XellSmart Reports Parkinson's Cell Therapy Phase I Results and Completes Phase II Enrollment
XellSmart has presented Phase I clinical data for its off-the-shelf Parkinson's disease cell therapy, XS411, and completed enrollment for a blinded Phase II trial in China.
Seoul, South Korea and Shanghai – XellSmart, a biopharmaceutical company, has presented Phase I clinical data for its experimental cell therapy candidate, XS411, for Parkinson's disease. The results were shared at the International Congress of Parkinson's Disease and Movement Disorders (MDS).
The company also announced the completion of patient enrollment for its multicenter, randomized, parallel-group Phase II trial in China. This trial uses an open-label design with blinded endpoint assessment.
XS411 is an allogeneic cell therapy comprising induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cells. It is designed for use without patient-specific HLA matching and is administered with a standardized immunosuppressive regimen, aiming to restore dopamine synthesis and metabolism.
The Phase I trial, involving nine participants with moderate-to-advanced Parkinson's disease, demonstrated significant motor function improvements six months post-transplant, including an average increase of over five hours of "ON" time daily. The trial met its primary safety and tolerability objectives, with XS411 generally well-tolerated and no dose-limiting toxicities or serious adverse events reported. Molecular imaging using ¹⁸F-DOPA PET confirmed increased tracer uptake at the transplant site, indicating restored dopamine synthesis.