NCT06608355
The Safety, Tolerability and Preliminary Efficacy of NouvNeu001 for Early-onset Parkinson's Disease
Recruiting · Phase 1 · iRegene Therapeutics Co., Ltd. · registry updated 2024-11-07
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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.
- Hoehn-Yahr staging for "off" episodes is 2 to 4
- The MDS-UPDRS-III score in the "off" state \>30, and positive for the Acute Levodopa Challenge Test (ALCT)
Exclusion
- 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
- Patients with a history of malignant tumors
- Patients who have received stem cell therapy for Parkinson's disease within 2 years before signing the ICF