Actively Recruiting
The Safety, Tolerability and Efficacy of NouvNeu001 for Parkinson's Disease
Led by iRegene Therapeutics Co., Ltd. · Updated on 2024-11-01
40
Participants Needed
2
Research Sites
284 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Safety, Tolerability and Efficacy of NouvNeu001 for Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50-75 years old, male or female
- Able to understand the trial and provide informed consent
- Diagnosed with Parkinson's Disease per 2015 MDS clinical criteria
- Diagnosis made between 4 and 20 years ago
- Medically suitable for neurosurgery under anesthesia
- Able to participate in MRI and PET scans
- Hoehn-Yahr stage 2.5 to 4 during "off" episodes
- MDS-UPDRS Part III score > 35 during "off" state and positive Acute Levodopa Challenge Test
- Acceptable lab test results at screening and before transplantation
You will not qualify if you...
- Diagnosis of atypical Parkinsonism
- Previous brain surgeries including pallidotomy, DBS, or other brain stereotaxy
- Brain imaging showing trauma, vascular malformation, hydrocephalus, tumors, or abnormalities increasing surgical risk
- History of severe cardiovascular or cerebrovascular disease
- History of malignant tumors
- Previous cellular therapy
- Active disseminated intravascular coagulation or bleeding tendency within 3 months
- Cannot suspend anti-platelet or anticoagulant medications for at least 5 days before surgery
- Long-term heavy use of glucocorticoids or immunosuppressants within 3 months before consent
- History of mental illness unfit for study or recent suicidal ideation/attempts
- Botulinum toxin use within 6 months before consent
- Active epilepsy or current use of anti-epileptic drugs
- History of dementia or severe cognitive disorder, or MDS-UPDRS 1.1 score > 3 at screening
- Severe depression or anxiety during screening
- Abnormal coagulation or immunological tests unsuitable for participation
- Poorly controlled hypertension or severe postural hypotension
- Poorly controlled diabetes
- Neurosurgical contraindications or recent other surgeries within 6 months affecting study participation
- Severe systemic diseases such as pulmonary heart disease, moderate to severe asthma, or severe COPD
- Positive HIV, syphilis, hepatitis C or active tuberculosis or other infections affecting participation
- Alcohol addiction or positive drug abuse testing
- Allergies to study drugs or macrolides
- Female of childbearing potential not using approved contraception or lactating; males not using approved contraception for 2 years post-treatment
- Electric shock therapy within 30 days before surgery
- Participation in other clinical trials or receiving interventions within 3 months before surgery
- Poor compliance
- Treatment with apomorphine or levodopa/carbidopa infusion
- Severe dyskinesia in both on- and off-drug states
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
2
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
Not Yet Recruiting
Research Team
M
Meng Cai, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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