This clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of a single injection of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in patients with Parkinson's Disease who have previously undergone deep brain stimulation or deep brain nucleus lesioning surgery.
Age ≥18 years and ≤70 years, male or female.
The subject understands and agrees to comply with the study procedures, voluntarily participates, and signs the informed consent form.
Primary Parkinson's disease (meeting the diagnostic criteria of the International Parkinson and Movement Disorder Society [MDS]), and the subject has previously undergone deep brain stimulation (DBS) or deep brain nucleus lesioning surgery.
With DBS turned off, the MDS Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) motor examination score in the "off" state is ≥30; and the levodopa challenge test is positive (improvement rate in UPDRS-III score ≥30%).
Atypical or secondary parkinsonism confirmed by the investigator to be caused by medication, metabolic disorders, or other conditions.
Presence of persistent active infection in the previous brain surgery area, cerebrospinal fluid (CSF) leakage, or unhealed wounds; presence of implanted device malfunction, electrode displacement, etc., which in the investigator's judgment poses a significant risk to the subject or affects evaluation; contraindications to MRI (e.g., intracranial implants, cochlear implants, cardiac pacemaker/defibrillator, etc.); any contraindications to surgery or anesthesia as assessed by the investigator; or other surgical conditions that the investigator believes may affect participation in this study.
Significant abnormalities on cranial CT/MRI, including but not limited to: cerebral vascular malformation, vasogenic edema, brain tumor, more than 10 microbleeds, basal ganglia cerebral infarction lesions, etc., which in the investigator's judgment significantly increase surgical risk.
History of severe cardiovascular disease within 1 year prior to screening, including but not limited to: severe heart failure (New York Heart Association Class III or IV, or left ventricular ejection fraction <35% by any method), unstable angina pectoris, myocardial infarction, clinically significant conduction abnormalities (e.g., unstable atrial fibrillation), etc., which in the investigator's judgment may increase surgical risk or render the subject unsuitable for participation.
Sequential
NouvNeu001 injection
Biological/VaccineNouvNeu001 injection is a Human Dopaminergic Progenitor Cell injection, administered as a single injection into the putamen/striatum region of the brain.
Incidence and severity of Adverse Events as Assessed by CTCAE V5.0
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Changes from baseline in the MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score, as well as MDS-UPDRS Parts I, II, III (off state and on state), and IV scores at 12, 24, 36, 48, 72, and 96 weeks after administration.
Change from baseline in the MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score (Part I Score 0 \~ 52 + Part II Score 0 \~ 52 + Part III Score 0 \~ 72 + Part IV Score 0 \~ 24) at Weeks 12, 24, 36, 48, 72, and 96. A higher score indicates more severe symptoms or worse health.
Changes from baseline in the Modified Hoehn and Yahr Staging at 12, 24, 36, 48, 72, and 96 weeks after administration
Change from baseline in the Modified Hoehn and Yahr Staging (0, 1, 1.5, 2, 2.5, 3, 4, 5) at Weeks 12, 24, 36, 48, 72, and 96. A higher Stage indicates more severe symptoms or worse health.
Changes from baseline in the Hamilton Depression Rating Scale (HAMD) score at 12, 24, 36, 48, 72, and 96 weeks after administration
Change from baseline in the Hamilton Depression Rating Scale (HAMD) score (0 \~ 53) at Weeks 12, 24, 36, 48, 72, and 96. A higher score indicates more severe symptoms or worse health.
Changes from baseline in the Parkinson's Disease Questionnaire (PDQ-39) score at 12, 24, 36, 48, 72, and 96 weeks after administration
Change from baseline in the Parkinson's Disease Questionnaire (PDQ-39) score (0 \~ 156) at Weeks 12, 24, 36, 48, 72, and 96. A higher score indicates more severe symptoms or worse health.
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