Type 1 Diabetes Cell Therapy Trial Enrolls First Patient at Sanford

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Sanford, Caladrius trial is using immunotherapy

Kurt Griffin, Ph.D., M.D.

The enrollment of the first patient in The Sanford Project: T-Rex Study demonstrates Sanford’s commitment to bringing cutting-edge research and next generation treatments to our region.

A clinical trial studying the body’s ability to type fight 1 diabetes using cell therapy has used the method on its first participant. “The Sanford Project: T-Rex Study” is a collaborative study between Sanford Health and Caladrius Biosciences, Inc., for adolescents with newly onset type 1 diabetes.

Type 1 diabetes, an autoimmune disease characterized by a loss of insulin-producing beta cells, is the focus of The Sanford Project, a cornerstone research initiative at Sanford Research.

Investigators in this trial are studying the effectiveness of cell therapy with expanded regulatory T cells, or Treg cells, to treat type 1 diabetes. Treg cells regulate the body’s immune system. A participant’s own Treg cells are extracted from the body, purified and multiplied and returned to blood circulation. Researchers are monitoring if beta cells and insulin production can be preserved through this type of immunotherapy.

“The enrollment of the first patient in The Sanford Project: T-Rex Study demonstrates Sanford’s commitment to bringing cutting-edge research and next generation treatments to our region.” said Kurt Griffin, Ph.D., M.D., director of clinical trials for The Sanford Project. “Leveraging the body’s own natural mechanisms is a particularly appealing approach.”

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.

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 sanfordhealth.org.

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 http://www.caladrius.com.

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Tim Gerszewski
Sanford Health
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