First Global Registrational Clinical Trials for Parkinson’s, ALS, and Spinal Cord Injury Launched with Subtype-Specific iPSC-Derived Cell Products

XellSmart, a pioneering biotech company, has rapidly emerged as a global leader in the development of regenerative cell therapies based on induced pluripotent stem cells (iPSCs) for central nervous system (CNS) disorders. Over the past three years, the company has achieved multiple national and international milestones, transforming the treatment landscape for Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and spinal cord injury (SCI).

 Key Milestones of XellSmart

 2023

China's first iPSC-derived cell therapy, XS228 injection, received official FDA approval in the United States.

The product was also granted Global Orphan Drug Designation (ODD) for ALS.

2024

China's first national-level registered clinical study using iPSC-derived cells for Parkinson’s disease began, with the first patient treated. Over 12 months of follow-up showed excellent safety and significant improvements in motor and non-motor symptoms.

The world’s first registered iPSC-based clinical study for ALS also launched, demonstrating early signs of slowed disease progression in multiple patients.

 2025

China’s first Phase I registrational trial of allogeneic iPSC-derived dopaminergic neural progenitor cells (XS411 injection) began for Parkinson’s disease.

The first randomized, double-blind, controlled Phase I/II trial targeting early-onset Parkinson’s disease (EOPD) was launched.

The world’s first registrational Phase I/II trial of iPSC-derived neural progenitors (XS228) for ALS was initiated by Peking University Third Hospital.

The world’s first registrational Phase I clinical trial of iPSC-derived neural progenitor therapy for spinal cord injury (SCI) was launched by the Third Affiliated Hospital of Sun Yat-sen University.

About XellSmart

XellSmart is an innovation-driven biotechnology company focused on developing off-the-shelf, allogeneic, and subtype-specific iPSC-derived cell therapies for CNS diseases with high unmet medical needs. With its proprietary platforms and in-house technologies, XellSmart is committed to delivering next-generation regenerative solutions to patients worldwide.

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