About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Human Dopaminergic Progenitor Cells