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Sanford Diabetes Trial Reaches Full Enrollment

Mar 29, 2018 06:00AM ● By MED Editor

In February, The Sanford Project: T-Rex Study, a Phase 2 clinical trial on diabetes in children, enrolled the last of its 110 trial participants. The project is studying the potential of a cell therapy developed by Caladrius that uses each patient’s own regulatory T cells, or Tregs, to fight type 1 diabetes.

Kurt Griffin, MD, PhD, director of clinical trials for The Sanford Project, says reaching full enrollment is a critical milestone for the project. “If we look at clinical trials in general, there are many of them that never actually fill,” Griffin told MED. “In other cases, a trial will take so long to fill that it isn’t even relevant anymore. It is still a long way from having the answer, but reaching full enrollment essentially tells us that we are going to get there.”

Now that the T-Rex Study trial is officially full, Griffin says “the clock starts ticking” toward the primary endpoint, which is the last year of treatment for the last enrolled child.

In the initial safety testing phase of the trial, between March and August of 2016, 18 children were enrolled at Sanford in Fargo and Sioux Falls. After a six-month pause to ensure there were no adverse events, the trial was opened for broader enrollment. Children between 8 and 18 from 13 sites are now enrolled.

“The whole idea behind this trial is to try to fill a gap and rebalance the immune system in these children,” says Dr. Griffin. Participants between 8 and 18 at 13 sites 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 in an effort to slow the decline of insulin production.

Griffin says this trial represents the first time this type of autologous immune cell transplant has been tried in diabetic children. The therapy has received fast track designation from the FDA, a first for any type 1 diabetes intervention. If the study produces positive results, the next goal will be to expand it to include younger children.

“By the time someone shows up with high blood sugar, you have already killed off most of your beta cells,” says Dr. Griffin. “The immune processes continue to accelerate and expand. If we can catch this earlier, the immune system might be more amenable to a gentle nudge in the right direction and have better effect.”

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