XellSmart Doses World’s First Patient in Spinal Cord Injury Cell Therapy Trial

XellSmart Biopharmaceutical has announced a major milestone with the first patient dosing in a registrational Phase I clinical trial in China for its investigational therapy, XS228 Cell Injection. The company claims this marks the world’s first such dosing for an “off-the-shelf,” allogeneic, iPSC-derived spinal neural progenitor cell therapy aimed at treating spinal cord injury (SCI). The trial is dual-registered with China’s NMPA and the U.S. FDA.

The initial patient exhibited a positive safety profile, with no surgical or other adverse events, and has successfully entered the follow-up period. This landmark event will help establish a safety benchmark for this new type of therapy.

Advancing a Broad Pipeline of iPSC-Derived Therapies

This milestone for SCI is part of XellSmart’s larger clinical strategy to develop iPSC-derived cell therapies for central nervous system (CNS) diseases that have no effective treatments. To date, the company has secured seven Investigational New Drug (IND) approvals from both the NMPA and the FDA.

The company’s pipeline includes:

• Parkinson’s Disease (PD): A Phase I clinical trial is ongoing in China, with approval also secured in the U.S.
• Spinal Cord Injury (SCI): A Phase I clinical trial is ongoing in China, with approval in the U.S.
• Amyotrophic Lateral Sclerosis (ALS): A Phase I/II clinical trial is ongoing in China, with U.S. approval and Orphan Drug Designation from the FDA. The company has already treated the world’s first ALS patient with this therapy in a previous study.

The company’s platform focuses on developing clinical-grade, off-the-shelf, allogeneic, iPSC-derived cell therapies.