Type 1 diabetes: iPS cell-based clinical trial surgery successful
– Diabetic patient’s progress is good, discharged safely
– Safety to be verified after 5-year follow-up
Summary from the Yomiuri Shimbun article.
Kyoto University Professor Daisuke Yabe: Sakyo Ward, Kyoto City:
On April 14, he announced the first case of treatment in Japan.
1. Surgery to treat severe type 1 diabetes was performed using iPS cells.
2. The patient’s progress is good, and he has already been discharged from the hospital.
What is type 1 diabetes:
1. Type 1 diabetes is most prevalent in people aged 10-15, with an estimated 100,000-140,000 patients in Japan.
2. Usually requires several insulin injections every day.
If severely ill patients cannot control their blood sugar levels well, they may develop hypoglycemia, lose consciousness, and even die.
This iPS cell trial surgery:
The subjects of the trial are three seriously ill patients aged 20-64.
1. From iPS cells from healthy individuals, islet cells that release insulin in the pancreas are created.
2. The cells are processed into sheets of several centimeters square, and several sheets are transplanted into the patient’s lower abdomen.
After surgery, the patient will be observed for five years to verify safety and effectiveness.
First surgery:
In February of this year, iPS cells were transplanted into a woman in her 40s at Kyoto University Hospital.
1. It was confirmed that insulin was being released from the transplanted cells.
2. There were no safety issues, such as abnormal cell proliferation.
3. The woman has continued to self-inject since being discharged from the hospital.
Kyoto University Hospital will check the engraftment of the transplanted cells and the insulin secretion status.
Details of the next iPS cell surgery:
1. The number of transplanted cells will be gradually increased in the next two and three surgeries.
2. An interim report on the safety of the second and third cases will be made next year.
After that, “a Kyoto University startup that manufactures the sheets” will conduct international joint clinical trials in Europe and the United States.
Professor Yabe said about this treatment, “We aim to put it to practical use after 2030.”
Number of type 1 diabetes patients:
1. There are an estimated 8 million type 1 diabetes patients worldwide.
2. Type 1 accounts for 5% of diabetes cases, and differs from type 2, which is largely influenced by lifestyle.
In type 1, the islet cells in the pancreas are destroyed by the patient’s own immune cells.
In addition, insulin, which lowers blood sugar levels, is hardly secreted at all.
iPS cells contribute to diabetes treatment:
Concerns of type 1 diabetes patients:
1. Many children suffer from type 1 diabetes and endure daily insulin injections.
2. If the new treatment eliminates the need for injections, it will be possible to avoid life-threatening hypoglycemia.
Type 2 diabetes patients’ concerns:
Currently, pancreatic islets from deceased donors are transplanted, but there are not many donors.
1. In the future, this will also be applicable to patients with severe type 2 diabetes, which is common among middle-aged and elderly people.
2. There are 10 million type 2 patients in Japan, including those at risk.
Future challenge: mass production of iPS cells
1. The number of iPS cells transplanted this time is estimated to be more than tens of millions.
2. This is a significantly larger number than other disease treatments using iPS cells.
The first patient has only been transplanted for about two months, and will need to be carefully monitored for a long period of time.
“Orizuru Therapeutics” (Kanagawa Prefecture):
“Orizuru Therapeutics” is in charge of manufacturing the sheets and is working on regenerative medicine using iPS cells.
The company has taken over the technology that Kyoto University and Takeda Pharmaceutical Co., Ltd. have jointly researched.
https://www.yomiuri.co.jp/science/20250414-OYT1T50145/2/