World’s first spinal cord regrowth trial approved in historic health milestone

A new chapter in medical science is being written as the world’s first regenerative cell therapy for spinal cord injuries (SCI) receives official approval to begin Phase 1 clinical trials. This potentially life-changing advancement could finally provide a solution for a condition that, for decades, has been deemed untreatable.

According to New Atlas, the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) have jointly approved a global trial to test this cutting-edge treatment.

More than 15 million people worldwide live with the effects of SCI, which often result from car accidents, sports injuries, falls, or workplace trauma. Current treatment options remain limited to pain management, surgery, and long-term rehabilitation, with little hope of restoring full function.

The breakthrough comes from Chinese biotech company XellSmart, which has developed an allogeneic induced pluripotent stem cell (iPSC) therapy. Unlike traditional therapies that use a patient’s own cells, this new method utilizes off-the-shelf donor stem cells that can mature into specialized neurons. The treatment is designed to not only repair the damaged spinal tissue but to regenerate the entire neural network—potentially restoring mobility and sensation.

XellSmart emphasized the challenges of nerve regeneration within the central nervous system, stating that “most patients are left with permanent disability, negatively impacting their quality of life.” This new approach offers a ray of hope where conventional methods have fallen short.

One of the major advantages of this therapy is its scalability. Because it uses donor-derived cells rather than patient-specific material, the treatment is immediately available and can be mass-produced. Moreover, advances in identifying ideal cell subtypes have significantly reduced the risk of immune rejection.

Following four years of extensive preclinical research, the Phase 1 human trial will focus on evaluating the treatment’s safety, appropriate dosage levels, and initial effectiveness. If successful, it will move into a larger Phase 2 trial by 2028. Experts believe the therapy could be approved for widespread use within five to seven years—potentially transforming SCI care forever.

For millions living with spinal cord injuries, this new therapy doesn’t just represent hope. It represents the real possibility of reclaiming lost movement, independence, and quality of life.