really see how this treatment may be working."

David Mazzo, president and chief executive officer of Caladrius Biosciences, that is involved in the research, stated: "This program is supported by earlier work conducted by leaders in the field who demonstrated T-reg cell therapy to be well tolerated, durable and preserving of beta cell function in children.

"We look forward to reporting the topline data from the primary endpoint of the completed study in early 2019."
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