Actively Recruiting
This Clinical Trial is Designed to Evaluate the Safety, Tolerability, Feasibility and Preliminary Efficacy of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in Patients With Parkinson's Disease.
Led by iRegene Therapeutics Co., Ltd. · Updated on 2026-05-11
5
Participants Needed
1
Research Sites
346 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase 1/2 clinical study to evaluate the safety, tolerability, feasibility, and preliminary efficacy of NouvNeu001 in patients with advanced Parkinson's Disease.
CONDITIONS
Official Title
This Clinical Trial is Designed to Evaluate the Safety, Tolerability, Feasibility and Preliminary Efficacy of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in Patients With Parkinson's Disease.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 30 to 75 years at consent signing
- Diagnosed with Parkinson's Disease between 4 and 20 years ago meeting MDS 2015 criteria
- Hoehn and Yahr stage 2.5 to 4.0 during OFF episodes
- MDS-UPDRS-III score greater than 35 and positive acute levodopa challenge test with improvement over 30%
- Stable MDS-UPDRS-III scores between two screening visits
- Stable dopamine drug dose for at least 4 weeks before receiving study drug
- Stable dose and schedule of Parkinson's medicines during screening
- Medically suitable for neurosurgery under general anesthesia
- Acceptable lab test results before transplantation including neutrophil count, blood cell counts, liver and kidney function
- Will postpone other neurosurgeries including DBS for 12 months after surgery
- Will not join other therapeutic intervention studies for 24 months post surgery
- Able to attend all study visits and evaluations including brain/spine MRI, CT, and PET scans
- Body mass index between 18 and 32 kg/m2 with minimum weight of 45 kg
- Agree to use contraception for 12 months after neurosurgery as per local regulations
- Able to understand the clinical trial and sign informed consent
- Agree not to receive COVID-19 vaccine within 14 days before surgery and no other vaccines within 30 days after surgery
You will not qualify if you...
- Diagnosis of atypical parkinsonism or Parkinsonism-Plus syndrome
- Previous brain or spinal surgery including pallidotomy, DBS, or stereotaxy
- Brain imaging showing trauma, malformation, tumor, or abnormalities increasing surgery risk
- Previous cellular therapy
- Recent use of high-dose or prolonged glucocorticoids or immunosuppressants
- Recent use of antipsychotics, antidepressants, or botulinum toxin affecting assessments
- Participation in other clinical trials within 3 months before screening
- History of dementia, severe cognitive impairment, or poor compliance
- Severe depression (HAMD score ≥ 24) or severe anxiety (HAMA score ≥ 29)
- Psychiatric disorders, suicidal ideation or attempts within past year
- Abnormal coagulation or need to continue anticoagulant medications through surgery
- Active disseminated intravascular coagulation or significant bleeding tendency
- History of severe heart failure, unstable angina, serious arrhythmia, long QT syndrome, cardiovascular surgery, stroke or transient ischemic attack within 3 months
- Neurodegenerative diseases like Alzheimer's, major vascular diseases, malignant tumors, immune dysfunction, epilepsy
- Poorly controlled hypertension or diabetes
- Significant kidney, liver, or immunological abnormalities
- Neurosurgical contraindications such as implants or recent surgeries impacting trial
- Severe systemic diseases like pulmonary heart disease, severe asthma, COPD
- Recent serious infections or active infections including HIV, COVID-19, syphilis, hepatitis, tuberculosis
- Alcohol or drug addiction
- Allergy to any medicines used in neurosurgery or study drugs including immunosuppressants or levodopa
- Women of childbearing potential not using effective contraception or lactating women; men unwilling to use contraception
- Recent electric shock therapy within 30 days before surgery
- Treatment with certain Parkinson's drugs like neuroleptics, apomorphine, or levodopa/carbidopa infusion
- Severe dyskinesia in ON and OFF drug states
- Recent live vaccine within 4 weeks
- Other significant medical or conditions judged unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cornell University Weill Medical College
New York, New York, United States, 10065
Actively Recruiting
Research Team
M
Meng Cai, Ph.D
CONTACT
J
Jing Zhao, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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