Treatment begins in trial of islet cell replacement therapy
The first participants have been treated with a novel islet replacement therapy in a new clinical trial, according to a press release from ViaCyte.
The islet replacement cell therapy (PEC-Direct, VitaCyte) delivers stem-cell derived pancreatic progenitor cells in a device. The cells then have the potential to become mature human islet tissue, from which beta cells can arise.
In the first study cohort, participants with type 1 diabetes will receive multiple small-format cell-filled devices, called sentinels, which will then be removed at specific time points and examined to provide insights into the islet cells.
“Islet transplants have been used to successfully treat patients with unstable, high-risk type 1 diabetes, but the procedure has limitations, including a very limited supply of donor organs and challenges in obtaining reliable and consistent islet preparations,” James Shapiro, MD, PhD, FRCSC, director of the clinical islet transplant program at the University of Alberta, said in the release. “An effective stem cell-derived islet replacement therapy would solve these issues and has the potential to help a greater number of people.”
The researchers aim to enroll a second cohort of up to 40 participants by the end of the year for a safety and efficacy study, according to the release.
Efficacy will be evaluated through C-peptide measurements, which represent clinically relevant production of insulin. The researchers will also be looking at injectable insulin usage and incidence of hypoglycemia.
The study is being funded in part by JDRF.