A study investigating whether the cells of a child can fight their own type 1 diabetes has reached a major milestone.
The Sanford Project: T-Rex Study is one of a number of exciting new studies looking to develop a therapy for children who are newly diagnosed with type 1 diabetes. It is now at the halfway stage for enrolment and treatment.
Phase II of the T-Rex Study is being led by Caladrius Biosciences and Sanford Health as part of the Sanford Project, set up thanks to a $400 million investment from philanthropist Denny Sanford back in 2007.
The exploratory therapy involves Treg cells, a group of cells which could hold the key to preventing the body from destroying the beta cells which produce insulin. Treg cells are sometimes called Tregs, pronounced tee-regs, which is where the link to the dinosaur T-Rex developed.
Scientists are harvesting Treg cells from the study participants and then growing them in a laboratory before returning the cells and placing them into the blood circulation of the same participant.
Dr Kurt Griffi, who is the Sanford Project’s director of clinical trials, said: “People with type 1 diabetes tend to have fewer Treg cells, and those they do have don’t work as well. We want to increase the number of cells and improve their function to stop the attack on the beta cells that make insulin.
“I’m excited to have enrolled the first cohort so quickly at the two Sanford sites, to have reached the halfway point of the study and to continue to contribute to enrolling the second half of participants.”
Youngsters aged between eight and 17 who have been diagnosed with type 1 diabetes in the last 100 days are being studied.
In reaching the halfway point, 56 of the people involved in the study have been treated out of the 111 taking part, with study participants having been collected from 12 sites across America.
The findings of an interim analysis looking into early progress of the treatment are due to be published either at the end of the year or at the beginning of 2018.

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