The Sanford Project

From the Summer 2017 edition of Vanderbilt Medicine Magazine

Sanford Health, in collaboration with Caladrius Biosciences, Inc., is investigating whether a child’s own cells can fight type 1 diabetes. This clinical trial, known as The Sanford Project: T-Rex Study, studies an innovative investigational therapy in children newly diagnosed with type 1 diabetes. Vanderbilt is one of 15 sites participating in the trial.

Researchers focus specifically on children’s Treg cells, which may help stop the immune system’s attack on the body’s insulin-producing beta cells. The Treg cells will be collected from the participants’ blood, grown in a lab to make more of them, and returned back into their blood circulation.

Immune System Balance

Researchers are testing whether these expanded Treg cells can rebalance the immune system and stop the attack on beta cells.

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Four Steps to More Tregs

Treg cells are harvested from a study participant’s blood, then multiplied in a laboratory to create an investigational treatment called CLBS03. The CLBS03 is then given back to the same patient intravenously.

STEP 1

Blood is taken from the patient

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STEP 2

Treg cells are separated from blood

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STEP 3

In a lab, Treg cells are grown to make more Treg cells

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STEP 4

New Treg cells are returned to the patient

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Trial Design

This trial is the first for this therapy in the United States to enroll adolescents. To enroll, participants must be at a minimum 8-17 years old and have been diagnosed with diabetes in approximately the last two months.

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A randomized, placebo-controlled, double-blind Phase 2 trial

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Includes more than 100 children across 15 sites in the United States

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Could take two years or more to complete

Timeline for Trial

* Follow-up visits include: four visits in first month following the infusion procedure, then six visits over the following two years.

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