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XS228
- Development stage
- Phase 2
- Lead developer
- XellSmart Biomedical
- Modality
- iPSCs → Pluripotent Stem Cells → Stem Cell Therapies → Cell Therapies, Neural Stem Cells → Tissue-Specific Stem Cells → Stem Cell Therapies → Cell Therapies
- Administration
- Intrathecal
01
Overview
XS228 is an allogeneic, off-the-shelf, clinical-grade cell therapy composed of motor neuron progenitor cells derived from human induced pluripotent stem cells (iPSCs). Developed by XellSmart Biomedical (also referred to as Xellsmart Biopharmaceutical), this therapy is designed for regenerative neural repair. The product is administered via intrathecal injection and aims to replace or support damaged motor neurons in neurodegenerative diseases and spinal cord injuries. XS228 has been granted Orphan Drug Designation by the U.S. FDA for amyotrophic lateral sclerosis (ALS) and represents a first-in-class approach in regenerative medicine for ALS. Early clinical studies have shown that it can slow disease progression in ALS compared to standard care, with a favorable safety profile[2][3][7]. It is also being investigated for spinal cord injury recovery[1][4][8].
- Brand names
- XS228CNXS-228CNXS 228CN
- Other names
- Allogeneic Human Induced Pluripotent Stem Cell-Derived Motor NeuroniPSC-Derived Motor Neuron Cells
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