Photo/Illutration Doctors from Kyoto University Hospital attend a news conference in Kyoto’s Sakyo Ward on Sept. 2. (Rintaro Sakurai)

KYOTO--Kyoto University Hospital next February will start a clinical trial to develop an easier treatment for intractable type 1 diabetes by using cellular sheets derived from induced pluripotent stem (iPS) cells.

The medical center said on Sept. 2 that the pancreatic islet cell sheets will be transplanted to severe diabetes patients in the planned phase I trial.

If these sheets work effectively, the technology could spare diabetes patients from the troublesome task of taking daily insulin injections.

The team includes scientists from Kyoto University’s Center for iPS Cell Research and Application (CiRA).

Type 1 diabetes is caused by immune abnormalities and other problems that destroy pancreatic islet cells, leading to a significant reduction in insulin production.

It is difficult for type 1 diabetics to recover through healthy diets and exercise alone, unlike type 2 diabetics, who can often alleviate their symptoms with such lifestyle changes.

The mainstay therapy for type 1 diabetes is for patients to administer insulin injections several times daily to lower blood glucose values. This treatment places a heavy burden on patients.

An estimated 100,000 to 140,000 people in Japan have type 1 diabetes.

The research team plans to put its transplantation method into practical use in the 2030s after its safety and effectiveness are confirmed.

“The technology is expected to help lessen the possibility of blood glucose fluctuations, diminishing the risk of patients being taken to medical centers in emergencies,” Daisuke Yabe, a professor of studies on diabetes, internal secretion and nutritional internal medicine at Kyoto University Hospital, said at a news conference on Sept. 2.

Yabe continued, “I would be very happy if the futuristic world comes into sight where people no longer need any insulin injections, though we have still a long way to go.”

Among the options currently available is transplanting islet cells from deceased donors. But only a few such cases are reported annually across Japan.

The scientists from CiRA instead completed the technology to turn pancreatic islet cells created from iPS cells into sheet form.

Under the plan, pancreatic islet cells will be engineered from iPS cells of healthy people and converted into sheets, each measuring several centimeters by several centimeters.

Multiple sheets can be subcutaneously transplanted into patients’ abdomens.

Three patients between the ages of 20 and 64 with serious type 1 diabetes will be subject to the trial. The method’s safety will be monitored over a year in the phase I trial.

An earlier experiment verified the technology’s effectiveness among mice, the team said.

Kyoto University Hospital drew up a clinical trial plan, which was approved within the school on Aug. 23.

The medical center applied to the government-affiliated Pharmaceuticals and Medical Devices Agency (PMDA) on Sept. 2.

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