Body’s own cells are focus of type 1 diabetes clinical trial

Sanford Health is collaborating with Caladrius Biosciences, Inc., a New Jersey-based cell-therapy company, on a clinical trial that explores whether increasing the number of a person’s regulatory T cells (Treg cells) can help adolescents fight newly onset type 1 diabetes.

The trial, known as “The Sanford Project: T-Rex Study” (NCT02691247), tests the safety and effectiveness of a product manufactured by a technique that purifies and multiplies the body’s own Treg cells. Treg cells are grown in culture in a lab to dramatically multiply their numbers before they are returned to the donor via infusion. Researchers will monitor whether this type of immunotherapy could preserve beta cell function.

Type 1 diabetes is an autoimmune disease characterized by a loss of insulin-producing beta cells. Treg cells function to temper the body’s immune responses. Because people with type 1 diabetes have fewer Treg cells, boosting their numbers may help rebalance the body’s immune system.

“The body’s own immune system can be a very effective tool in fighting disease, and most of the time it recognizes our bodies as something to leave alone,” said Kurt Griffin, Ph.D., M.D., director of clinical trials for The Sanford Project. “Type 1 diabetes is an example of this ‘tolerance of self’ being lost and the immune system causing damage. If we can rebalance the immune system and stop the body from attacking its own beta cells, we hope to preserve insulin production.”

Type 1 diabetes is the focus of The Sanford Project, a cornerstone research initiative at Sanford Research.

“The use of regenerative medicine and immunotherapy in health care isn’t just a trend in medicine, it will soon be the standard of care,” said David Pearce, Ph.D., president of Sanford Research. “Sanford’s collaboration with Caladrius provides children with type 1 diabetes access to what we hope is the next generation treatment and cure for this disease.”

Participants in The Sanford Project: T-Rex Study must be 12 to 17 years old and have been diagnosed with diabetes in approximately the last two months. The trial opened in February.

Sanford enrollment locations include Sioux Falls and Fargo, North Dakota. For more information or to enroll, call 855-305-5059.

About Sanford Health
Sanford Health is an integrated health system headquartered in the Dakotas. It is one of the largest health systems in the nation with 43 hospitals and nearly 250 clinics in nine states and three countries. Sanford Health’s 27,000 employees, including 1,400 physicians, make it the largest employer in the Dakotas. Nearly $1 billion in gifts from philanthropist Denny Sanford have allowed for several initiatives, including global children’s clinics, genomic medicine and specialized centers researching cures for type 1 diabetes, breast cancer and other diseases. For more information, visit

About Caladrius Biosciences, Inc.
Caladrius Biosciences, Inc., through its wholly-owned subsidiary, PCT, is a leading development and manufacturing partner to the cell therapy industry. Caladrius works with its clients to overcome the fundamental challenges presented by cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. Around this core expertise, Caladrius strategically develops product candidates, which currently include an innovative therapy for type 1 diabetes based on a proprietary platform technology for immunomodulation, and holds intellectual property around other cell therapy platform technologies. For more information, visit

Posted In Endocrinology, News