World’s First Clinical Improvement! Sun Yat-sen Memorial Hospital Collaborates with Shize Bio to Advance Universal iPSC-Derived Neural Cell Therapy for Spinal Cord Injury

On July 17, 2025, a landmark achievement was made in the “world’s first” dual-registration clinical trial approved by both Chinese and U.S. regulatory authorities—the “Clinical-Grade iPSC-Derived Subtype-Specific Spinal Neural Progenitor Cells for Spinal Cord Injury Treatment” project. This groundbreaking initiative, jointly advanced by the Third Affiliated Hospital of Sun Yat-sen University, the First Affiliated Hospital of Dalian Medical University, and SiCell Biotechnology, successfully completed the “world’s first” patient dosing. Notably, encouraging therapeutic effects were observed shortly after treatment, marking a milestone in the study.

The recipient, Mr. Wan, a 54-year-old male, suffered fractures and instability in the C4 and C5 vertebrae due to a traffic accident on the evening of June 6. The severe trauma, combined with compression from a displaced bone fragment at the posterior edge of the C4 vertebra, led to spinal cord injury. After emergency treatment at a local hospital—including high-dose methylprednisolone therapy, skull traction, and dehydration management—he was transferred to our department on June 19. At admission, the patient exhibited complete paralysis (Grade 0 muscle strength) below the elbow in both upper limbs, diminished light touch sensation below the C5 dermatome, absent pinprick sensation, and loss of bladder/bowel control. His ASIA score was 82, classified as Grade B.

Preoperative imaging data of the patient

The patient developed pleural effusion and pulmonary infection due to trauma and prolonged bed rest. After targeted treatment, on June 24, 2025, our department successfully performed a 3D microscope-assisted anterior cervical discectomy and fusion (ACDF) with decompression and internal fixation at C4/5. The surgery was led by Professor Rong Limin, the clinical principal investigator of this project and discipline leader of orthopedics at the Third Affiliated Hospital of Sun Yat-sen University, with Dr. Dong Jianwen, Director of Spinal Surgery, serving as the first assistant. The procedure was completed smoothly, and the patient remained in stable condition postoperatively with favorable recovery.

Professor Rong Limin performing the surgery

After the patient’s postoperative condition stabilized, on July 17, Mr./Ms. Wan successfully underwent intrathecal injection of the iPSC-derived regenerative spinal cord neural cell therapy (XS228 Cell Injection) as the world’s first trial participant. Following the infusion, the patient exhibited no adverse reactions, with all monitoring parameters within normal ranges. The observation period was completed uneventfully, and the patient has now entered the formal follow-up phase.

The intrathecal cell injection was performed by Dr. Pang Mao, Associate Chief Physician of Spinal Surgery.

In the days following the infusion, the patient’s motor function showed remarkable improvement! Prior to treatment, due to the right-sided location of spinal cord-compressing fracture fragments, the patient’s right hand and leg had been completely paralyzed (muscle strength grade 0). As of July 29 (12 days post-infusion), the patient’s right lower limb had regained flexion-extension movement, with slight finger flexion possible in the right hand. Most notably, the left lower limb achieved overall muscle strength recovery to grade 4-5 levels!

Motor Function Improvement in All Four Limbs 12 Days After Cell Therapy

Comparative Assessment of Limb Muscle Strength Grading Before and After Cell Therapy

The successful administration and remarkably promising therapeutic outcomes in this first trial subject have significantly boosted the confidence and motivation of all project team members, while further advancing the continued progress of this globally innovative research endeavor embodying Chinese scientific excellence.

Research Team Group Photo of the Project