You are here

$20 million granted for clinical trial of stem cell therapy for high-risk type 1 diabetes



ViaCyte Inc., a privately held regenerative medicine company, has been awarded a $20 million grant from the California Institute for Regenerative Medicine (CIRM) to support the clinical development of its PEC-Direct™ product candidate.  This novel cell replacement therapy is being developed as a functional cure for patients with type 1 diabetes who are at high risk for acute life-threatening complications.

PEC-Direct is currently in a Phase 1/2 open-label clinical trial at multiple sites in the United States and Canada to evaluate safety and efficacy. CIRM previously provided support for the pre-clinical studies that laid the critical groundwork for the present clinical evaluation of the PEC-Direct product.

"With PEC-Direct we intend to address a critical unmet medical need for people who are most severely impacted by type 1 diabetes. These patients are often eligible for islet transplants, a procedure that can be highly effective but suffers from a severe lack of donor material,” said Paul Laikind, Ph.D., president and CEO of ViaCyte. “We believe PEC-Direct could overcome some of the key limitations of islet transplant by providing a virtually unlimited supply of cells manufactured under quality-controlled conditions, a safer and more optimal route of administration, and a reduced cost." 

The PEC-Direct product candidate delivers stem cell-derived PEC-01 pancreatic progenitor cells in a device designed to allow direct vascularization of the cells, which is expected to allow for a robust engraftment and cellular performance similar to the anatomy of a normal islet.  Given the open nature of the device, patients implanted with PEC-Direct, as with other transplants, will require immune suppression.  

Thus, it is being developed to treat patients with the greatest unmet medical need, including type 1 diabetes patients who already require immune suppression following a kidney transplant, as well as type 1 patients who are at high risk for acute complications, such as hypoglycemia unawareness, extreme glycemic lability, and/or severe hypoglycemic episodes. 

It is estimated that about 140,000 people in United States and Canada, or about 10% of type 1 diabetes patients, have high-risk type 1 diabetes.

The clinical trial is under way at the UC San Diego School of Medicine's Altman Clinical Trials Research Institute, the University of Alberta Hospital in Edmonton, Alberta, and the University of Minnesota, with additional sites planned in the U.S. and Canada. 

Learn more: