ViaCyte encapsulated islet cells show survival success in type 1 diabetes trial

Benedict Jephcote
Tue, 26 Jun 2018
ViaCyte encapsulated islet cells show survival success in type 1 diabetes trial
ViaCyte's encapsulated islet cell technology for type 1 diabetes has shown positive survival rates after two years in humans.

The PEC-Encap product, also known as VC-01, is a pioneering stem cell therapy that involves a pouch which encapsulates lab-grown human islet cells. It has been designed to replicate how a healthy pancreas works in someone who does not have diabetes and work as a 'functional cure' for people with type 1 diabetes.

The PEC-Encap product is implanted under the skin during a simple outpatient surgical procedure. The cells that are passed into the body have been designed to mature into pancreatic cells that secrete insulin and regulate blood sugar levels.

In the STEP ONE clinical trial, the researchers were pleased to observe that when successful engraftment happened, the implanted cells survived and matured into cells capable of producing hormones including insulin and glucagon. Furthermore, these cells survived for long durations and were able to proliferate.

For the engraftment to be successful, the body needs to grow blood vessels to feed the pouch of islet cells. The downside is that successful engraftment occurred at a low level. However, the fact that success was observed offers hope that the process can be refined and improved upon.

In addition to showing survival success, the treatment was shown to be safe and well tolerated by participants.

Dr Howard Foyt, the company's vice president and clinical development and chief medical officer, said, "The preliminary results from the STEP ONE clinical trial suggest that we are on the right track. In addition to being safe and well-tolerated thus far, the results indicate that when successful engraftment occurs, the implanted cells survive, proliferate, and mature to cells capable of producing insulin and other regulatory hormones.

"The study has also shown that the Encaptra Cell Delivery System protects the cells from rejection by the patient's immune system."

Clinical investigator Professor Robert Henry, from the University of California San Diego School of Medicine, said: "To see the pancreatic progenitor cells survive and mature into endocrine cells in patients further supports the promise of this approach as a potentially transformative treatment for patients with type 1 diabetes.

ViaCyte was granted permission to start testing the therapy in human clinical trials in 2014 after animal research had showed the treatment had consistently shown to be effective.

The study shows that significant success has been made but more research and development will be required to work on increasing successful engraftment.

The findings have been presented at the American Diabetes Association's (ADA) 78th Scientific Sessions in Orlando.
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