Actively Recruiting
The Safety, Tolerability and Preliminary Efficacy of NouvNeu001 for Early-onset Parkinson's Disease
Led by iRegene Therapeutics Co., Ltd. · Updated on 2024-11-07
6
Participants Needed
1
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Safety, Tolerability and Preliminary Efficacy of NouvNeu001 for Early-onset Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-70 years old, male or female
- Able to understand the clinical trial and sign informed consent
- Diagnosed with Early-onset Parkinson's Disease with onset age 50 or younger
- Medically fit for neurosurgery and able to undergo CT/MRI scans
- Hoehn-Yahr stage 2 to 4 during off episodes
- MDS-UPDRS-III score over 30 in off state and positive Levodopa Challenge Test
- Acceptable lab test results before transplantation
You will not qualify if you...
- Atypical Parkinsonism
- Previous brain or extrapyramidal surgery or other surgery affecting participation
- Brain trauma, vascular malformation, hydrocephalus, brain tumor, or other imaging abnormalities increasing surgery risk
- History of severe cardiovascular or cerebrovascular disease
- History of malignant tumors
- Stem cell therapy for Parkinson's within 2 years before consent
- Active bleeding disorders or inability to stop anticoagulants before surgery
- Long-term heavy use of glucocorticoids or immunosuppressants within 3 months before consent
- History of mental illness, recent suicidal thoughts/attempts, or unfit for study
- Botulinum toxin use within 6 months before consent
- Active epilepsy or use of anti-epileptic drugs
- History of dementia, severe cognitive disorder, poor compliance, or inability to sign consent
- Severe depression or anxiety
- Abnormal coagulation or immune tests, uncontrolled hypertension or blood sugar, severe systemic diseases
- Active infections like HIV, hepatitis B or C, tuberculosis, or other infections affecting participation
- Alcohol addiction or positive drug abuse testing
- Allergy or contraindication to study drugs or components
- Women of childbearing potential not using effective contraception or lactating; men not using contraception
- Electric shock therapy within 30 days before surgery
- Participation in other clinical trials or recent intervention therapies
- Poor compliance
- Treatment with apomorphine or levodopa/carbidopa infusion
- Severe dyskinesia in on and off drug states
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital Affiliated to Tongji Medical College Hust
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
M
Meng Cai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here