To mark the occasion of a new stem-cell therapy to treat spinal cord injuries becoming available in Japan, a special meeting of the Japan Association for Mesenchymal Stem Cell Therapy was held in Sapporo, Japan, on 25 May 2019.
Developed by Osamu Honmou of Sapporo Medical University in Hokkaido, and his team, the therapy involves taking stem cells from a patient’s bone marrow, cultivating them outside the body, and then intravenously injecting them back into the patient.
This treatment could improve the lives of many people — the World Health Organization estimates that globally between 250,000 and 500,000 people suffer a spinal cord injury each year. Physiotherapy rehabilitation is currently the only treatment avenue for patients with spinal cord injuries, but it is often terribly slow and results in limited improvement. If effective, the new treatment could improve the lives of many people as well as ease the national social and financial cost of spinal cord injury.
Honmou’s stem-cell therapy underwent a clinical trial last year, and of the 13 participants, 12 improved one level or more on the five-level American Spinal Injury Association’s Impairment Scale for assessing spinal cord injuries, Honmou explained at the meeting. He also showed a video of the recovery of one of the patients, who went from being confined to bed to being able to walk unaided. The video had been shown a few weeks earlier on national television as part of a documentary by NHK, Japan’s national broadcaster, on Honmou’s treatment.
The treatment will continue to be assessed over the next seven years as it is offered to those sustaining injuries. If it is shown to be effective at the end of that period, it will receive final approval from the Pharmaceuticals and Medical Devices Agency, enabling it to be marketed.
After Honmou’s presentation, two other talks set the therapy within the context of two ambitious programs. Soichiro Isobe, director of the Compliance and Narcotics Division of the Ministry of Health, Labour and Welfare, spoke about the Japan government’s Sakigake program. The program seeks to fast-track the adoption of promising therapies and bring them to patients as quickly as possible. The spinal cord therapy was approved for incorporation in this program in 2016. As a result, patients can receive the therapy now, which might otherwise have taken several more years to become available. Honmou’s treatment is one of eight therapies that have been accepted for the program to date.
Next, Masanori Fukushima, director of the Translational Research Center for Medical Innovation (TRI), described how the center is supporting for a range of regenerative medicine projects. Fukushima explained that Honmou’s therapy was selected as a top priority in 2007 because he recognized that it was a world first.
Honmou and his team now intend to find out more about the mechanisms behind the therapy. “We anticipate that we may need to revise our concepts,” Honmou said. Fukushima explained: “This could involve new neurology, and we might need to rewrite the textbooks.”