Xellsmart’s iPSC Therapy XS-228 Receives FDA Approval for ALS Study

Suzhou-based stem-cell startup Xellsmart announced that the U.S. FDA has approved its regulatory study of XS-228, an iPSC-derived neural precursor cell therapy, for amyotrophic lateral sclerosis (ALS). The therapy, designed to provide a universal cell treatment for ALS patients, received orphan drug designation (ODD) from the FDA in December 2023.

Therapy Profile
XS-228 aims to offer a safe, efficacious, and controllable clinical solution for ALS. The therapy is also under clinical review in China for ALS treatment.-Fineline Info & Tech