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World’s First Stem Cell Trial for Spinal Cord Injury Carried Out in Japan
Researchers at Japan’s Keio University have carried out a stem cell treatment in a patient with a spinal cord injury. The recipient of the trial will remain under observation for three months to determine the safety of the method.
Regenerative Powers of iPS Cells
The first-of-its-kind trial involved the use of induced pluripotent stem cells (iPS) that were implanted into the patient’s spinal cord. iPS cells are created by stimulating mature cells from the body into stem cells in vitro. The technology to create these cells was pioneered by Japanese researcher Shinya Yamanaka and his team in 2006 by inducing mature cells with genes of four transcription factors, now called Yamanaka factors. Once back to their stem cell state, these cells can be differentiated into any cell type by providing them with the necessary growth conditions.
Researchers at Keio University wanted to determine if iPS could be used to treat spinal cord injuries. They had received necessary regulatory approvals for the trial in 2019 but the ongoing pandemic delayed the trial.
The team also needed the recipient to have had the spinal cord injury in less than 28 days prior to the intervention. Although details of the recipient have not been revealed, the press release confirmed that more than two million iPS cells were injected into the patient. The number of cells to be injected was determined after safety experiments in animal models.
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Safety of Stem Cell Therapy
Professor Masaya Nakamura who led the research team at Keio University called the intervention “a huge step forward,” but also added that “lots of work (remained) to be done” before it could be used as a treatment.
At this stage of the study, the researchers majorly want to know if the intervention is safe to be performed. An independent committee will observe the patients for a period of three months to determine the same, after which the method could be used on other patients.
Although the observations will include the therapeutic benefits of the transplant to see if neurologic function and hence the quality of life can be improved with this intervention, the researchers stressed that determining safety was their top priority at the moment.
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