Huashan Hospital Fudan University

XellSmart Secures Fourth Consecutive FDA and NMPA Approval for iPSC Cell Therapy Targeting Rare Neurodegenerative Disease MSA-P

- XellSmart received its fourth consecutive US FDA and China NMPA clearance for Phase I/II clinical trials of an iPSC-derived cell therapy targeting Multiple System Atrophy-Parkinsonian Type (MSA-P), a rare and fatal neurodegenerative disease. - The company now has nine approved INDs for iPSC-derived cell therapies targeting major CNS diseases including Parkinson's disease, spinal cord injury, ALS, and MSA-P, demonstrating significant regulatory confidence. - Clinical data from XellSmart's Parkinson's disease trials showed promising safety and efficacy signals, with patients experiencing extended "ON state" periods and improved motor function scores. - MSA-P patients face a median survival of only 6-10 years after diagnosis, with no currently approved therapies that can effectively slow or reverse disease progression worldwide.