Harvard Stem Cell Researchers Cure Type 1 Diabetes In Mice: Next Step FDA Approval For Humans?

Harvard scientists have announced what may be the biggest breakthrough in Type 1 diabetes in since synthetic insulin was created in the 1970s — they have figured out the steps to turn human stem cells into beta cells that will secrete insulin.

Unlike the more common Type 2 diabetes, which is explained in this Inquisitr article, Type 1 — also known as juvenile diabetes — cannot be controlled with lifestyle changes or oral medications. It is a disease in which the body’s own immune system attacks the sugar-sensing, insulin-secreting cells of the pancreas, destroying them. According to NPR, Type 1 diabetics must check their blood sugar levels and inject insulin several times a day, either with needles or an insulin pump, and currently there is no cure for the disease.

Co-director of the Harvard Stem Cell Institute and co-chair of the Harvard Department of Stem Cell and Regenerative Biology, Professor Douglas Melton, was a member of the team of scientists that made the breakthrough discovery after 15 years of research.

“[Injected insulin] is a kind of life-support for diabetics. It doesn’t cure the disease and leads to devastating and very costly complications … such as heart failure and peripheral neuropathy, and other unpleasant consequences of patients not being able to accurately control their blood sugars or their metabolism,” Melton told Harvard Magazine.

“We wanted to replace insulin injections,” he said.

Melton and his colleagues reported in the journal Cell today that they have succeeded in developing a procedure for making millions of pancreatic beta cells in vitro.

He explains that these cells “read the amount of sugar in the blood, and then secrete just the right amount insulin in a way that is so exquisitely accurate that I don’t believe it will ever be reproduced by people injecting insulin or by a pump injecting that insulin.”

The researchers tested the cells on diabetic mice and found that they cured the mice in fewer than 10 days.

“We are very excited about this,” Melton said. “It provides for Type 1 diabetics, in my view, half of the solution to their problem.”

The “half’ he referred to is that sufferers of the disease that lack beta cells. The other half is the fact that their immune system attacks and kills this type of cells.

“So problem one is replacing [beta cells], and these cells are suitable for that kind of replacement,” he said, adding that this would have to be done in combination with some type of immune protections to prevent the body from attacking them.

So how soon can this method be used to cure Type 1 diabetes in humans?

Melton told reporters, “We now know we can make these cells. We have to transfer the protocol to what is called GMP, good manufacturing practice, so that it can be compliant with the very reasonable FDA regulations. So the protocol has to be done with highly purified factors. That is likely to take us about a year. And then …we have to choose the method for Type 1 diabetes that will allow us to put the cells in the patients and protect them from an immune attack.”

Immunosuppressants such as to those used in organ transplants could be one way to prevent the body from attacking the cells, but Melton prefers an encapsulation device developed by an MIT cancer research lab, which would coat and protect the clusters of beta cells, or islets.

Jose Oberholtzer, Director of the Islet and Pancreas Transplant Program and Chief of the Division of Transplantation at the University of Illinois at Chicago commented on the discovery.

“[The work] will leave a dent in the history of diabetes. Doug Melton has put in a lifetime of hard work in finding a way of generating human islet cells in vitro. He made it. This is a phenomenal accomplishment.”

[Image via Diabetes Group]