New islet cell replacement therapy applies for human trials

A new islet cell replacement therapy, with advantages over islet cell transplantatio, has had an application to start human trials submitted to the US Food and Drug Administration (FDA).
The new technology is called ‘beta cell encapsulation therapy’ and serves to replace the insulin producing beta cells of the pancreas that are destroyed by type 1 diabetes. The technology is a result of collaboration between ViaCyte, a pharmaceutical company from San Diego in the USA, and the type 1 diabetes charity, the JDRF.
The most common treatment in type 1 diabetes is to take insulin injections but this can be complicated to manage and can result in dangerously low blood glucose levels (severe hypoglycemia) if errors are made.
A small number of people with type 1diabetes that are at greatly increased risk of severe hypos may apply for islet cell transplantatio, a procedure in which pancreatic beta cells (also known as islet cells) are transplanted into the body. Islet cell transplants can be very effective at improving control and reducing hypoglycemia but they require the transplant recipient to take strong immunosuppressive drugs to prevent type 1 diabetes from attacking the newly transplanted cells. These drugs have disadvantages as they render the immune system less able to fight infection.
The advantage of the new beta cell encapsulation therapy is that insulin producing beta cells are essentially hidde, by a protective coating, from the rogue immune system of type 1 diabetes. Because the insulin producing cells are protected, there is no need for immunosuppressive medications to be taken.
The application that has been sent by ViaCyte and the JDRF is an Investigational New Drug application. If accepted by the FDA, this will allow the new treatment to be tested in patients with type 1 diabetes. Such trials would be phase 1 and phase 2 trials. Three phases of trials need to be successfully passed before the treatment can be considered for authorisation for use in the public.
Jeffrey Brewer, President and CEO of the JDRF in the United States responded to the application, saying: “We are excited to continue our collaboration with ViaCyte and believe beta cell encapsulation therapy may one day virtually eliminate the daily management burden for those living with type 1 diabetes.”