Parkinson's Disease Clinical Trial
Official title:
A Single-arm, Open-label, Single-center Trial, Evaluating the Safety and Efficacy of BBM-P002 for Primary Advanced Parkinson's Disease
Safety and Efficacy Study of BBM-P002 in subjects with primary advanced Parkinson's disease
Status | Not yet recruiting |
Enrollment | 6 |
Est. completion date | December 30, 2028 |
Est. primary completion date | May 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Diagnosed with idiopathic Parkinson's disease. 2. Males and females, 40 to 70 years of age (inclusive). 3. Disease duration from diagnosis of =5 years. Responsiveness to dopamine. 4. Good compliance and regular follow-up. Completion of Parkinson's disease patient diary accurately during follow-up, and family members, guardians or caregivers can help subjects fill in patient diary. Exclusion Criteria: 1. Atypical or secondary parkinsonism. 2. History of coagulopathy, abnormal bleeding or hemopathy family history. Other bleeding risk which increases risk of surgery determined by investigator. 3. Any type of prior gene therapy. 4. Clinically significant electrocardiogram (ECG) abnormalities. 5. Concomitant disease including unstable cardiovascular and cerebrovascular diseases within 3 months, uncontrolled hypertension, sever postural hypotension, poorly controlled diabetes, history of malignancy. 6. Acute or chronic: hepatitis B (HBV); hepatitis C (HCV) infection must have completed curative antiviral treatment with HBV/HCV viral load below the limit of quantification or be negative due to prior treatment or natural resolution to be eligible for enrollment. Subject with Human Immunodeficiency Virus (HIV) or Syphilitic serum positive should be excluded. |
Country | Name | City | State |
---|---|---|---|
China | Xiangya Hospital of Central South University | Changsha | Hunan |
Lead Sponsor | Collaborator |
---|---|
Xiangya Hospital of Central South University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Adverse Events and Serious Adverse Events | Safety and Tolerability of BBM-P002 assessed by Adverse Events and Serious Adverse Event | Day 1 through week 52 | |
Primary | Post-treatment MRI assessment | Incidence of parenthetical toxicity in the infusion region or elsewhere throughout the brain on MRI | Day 1 through week 52 | |
Secondary | Efficacy of BBM-P002 | Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | Change from Baseline to Week 52 |
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