A Phase I Clinical Study on the Safety and Tolerability of iPSC-Derived Dopaminergic Neural Progenitor Cell Injection Via Stereotaxic Brain Transplantation for the Treatment of Primary Parkinson's Disease
This Phase I clinical trial is designed to evaluate the safety, tolerability of a single dose of XS411 (derived dopaminergic neural progenitor cell injection) in patients with primary Parkinson's disease
• Male or female, aged between 50 and 75 years old;
• Diagnosed as 'clinically established PD' consistent with MDS clinical Diagnostic Criteria for Parkinson's disease,
• A minimum of 5 years since diagnosis;
• Hoehn- Yahr score during the off-time is 3 to 4;
• The subjects with an average of at least 2.5 hours of off time per day;
• Stable anti-PD therapy for at least 1 month before screening;
• Anti-PD treatment was once effective, but the efficacy has declined significantly or drug-induced motor complications have occurred, affecting the quality of life;
• Positive levodopa challenge test (MDS-UPDRS-III score improvement from off- state to on- state \> 30%);
• At least three months before the first administration, the subject should have completed all vaccinations as recommended by local authorities;
⁃ The results of complete blood count meet the following conditions: ANC ≥ 2.0×109 /L, WBC ≥ 4.0×109 /L, PLT≥ 100×109 /L, HGB ≥ 10g/dL
⁃ The patient or his/her legal guardian agree to accept the study and signed the informed consent form in writing.