Third Affiliated Hospital of Sun Yat-sen University Leads Launch of World's First iPSC-Derived Neural Cell Clinical Trial for Spinal Cord Injury

Background

Spinal cord injury is a serious medical condition that frequently leads to long-term disability due to limited natural regeneration of neural tissue. According to announcements from the hospital associated with the trial, the condition affects approximately 15 million people worldwide, with about 4 million cases in China. Standard treatments typically involve surgical stabilization to prevent further damage, medications, and intensive rehabilitation, but options for meaningful neural repair have remained limited.

What was achieved

The Third Affiliated Hospital of Sun Yat-sen University served as the lead institution for the launch of what sources describe as the world's first Phase I/II registered clinical trial of an allogeneic universal iPSC-derived subtype-specific neural precursor cell therapy for spinal cord injury. The trial, sponsored by Shize Bio (XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.) with the product known as XS228 Cell Injection, held simultaneous startup meetings in Guangzhou and Dalian on or around July 2, 2025. It received approvals from both China's National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) in May 2025 without requests for additional information.

Professor Rong Limin, president of the hospital and an expert in orthopedics and spinal surgery, acted as the clinical principal investigator. The first participant received intrathecal dosing of the cells on July 17, 2025, following initial surgical decompression and stabilization. The collaborating site was the First Affiliated Hospital of Dalian Medical University under Professor Liu Jing. Updates from hospital sources reported that the initial infusion was completed without immediate serious adverse events, with the patient entering follow-up observation.

How it works

Induced pluripotent stem cells (iPSCs) are generated by reprogramming adult somatic cells to a pluripotent state similar to embryonic stem cells. These iPSCs are then directed in a laboratory setting, under good manufacturing practice conditions, to differentiate into neural precursor cells specialized for the spinal cord environment, referred to as subtype-specific or motor neuron progenitor-like cells. The resulting product is an allogeneic, universal 'off-the-shelf' cell therapy not derived from the individual patient.

In the trial, after patient stabilization, the prepared cells are administered through intrathecal injection directly into the cerebrospinal fluid surrounding the spinal cord. This delivery method allows the cells to potentially reach the site of injury. Preclinical rationale for the approach, as referenced in associated protocol descriptions, includes the cells' ability to integrate, provide trophic support, modulate the injury environment, and promote aspects of neural repair such as remyelination or axonal support. The trial evaluates safety and preliminary signals of effect in subacute cases.

What it means for international patients

The hospital maintains an International Medical Center offering VIP wards, translation services supporting multiple languages including English, and related support for overseas patients. International individuals with spinal cord injury interested in regenerative medicine or clinical research may find such specialized centers relevant when exploring options in China.

Participation in this specific clinical trial is governed by defined inclusion and exclusion criteria, including factors such as age range (reported as 18-65 years), timing since injury (subacute phase), injury severity, and overall health status. Availability and eligibility are not guaranteed and must be confirmed directly with the hospital, as trial recruitment follows regulatory protocols and medical screening.

About the hospital

The Third Affiliated Hospital of Sun Yat-sen University is a Grade III-A comprehensive tertiary public hospital located in Guangzhou, Guangdong Province. Founded in 1971, it is directly affiliated with Sun Yat-sen University and operates multiple campuses with a development model described as 'One Body, Two Wings, Three Cities, Four Hospitals.' It features national key disciplines including in neurology and has established a Spinal Cord Injury Treatment Center.

The hospital has conducted prior clinical research on stem cell therapies for spinal cord injury, including studies using umbilical cord mesenchymal stem cells. It is engaged in international cooperation, including development of international patient services. Professor Rong Limin serves as hospital president and leads efforts in orthopedics and spinal surgery.