World’s First Therapy to Reverse Spinal Cord Injury Enters Human Clinical Trial

A major breakthrough in spinal cord injury treatment is on the horizon. For the first time, a regenerative stem cell therapy has been authorized to begin a Phase I clinical trial, with the potential to address a condition that has, until now, had no cure.

Global Regulatory Approval for Clinical Trial

This week, the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) approved a global clinical study aimed at treating spinal cord injury (SCI), a condition that affects over 15 million people worldwide. SCI impacts people of all ages and backgrounds, typically caused by traffic accidents, sports-related injuries, severe falls, and workplace incidents. There is still no definitive cure — current treatments focus on symptom management through surgery and rehabilitation, aiming for some functional recovery. However, most patients are left with permanent paralysis or severe disability.

Chinese biotech company XellSmart is on the verge of changing this scenario. Its allogeneic induced pluripotent stem cell (iPSC) therapy has been given regulatory approval in both the U.S. and China to begin human trials. These pluripotent stem cells are immature cells capable of developing into specific cell types — in this case, neural cells that can replace those damaged or destroyed by spinal injury. The goal is not only to repair the injury but to regenerate the entire damaged region.

The Urgency and Scale of the Problem

A statement from XellSmart noted, “Every year, China and the U.S. report approximately 100,000 and 18,000 new cases of acute or subacute SCI — that’s nearly 10 and 2 new cases every hour, respectively.” The company emphasized that most patients suffer lifelong disabilities, which drastically reduce their quality of life. Given the central nervous system’s limited regenerative capacity, repairing spinal cord damage remains an immense challenge.

This human trial follows four years of preclinical research and aims to offer a widely accessible solution that doesn’t rely on harvesting the patient’s own cells.The researchers propose an “off-the-shelf” therapy that doctors can use for any SCI patient, which makes mass production and distribution more feasible.

Scientists have already gained a strong understanding of cell subtyping, which allows them to use allogeneic cells — derived from donors rather than the patient — with a low risk of rejection.

Researchers are conducting the trial in collaboration with the Third Affiliated Hospital of Sun Yat-sen University in China, a leading institution in spinal injury treatment and research.

Part of a Broader Cell Therapy Portfolio

This study joins XellSmart’s other research efforts, which include cell therapies for Parkinson’s disease and amyotrophic lateral sclerosis (ALS). If the SCI trial proves successful and this novel treatment reaches the market, it could be life-changing for those living with paralysis.

Researchers expect to conclude the Phase I trial — which tests safety, efficacy, and dosage — by next year. If the results prove successful, they plan to begin Phase II around 2028. Within five to seven years, they could mass-produce the therapy and make it commercially available.

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

Read the original article on: New Atlas

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