XellSmart launched a multicenter Phase II registrational clinical trial of XS411, an allogeneic, off-the-shelf iPSC-derived dopaminergic neural progenitor cell therapy for primary Parkinson’s disease, in April 2026, led by Beijing Tiantan Hospital, with collaborators including Peking Union Medical College Hospital and the Second Affiliated Hospital of Soochow University.
The randomized, prospective, standard treatment–parallel controlled study plans to enroll 30 patients aged 50 to 75 years with disease duration of 5 to 15 years, randomized 2:1 to XS411 or standard anti-Parkinsonian pharmacotherapy, with blinded endpoint assessment and a 12-month primary follow-up; the experimental arm will be followed up to 24 months and control participants may be eligible for later XS411 treatment.
XellSmart reports that Phase I results showed significant improvements in core motor outcomes relative to baseline, longer favorable ON time, improved daily quality of life, increased 18F-DOPA PET-CT uptake in the putamen consistent with graft survival and function, and no adverse events attributed to the transplanted cells.
The company adds that XS411 received clearances in 2025 from China’s NMPA and the US FDA to initiate registrational clinical trials, and that Phase II was approved by relevant ethics committees. The trial is intended to generate more robust evidence of efficacy and safety to support a future Phase III registrational study.
