A new treatment for Type 1 diabetes shows positive results in its first clinical trial and could be available to the public in three to four years, according to researchers.
The treatment consists of a cell pouch that is implanted deep beneath the skin and is then transplanted with islet cells. The new technology aims to simplify everyday treatment for diabetics by reducing or eliminating the need for insulin injections, according to Philip Toleikis, the president and CEO of the regenerative medicine company Sernova which created the pouch.
The current trials at the University of Chicago include seven patients, but the positive results currently being reported come from the trial’s first patient’s results. One hundred more patients have expressed interest in the trials but will need to go through the screening process in order to proceed, Toleikis said.
The results from the first patient’s 90-day trial show that the pouch technology is safe and successful at stabilizing blood sugar levels.
“This is groundbreaking research in this field,” Toleikis said. “It’s highly disruptive, and we’re trying to change the therapy for diabetic patients.”
The current treatment for Type 1 diabetics requires that a patient measure blood sugar levels and take insulin injections about four to six times a day or wear an insulin pump, Toleikis said.
However, because the trial has shown that the transplanted islet cells are able to produce insulin on their own, patients with pouches will face a lower risk of hypoglycemic events — when a person’s blood sugar falls below the normal level — potentially increasing their chance of survival.
Without the correct technology to monitor blood sugar, patients with the most severe cases of Type 1 diabetes, what’s called hypoglycemia unawareness, are essentially “playing Russian roulette” with every insulin injection they take, Toleikis said. Patients with hypoglycemia unawareness are not aware of steep drops in their blood sugar because they don’t experience the normal symptoms of low blood sugar.
“If we can eliminate that with a dose of islet cells ... it’s a significant improvement in their lifestyle, they don’t have to worry so much,” he said.
The trials measure levels of c-peptide, a marker that insulin is being released, as well as the actual level of insulin in the bloodstream. Researchers found that the islet cells are functioning properly by responding to the blood sugar levels.
“The ultimate goal is to have a stem-cell technology that is glucose responsive that can then treat all patients with Type 1 diabetes,” Toleikis said. “By showing that these cells are surviving, that they’re actually functioning, is a very significant advancement in this field.”
