UC San Diego is initial site for first-in-human testing of implanted cell therapy.

Researchers at the University of California, San Diego School of Medicine, in partnership with ViaCyte, Inc, a San Diego-based biotechnology firm specializing in regenerative medicine, have launched the first-ever human clinical trial of a stem cell-derived therapy for patients with Type 1 diabetes.

The trial will assess the safety and efficacy of a new investigational drug called VC-01, which was recently approved for testing by the U.S. Food and Drug Administration. The two-year trial will involve four to six testing sites, the first being at UC San Diego, and will recruit approximately 40 study participants.

The goal, first and foremost, of this unprecedented human trial is to evaluate the safety, tolerability and efficacy of various doses of VC-01 among patients with type 1 diabetes mellitus, said principal investigator Robert R. Henry, MD, professor of medicine in the Division of Endocrinology and Metabolism at UC San Diego.

He is also chief of the Section of Endocrinology, Metabolism & Diabetes at the Veterans Affairs San Diego Healthcare System.

We will be implanting specially encapsulated stem cell-derived cells under the skin of patients where its believed they will mature into pancreatic beta cells able to produce a continuous supply of needed insulin.

Previous tests in animals showed promising results. We now need to determine that this approach is safe in people.

Development and testing of VC-01 is funded, in part, by the California Institute for Regenerative Medicine, the states stem cell agency, the UC San Diego Sanford Stem Cell Clinical Center and JDRF, the leading research and advocacy organization funding type 1 diabetes research.

Type 1 diabetes mellitus is a life-threatening chronic condition in which the pancreas produces little or no insulin, a hormone needed to allow glucose to enter cells to produce energy.

It is typically diagnosed during childhood or adolescence, though it can also begin in adults. Though far less common than Type 2 diabetes, which occurs when the body becomes resistant to insulin, Type 1 may affect up to 3 million Americans, according to the JDRF.

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UCSD Medical School Holding Clinical Trials For Stem Cell ...