New research presented today at the International Society for Stem Cell Research (ISSCR) 2026 Annual Meeting highlights an important step toward developing stem cell-based treatments for chronic spinal cord injury (SCI), for which no effective restorative therapy currently exists.
Hideyuki Okano, MD, Keio University, presented new preclinical efficacy data using clinical-grade gliogenic neural stem/progenitor cells (gNS/PC) for chronic incomplete SCI and new updated plans for an investigator-initiated clinical trial targeting patient recruitment in 2027. This discovery builds on the successful completion of the world’s first first-in-human clinical trial in patients with subacute SCI, which demonstrated a promising safety profile.
The company has already successfully completed the world’s first first-in-human clinical trial in subacute patients, demonstrating a promising safety profile. The transition to the chronic phase is the next logical milestone to build on that solid foundation. As the cellular environment changes over time, we are evolving strategies from simply establishing safety to proactively overcoming the longstanding and stubborn barrier of chronic paralysis. ”
AS Dr. Hideyuki Okano ISSCR Chairman
Future clinical trials will focus on patients with chronic incomplete spinal cord injury who have residual inactive but demyelinated nerve fibers and lack sufficient endogenous cellular support, making them suitable candidates for this remyelination-focused strategy.
“Previous approaches have focused on transplanting ‘neuron-producing’ cells, but chronic injury presents another challenge: residual nerve fibers are present, but the protective insulation has been lost,” Okano said. “Our unique strategy uses gliogenic cells (gNS/PCs) that are specifically tuned to generate the critical supporting cells astrocytes and oligodendrocytes. Rather than trying to grow entirely new nerves, we are essentially ‘repairing and rebooting’ the spinal cord’s existing wiring.”
In preclinical studies, clinical-grade gNS/PCs efficiently differentiated into neurons, astrocytes, and oligodendrocytes in vitro and safely promoted behavioral recovery without forming tumor-like tissue while repopulating the damaged microenvironment after transplantation into chronic injury models.
If confirmed in future clinical studies, this approach could represent a major advance for people living with chronic spinal cord injuries. The physician-led clinical trial is scheduled to begin recruiting patients in 2027, with the long-term goal of developing a safe, standardized treatment that can restore voluntary movement and autonomic function in chronic patients.
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International Stem Cell Research Association
