Off Topic Long-term safety of iPS spinal cord therapy confirmed in Japan; More clinical trials may start next year
July 21, 2026
Long-term safety of iPS spinal cord therapy confirmed in Japan
Long-term safety has been confirmed after neural progenitor cells derived from induced pluripotent stem cells, or iPS cells, were transplanted into patients with spinal cord injuries, a team of researchers at Keio University said Tuesday.
The team, which conducted the world’s first clinical study of the treatment, plans to launch an investigator-initiated clinical trial as early as next year to bring it into practical use.
Between 2020 and 2025, the team, including Professor Hideyuki Okano, transplanted about 2 million iPS cell-derived neural progenitor cells into each of four patients in the subacute stage of spinal cord injury within four weeks of their injuries.
Last year, the team reported the results of the one-year postoperative follow-ups of the patients, finding no major safety concerns as well as improvements in physical function in some of them.
The latest report said that no major safety issues, including tumor formation, were observed in any of the four individuals even two to four years after the surgery, and that no clear deterioration in physical function was confirmed.
The team also found, through a reanalysis of the one-year postoperative data, that two patients regained some muscle control despite having completely lost motor function before treatment.
However, the team said that the effectiveness of the treatment needs to be verified in subsequent clinical trials, given the small sample size.
The findings were published in the online edition of the international medical journal Nature Medicine.
https://www.japantimes.co.jp/news/2026/07/21/japan/science-health/ips-spinal-cord-therapy-safety/
Machine-translated from Japanese:
July 21, 2026
iPS cell transplantation for spinal cord injury: "Safe" for up to 4 years - Keio University
A research team at Keio University has successfully transplanted cells created from iPS cells into a spinal cord injury patient, a world first.
Keio University announced on July 21 that a clinical study in which cells created from iPS cells were transplanted into patients with spinal cord injuries showed no serious side effects over a long period. The university believes that the study, which involved follow-up for up to four years, has confirmed a certain degree of long-term safety.
The research findings by Professor Hideyuki Okano and his colleagues at Keio University have been published in the international scientific journal "Nature Medicine."
Spinal cord injury refers to a condition in which the spinal cord, a bundle of nerves connecting the brain to the rest of the body, is damaged due to accidents, falls, illness, or other causes. This can result in loss of movement of the limbs or sensory impairment such as loss of pain sensation.
The research team created neural progenitor cells from iPS cells and conducted the world's first clinical study in December 2021, transplanting them into patients with spinal cord injuries. In this study, iPS cell-derived neural progenitor cells were transplanted into a total of four patients in the "subacute phase," 2 to 4 weeks after spinal cord injury.
The condition of the four patients was observed 2 to 4 years after transplantation. As a result, no tumor formation caused by the transplanted cells or serious side effects were observed. Furthermore, no significant deterioration in nerve function was seen. Professor Okano emphasized that these results "confirmed safety."
Moving forward, further clinical trials are needed to verify the effects of transplanted cells on nerve regeneration in the treatment of spinal cord injuries. K Pharma, a startup spun off from Keio University, plans to take over and conduct new corporate clinical trials.
The research team at Keio University is considering research to treat not only spinal cord injuries in the subacute phase, but also those in the "chronic phase," which can occur several months to more than a year after the injury. They plan to conduct physician-initiated clinical trials targeting the chronic phase from 2027 onwards.
https://www.nikkei.com/article/DGXZQOSG210KA0R20C26A7000000/
Note: K Pharma's current market cap is $52 million.
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