Local newspaper U-T San Diego covered the news that the FDA accepted ViaCyte’s application to begin clinical trials to evaluate the VC-01™ product candidate. The therapy will be tested for safety and efficacy in patients with type 1 diabetes who have minimal to no insulin-producing beta cell function.
VC-01 is the combination of PEC-01™, pancreatic endoderm cells that are designed to further differentiate and mature into the full complement of pancreatic islet cells upon implant, and the Encaptra® drug delivery system, a semi-permeable pouch that lets nutrients in and insulin and other factors out, but is expected to protect the cells from the immune system.
The article also credits the California Institute for Regenerative Medicine (CIRM) for investing more than $38 million in the development of VC-01. CIRM was created in November 2004 by California voters. In passing the ballot initiative known as Proposition 71, California allocated $3 billion in state bond money to stem cell research and the development of new stem cell-based therapies.