This Clinical Trial is Designed to Evaluate the Safety, Tolerability, Feasibility and Preliminary Efficacy of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in Patients With Parkinson's Disease.
Trial Parameters
Brief Summary
This is a phase 1 clinical study to evaluate the safety, tolerability, feasibility, and preliminary efficacy of NouvNeu001 in patients with advanced Parkinson's Disease.
Eligibility Criteria
Inclusion Criteria: Age • Male or female patient must be 30 to 75 years of age inclusive, at the time of signing the informed consent form (ICF). Type of Patient and Disease Characteristics * Diagnosis of PD between past 4 to 20 years (meet MDS 2015 clinical diagnostic criteria for PD). * H-Y staging (Appendix III) for "OFF" episodes is 2.5-4.0. * MDS-UPDRS-III score \> 35, and positive for the Acute levodopa challenge test (ALCT) (improvement \> 30% for MDS UPDRS-III staging from OFF episodes to ON episodes) over two screening period visits. Baseline scores will be computed as the means of two screening period visits. * No significant change in UPDRS-III scores between the two visits during the screening period. * Patients who take stable doing of dopamine drug for at least 4 weeks prior to receiving the study drug. * No significant change in dose and dosing schedule of the prescribed medicines for PD during the screening period. * Medically suitable for neurosurgery under general ane