Actively Recruiting
Evaluation of GM101 Injection in Patients With Parkinson's Disease
Led by Genemagic Biosciences Co., Ltd · Updated on 2025-08-03
10
Participants Needed
1
Research Sites
246 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this study is to assess the safety of GM101 in participants with Parkinson's disease (PD)
CONDITIONS
Official Title
Evaluation of GM101 Injection in Patients With Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically diagnosed primary Parkinson's Disease according to 2016 Chinese diagnostic criteria
- Able to understand and voluntarily sign informed consent
- Age between 40 and 70 years, any gender
- Body weight between 40 kg and 110 kg; BMI between 18 and 34 kg/m²
- Parkinson's Disease history of 5 years or longer
- Suitable for surgical anesthesia and able to undergo CT/MRI
- Hoehn-Yahr stage 4-5 in "off" state at screening
- MDS-UPDRS-III motor score ≥ 30 in "off" state and positive levodopa challenge test (>30% improvement)
- PD symptoms not controlled or intolerable side effects despite recommended medications
- Stable anti-Parkinson's medication dose for at least 4 weeks before treatment
- Acceptable lab values including hemoglobin, platelets, liver enzymes, bilirubin, and creatinine
- Agree not to participate in other therapeutic studies or clinical trials during this study
- Agree not to receive other vaccines within 30 days after administration
- Able to live independently or with caregiver support and comply with follow-ups
- Pre-existing neutralizing AAV8 antibody titer ≤ 1:90
- Cancer screening as determined by Principal Investigator
You will not qualify if you...
- Atypical parkinsonian syndromes or secondary/hereditary Parkinson's
- Prior brain surgeries affecting study outcomes including pallidotomy, DBS, or stereotactic procedures
- Intracranial lesions increasing surgical risk (e.g., trauma, tumors, malformations)
- History of severe cardiovascular or cerebrovascular diseases or recent stroke/TIA
- History of malignant tumors
- Prior cell or gene therapy
- Active bleeding or coagulation disorders
- Recent high-dose corticosteroid or immunosuppressant use
- Psychiatric disorders or recent suicidal ideation
- Recent botulinum toxin treatment
- Active epilepsy or use of antiepileptic drugs
- Dementia or severe cognitive impairment
- Severe depression or anxiety
- Significant lab abnormalities or poorly controlled hypertension or diabetes
- Surgical contraindications or allergies preventing MRI or neurosurgery
- Severe systemic diseases such as cor pulmonale or severe COPD
- Positive tests for HIV, syphilis, hepatitis, active tuberculosis, or other infections
- Alcohol addiction, drug abuse, or drug dependence history
- Allergies to study drugs or similar medications
- Women of childbearing potential or breastfeeding without effective contraception; men unwilling to use contraception for two years post-treatment
- Recent electroconvulsive therapy
- Participation in other clinical trials within 3 months
- Poor compliance
- Current treatment with apomorphine or levodopa infusion
- Severe movement disorders in medicated and unmedicated states
- Major illnesses or conditions posing safety risks or affecting assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xiangya Hospital, Central South University
Changsha, China
Actively Recruiting
Research Team
K
Kaikai Li, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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