In a global first, Chinese company XellSmart has received approval to proceed with the first phase of clinical trials for a new spinal cord injury (SCI) treatment using regenerative cell therapy.

The biotechnology firm recently got the green light from the United States’ (US) Food and Drug Administration and China’s National Medical Products Administration to develop a solution that could help an estimated 15 million people who suffer from some form of SCI.

The therapy leverages allogeneic induced pluripotent stem cells (iPSCs) – cells capable of growing into specific cell types – to regenerate neural tissue, aiming to reverse damage often resulting from traffic and sports accidents, various forms of trauma and workplace-related injuries. Current treatments focus on rehabilitation and symptom management, offering little hope of recovery.

XellSmart’s off-the-shelf iPSC therapy, which removes the need for patient-derived cells, promises scalable, low-rejection-risk solutions for broad application. The trial, led by the Third Affiliated Hospital of Sun Yat-sen University, follows four years of preclinical research.

Each year, China and the US report nearly 100 000 and 18 000 new SCI cases respectively. If successful, the therapy could enter wider clinical use before 2032, transforming how spinal injuries are treated.

This trial is the latest in XellSmart’s expanding portfolio addressing major neurological diseases, including Parkinson’s and amyotrophic lateral sclerosis.

A spokesperson recently said: “We’re moving beyond care and into cure. For the first time, we’re offering real hope to millions living with spinal cord injury.”