Kyoto University Hospital is set to begin a clinical trial in February aimed at developing a less burdensome treatment for intractable type 1 diabetes using cellular sheets derived from induced pluripotent stem (iPS) cells. This innovative approach, announced during a press conference on September 2, will involve the transplantation of pancreatic islet cell sheets into patients with severe diabetes as part of a phase I trial.
If successful, this treatment could relieve patients from the daily challenge of insulin injections. The research team comprises experts from Kyoto University’s Center for iPS Cell Research and Application (CiRA).
Type 1 diabetes results from immune system abnormalities that destroy pancreatic islet cells, significantly reducing insulin production. Unlike type 2 diabetes, which can often be managed through dietary and lifestyle changes, type 1 diabetes typically requires multiple daily insulin injections to regulate blood glucose levels, placing a considerable burden on those affected. In Japan, it is estimated that between 100,000 and 140,000 people live with type 1 diabetes.
The research team envisions bringing their transplantation method to practical use in the 2030s, pending the confirmation of its safety and effectiveness. Daisuke Yabe, a professor of diabetes studies at Kyoto University Hospital, expressed optimism about the potential benefits of the technology, stating, “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.” He added, “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.”
Currently, one option for treatment involves transplanting islet cells from deceased donors, but such cases are rare in Japan. The CiRA team has developed a method to create pancreatic islet cells from iPS cells, which are then transformed into sheets several centimeters in size. These sheets can be subcutaneously implanted into the abdomen of patients.
The trial will involve three patients aged 20 to 64 with severe type 1 diabetes, monitoring the safety of the method over the course of a year. Previous experiments indicated its effectiveness in mice. The clinical trial plan was approved by the university on August 23, and an application was submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) on September 2.
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