Actively Recruiting
A Clinical Study to Evaluate the Safety, and Tolerability of BBM-P002 in the Treatment of Parkinson's Disease
Led by Shanghai Xinzhi BioMed Co., Ltd. · Updated on 2026-01-28
18
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to evaluate the safety and tolerability of BBM-P002 for stereotactic injection to treat participants with idiopathic Parkinson's Disease (PD) during the dose-limiting toxicity (DLT) observation period.
CONDITIONS
Official Title
A Clinical Study to Evaluate the Safety, and Tolerability of BBM-P002 in the Treatment of Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Parkinson's disease for 5 years or more
- Hoehn-Yahr stage meets requirements during OFF periods
- MDS-UPDRS Part III score meets requirements during OFF periods with positive levodopa challenge test
- Taking stable dose of dopamine-releasing drugs regularly during screening
- Agree to postpone neurosurgical procedures related to treatment during main study
- Agree not to participate in other therapeutic intervention studies during trial
- Agree not to receive vaccines during main study phase
- Use reliable contraceptive methods from screening until at least 52 weeks post-dose
- Good compliance and ability to attend regular follow-ups and complete diary cards (with possible caregiver help)
- Voluntarily consent to participate and sign informed consent form
You will not qualify if you...
- Atypical or secondary Parkinsonism
- Contraindications for surgery or prior brain surgery
- Abnormal brain MRI suggesting pathology other than Parkinson's disease
- Severe cognitive impairment
- Severe depression or severe anxiety
- Abnormal liver or coagulation function
- Abnormal infectious disease screening
- Currently on antiviral treatment for hepatitis
- Unstable or severe diseases in cardiovascular, respiratory, digestive, nervous, hematological, immune, or other systems
- Current or history of malignant tumors
- History of severe allergies
- Participation in other clinical trials within past 3 months
- Received gene therapy during screening
- Received stem cell treatment within past 12 months
- Used other investigational drugs within past 4 weeks
- Received live vaccines within 2 months before screening or vaccination within last 30 days
- History of alcohol dependence or drug addiction
- Pregnant or lactating females
- Any condition investigator judges unsuitable for study inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
W
Wenshu Luo, Ph.D
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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