CIRM funded therapy for type 1 diabetes gets FDA approval for clinical trial

diabetes

It’s always nice to start the week off with some good news and we got this week off to a great start with some great news. ViaCyte has been given the green light to start a clinical trial with its therapy for type 1 diabetes, a program we are funding.

ViaCyte applied to the Food and Drug Administration for approval in mid-July, a process that can sometimes take months. They got their approval in a matter of weeks, which, considering the device they are using is so novel and complicated, is a really significant achievement.

As the Chairman of our governing Board, Jonathan Thomas, J.D., Ph.D., noted in a press release we sent out about the news:

“This is a therapy that we have funded from its earliest days so it’s exciting to see that it is now ready to start a First-in-Human trial. Reaching this milestone is a tribute to years of hard work by the team at ViaCyte, but also to the vision of the people of California who created the stem cell agency to support work like this. That vision is one step closer to being realized.”

So what is this new approach that ViaCyte is trying? Well, in type 1 diabetes the pancreas no longer produces the insulin our bodies need to regulate blood sugar levels. That can increase your risk of heart disease, stroke, kidney failure, blindness, even death. ViaCyte has developed a thin plastic pouch, containing an immature form of pancreatic cells, to mimic the blood glucose regulating function of the pancreas. When the device is implanted under the skin these cells are designed to become the insulin-producing and other cells needed to regulate blood glucose levels. It is believed that these cells will be able to sense when blood glucose is high, and then secrete insulin to restore it to a healthy level.

It’s fascinating science but more than that, it’s a really promising program that has the potential to end reliance on daily testing and injections of insulin for people with type 1 diabetes. It could dramatically change their lives.

Of course this is just one step along the way and, encouraging as it is, it is also important to place it in context. This is the first time it’s being tried in people. In all the pre-clinical testing it’s looked promising, but this is the only test that really counts, seeing if it works in patients with type 1 diabetes. Now we get to find out.