Good news! Approved for trial simultaneously by the US and China!
"... A paradigm shift in the way we treat spinal injuries is now in sight, with the world's first regenerative cell therapy being granted approval for a registrational Phase I clinical trial. ...
This week, the US Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) approved the global clinical trial to treat spinal cord injury (SCI), which is estimated to affect more than 15 million people worldwide. ...
Now, Chinese biotechnology company XellSmart has the potential to change this forever, as its allogeneic induced pluripotent stem cells (iPSC) regenerative therapy has been given the green light by both US and Chinese health administrations to enter a clinical trial. ... The treatment aims to not just repair the injury but provide the foundation to regrow all the cells needed to return function to the damaged region. ...
The SCI trial is being conducted in partnership with Sun Yat-sen University's Third Affiliated Hospital in China, a specialist in treating and researching these complex spinal injuries. ..."
Apparently, China has a several years long history of approving such or similar therapies, possibly well ahead of Western countries:
"... In 2023, China's first iPSC-derived cell therapy (XS228 injection), developed by XellSmart, received FDA approval and was granted global orphan drug designation (ODD).
In 2024, China's first national-level registered clinical study of iPSC-derived cell therapy for neurological diseases was approved to treat Parkinson's disease patients—including China's first case. More than 12 months of follow-up demonstrated good safety and significant improvements in "off" time, MDS-UPDRS scores, and multiple non-motor symptoms.
In 2024, the world's first national-level registered clinical study of iPSC-derived cells (XS228 injection) for amyotrophic lateral sclerosis (ALS) was approved. Multiple ALS patients including the world's first case were treated safely, with preliminary data showing effective slowing of disease progression.
In 2025, China's first allogeneic off-the-shelf iPSC-derived dopaminergic neural progenitor cell (XS411 injection) registrational Phase I clinical trial was launched, led by the National Neurological Disease Medical Center at Beijing Tiantan Hospital, targeting Parkinson's disease — the world's second most common neurodegenerative disorder.
In 2025, China's first randomized, double-blind controlled registrational Phase I/II clinical trial was launched, led by Huashan Hospital affiliated with Fudan University (also a National Neurological Disease Medical Center), targeting early-onset Parkinson's disease (EOPD).
In 2025, the world's first registrational Phase I/II clinical trial of an allogeneic off-the-shelf iPSC-derived subtype-specific neural progenitor cell therapy (XS228 injection) was launched by Peking University Third Hospital, targeting amyotrophic lateral sclerosis (ALS), one of the world's four major incurable diseases. ..."
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