Caladrius collaborates with Sanford Research on type 1 diabetes

US cell therapy specialist Caladrius Biosciences (Nasdaq: CLBS) has entered into a collaboration agreement with Sanford Research to develop the company’s T regulatory cell therapy product candidate, CLBS03, for the treatment of adolescents with recent-onset type 1 diabetes (T1D).

The initial focus of the collaboration will be the execution of a prospective, randomized, placebo-controlled, double-blind clinical trial to evaluate the safety and efficacy of CLBS03 in adolescents. The Phase II study (The Sanford Project Trutina Study) has an open and active Investigational New Drug (IND) in place and subject enrollment is expected to commence as early as the first quarter of 2016.

Sanford Research, a non-profit research organization that is part of Sanford Health and supports an emerging translational research center focused on finding a cure for T1D, called The Sanford Project, will provide and cover the costs of two initial clinical performance sites. Sanford will enroll study subjects for the trial across its nine-state footprint. Sanford will support the trial by providing funding as well as operational resources to execute subject recruitment, enrollment, treatment and monitoring along with corresponding support services. PCT will provide CLBS03 for the study.