Phase III Study of XS411 Stem Cell Injection to Treat Early-onset Parkinsons Disease Evaluating Safety, Tolerability, and Effectiveness in Adults Aged 18 to 70

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of XS411 in treating Early-onset Parkinsons Disease EOPD through a Phase III clinical study. The study includes two phases Phase I uses a single-arm, open-label dose-escalation design to assess safety and find the recommended dose, while Phase II is a randomized, double-blind, sham-controlled trial to further assess efficacy and safety. This research aims to better understand how XS411 may impact EOPD symptoms and progression. In Phase I, 6 to 12 patients receive a single injection of XS411 at one of two dose levels, followed by at least 28 days of observation for safety concerns. Phase II plans to enroll 81 patients randomly assigned in a 21 ratio to either receive XS411 at the recommended dose plus immunosuppressants or a sham procedure plus sham immunosuppressants. This phase will evaluate the treatments effects over time compared to the control group. Participants will be involved in regular assessments including clinical evaluations, questionnaires such as MDS-UPDRS and Hoehn-Yahr scales, and PET-CT scans to monitor changes in dopamine system function. Follow-up visits occur at 28 days, 3, 6, 9, and 12 months after treatment to monitor safety and preliminary effectiveness. The primary outcome focuses on safety and tolerability 28 days after administration, with secondary outcomes assessing symptom changes and brain imaging results during one year of follow-up.

Clinical Study to Evaluate XS411 in Treatment of Early-onset Parkinson's Disease