Twenty years have passed since mouse iPS cells were first announced in 2006. On February 19, 2026, Japan's Ministry of Health, Labour and Welfare convened its Pharmaceutical Affairs Council (Committee on Regenerative Medical Products and Biotechnology), which endorsed two regenerative medical products derived from iPS cells for conditional, time‑limited approval for manufacturing and marketing.

With decades of basic research and physician‑led clinical trials now behind us, iPS cell technology is finally progressing from the research stage toward real-world use in clinical practice. This endorsement represents a crucial milestone in establishing regenerative medicine as a standard medical practice in Japan. Under this approval framework, the next phase will involve carefully administering the product in medical settings for thorough evaluations of its long‑term safety and effectiveness.

Important Notice
At this point, the products have only been endorsed by the advisory committee and await formal approval. Treatments are not yet available, and applications are not being accepted at present. To avoid interfering with regular medical services, we kindly ask that you refrain from contacting hospitals with inquiries at this time.
(Note: The following comments were shared on February 19, 2026 )

Comments from Director & Professor Jun Takahashi
"Today, media reports announced that an iPS cell-based product for Parkinson's disease has been endorsed for conditional and time‑limited approval by the Ministry's advisory committee.

I would first like to express my sincere gratitude to the patients who participated in our clinical trial and to everyone who has supported this research over the years.

This decision marks a major step forward, but we are still awaiting the official approval notice. And even when that comes, it will not mark the end—only the beginning of a new stage in medical practice. Conditional and time‑limited approval means we must continue to confirm the product's safety and effectiveness through careful administration in actual clinical settings.

We will begin slowly, with a limited number of cases, as it will be essential to accumulate long‑term data. At this time, it does not mean that the treatment is immediately available to all patients. Following formal approval, information on the facilities performing cell transplantations and the eligibility criteria will be available. For now, we ask everyone to avoid contacting medical institutions directly, as this may disrupt regular medical care.

Pharmaceutical companies will ultimately lead full-scale product distribution and stable supply. From our side, we will continue to provide scientific and technical support so that this therapy can become a reliable, widely accessible option as soon as possible."


Comments from Director Emeritus & Professor Shinya Yamanaka
"Today's reports indicate that a regenerative medical product using iPS cells has received endorsement for approval by the Ministry's advisory committee.

Reaching this milestone exactly twenty years after the first announcement of mouse iPS cells is deeply meaningful, and I am delighted to see such progress toward real-world application.

At the same time, establishing this as a medical treatment will require examining safety and effectiveness in many more clinical cases. It is vital that we proceed carefully and steadily, without losing our scientific discipline. I sincerely appreciate everyone's continued understanding and support as we take these next steps forward."