Implanted device expected to provide an easy and effective treatment for patients with high-risk type 1 diabetes.
ViaCyte recently announced that the first patients have been implanted with the PEC-Direct product, which is an islet cell replacement approach for patients with diabetes who have a high-risk of life-threatening complications, according to a press release.
The goal of the clinical trial is to evaluate the safety and efficacy of the PEC-Direct product candidate. It is currently being conducted at the University of Alberta Hospital in Canada and the UC San Diego School of Medicine’s Altman Clinical Trials Research Institute, but is expected to be conducted at additional locations in the future.
The first group of patients with type 1 diabetes received multiple small cell-filled devices—called sentinels—to evaluate the safety and viability of the implant, according to ViaCyte. The sentinels will be removed and examined to determine the progression of engraftment and maturation in pancreatic islet cells.
ViaCyte expects to start enrolling the second group of 40 patients later this year to evaluate the safety and efficacy of the implant.
The primary efficacy outcome includes the production of insulin—measured by the biomarker C-peptide—in patients whose natural production has been reduced or stopped. Other endpoints include insulin usage and hypoglycemic events.
“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,” said investigator James Shapiro, MD, PhD, FRCSC. “An effective stem cell-derived islet replacement therapy would solve these issues and has the potential to help a greater number of people.”
The PEC-Direct product candidate is being created for patients with type 1 diabetes who have hypoglycemia unawareness, extreme glycemic lability, and severe hypoglycemic episodes, according to the release. These patients are considered to have high-risk type 1 diabetes.
“Patients with high-risk type 1 diabetes complications, such as hypoglycemia unawareness, are at constant risk of life-threatening low blood glucose,” said investigator Jeremy Pettus, MD. “The PEC-Direct islet cell replacement therapy is designed to help patients with the most urgent medical need.”
The PEC-Direct product candidate delivers stem cell-derived pancreatic progenitor cells through a device. After implantation, the cells are expected to become mature islet cells, according to the release.
The implant provides an unlimited supply of cells and can deliver a more consistent and straightforward mode of delivery compared with cadaver islet transplants, according to ViaCyte.
“There are limited treatment options for patients with high-risk type 1 diabetes to manage life-threatening hypoglycemic episodes,” said Paul Laikind, PhD, president and chief executive officer at ViaCyte. “We believe that the PEC-Direct product candidate has the potential to transform the lives of these patients and we are excited to move closer to that goal with the initiation of clinical evaluation announced today. This also represents a step towards a broader application of the technology. We remain fully committed to developing a functional cure for all patients with insulin-requiring diabetes. To that end, we are hard at work on next-generation approaches as well, and expect the work with PEC-Direct to further advance our knowledge and drive progress.”