CTRI Clinical Coordinator Todd May.
Clinical Trial Tests Safety of Investigational Drug for Type 1 Diabetes
September 15, 2014 – UC San Diego Clinical and Translational Research Institute (CTRI) is providing clinical coordinator services and clinical trial space for a first-ever human Phase I/II clinical trial of a stem-cell-derived therapy for Type 1 diabetes. The trial, launched by researchers at UC San Diego School of Medicine, in partnership with ViaCyte, Inc., tests the safety and efficacy of a new investigational drug called VC-01.
CTRI is responsible for clinical coordination of the trial and will provide space for it at the Center for Clinical Research (CCR). CTRI clinical coordinator Todd May is handling subject recruitment and all study procedures, working closely with principal investigator Robert R. Henry, MD, professor of medicine in the Division of Endocrinology and Metabolism at UC San Diego and chief of the Section of Endocrinology, Metabolism & Diabetes at the Veterans Affairs San Diego Healthcare System.
May will recruit, screen, and enroll trial participants, facilitate informed consent, conduct study visits, monitor participants, and communicate with the trial sponsor, the principal investigator, and other members of the research team. "The majority of the clinical trial will take place at CTRI's CCR," said May, who will also be in the operating room at Thornton Pavilion when four pre-filled stamp-sized capsules of VC-01 are implanted in the flank area of each trial participant. The mesh-like capsules contain stem cells that are anticipated to mature into cells that produce insulin. In Type 1 diabetes, the pancreas produces little or no insulin.
"It is really exciting to be involved in this first-in-human testing of an implanted cell therapy, which has the potential to profoundly change the way we treat Type 1 diabetes, as well as a host of other diseases," said May.
Click here to read the UCSD news release
About UC San Diego Altman Clinical and Translational Research Institute:
UC San Diego Altman Clinical and Translational Research Institute (ACTRI) is part of a national Clinical and Translational Science Award consortium, led by the National Institutes of Health National Center for Advancing Translational Science. Established in 2010, ACTRI provides infrastructure and support for basic, translational and clinical research throughout the San Diego region to bring discoveries from the laboratory to the bedside, and facilitates training and education of the next generation of researchers. ACTRI carries out its activities in collaboration with institutional and corporate partners and currently has more than 1,500 members.