US-based regenerative medicine firm ViaCyte has obtained approval for its investigational new drug (IND) application from both the US Food and Drug Administration and Health Canada to initiate a clinical trial for investigating PEC-Direct in patients suffering from type 1 diabetes.
PEC-Direct is being developed as a potential islet cell replacement therapy candidate.
It provides PEC-01 stem cell-derived pancreatic progenitor cells in a device to facilitate direct vascularisation.
The open-label, international trial will assess the safety and efficacy of PEC-Direct in 40 subjects across several clinical sites such as the University of Alberta in Edmonton, the University of Minnesota and UC San Diego.
ViaCyte president and chief executive officer Paul Laikind said: "ViaCyte was the first to differentiate human stem cells into glucose-responsive, insulin-producing cells, and now we are running the first and only clinical trials of stem cell-derived islet replacement therapies for type 1 diabetes.
"Type 1 diabetes patients continue to deal with the daily impact of the disease and remain at risk for often severe long-term complications.
“This is especially true for the patients with high-risk type 1 diabetes, who face challenges such as hypoglycemia unawareness and life-threatening severe hypoglycemic episodes.”
The trial will recruit high-risk patients for acute life-threatening complications.
While clinically relevant insulin production will be measured as primary endpoint through the C-peptide insulin biomarker, the use of injectable insulin and hypoglycemic event incidence will also be evaluated during treatment.