The goal of this clinical trial is to learn about the safety of NouvNeu001 injection in Early-onset Parkinson's Disease (EOPD) patients. It will also learn about the effects of NouvNeu001 treatment. The main questions it aims to answer are:
What medical problems do participants have when transplanting NouvNeu001 into bilateral putamen using stereotactic neurosurgery? Does injection of NouvNeu001 improve the motor function and non-motor function in participants?
Participants will:
Be injectioned the NouvNeu001 into bilateral putamen using stereotactic neurosurgery.
Take immunosuppressants to prevent potential immune rejection for 24 to 36 weeks.
Age 18-70 years old, male or female
Able to understand the rationale of the clinical trial and sign informed consent form (ICF)
Diagnosis of Early-onset Parkinson's Disease in accordance with the MDS clinical diagnostic criteria for Parkinson's disease, and the age of onset was ≤50 years old
Medically suitable for neurosurgery under anesthesia and able to participate in Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) scan.
Atypical Parkinsonism
Patients who have had previous pallidotomy, striatal or extrapyramidal surgery or other brain surgery; as well as other surgical procedures that are judged by the investigator to affect patient's participation in this study; Patients with surgical contraindications or other neurosurgical contraindications
Patients who have a previous head CT/MRI examination showing cerebral trauma, vascular malformation, hydrocephalus, brain tumor, etc., and patients who have brain imaging abnormalities in the striatum or other brain areas leading to a significantly increased risk for surgery
Patients with a history of severe cardiovascular and cerebrovascular diseases
Sequential
Human Dopaminergic Progenitor Cells
Biological/VaccineSingle injection of Human Dopaminergic Progenitor Cells into the putamen of brain.
Safety and Tolerability
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
The Motor Function and Non-motor Function
Changes in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I-IV Score from baseline. A higher score indicates more severe symptoms or worse health.
Positron Emission Tomography Imaging
Change in uptake value from baseline using positron emission tomography (PET).
Dopamine Metabolism
Change in the levels of dopamine and its metabolites from baseline.
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