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An Exploratory Clinical Study of UX-DA001 in Subjects With Idiopathic Parkinson's Disease
An Exploratory Clinical Study of UX-DA001 in Subjects With Idiopathic Parkinson's Disease
Active Not RecruitingPhase 1
Sponsor: Shanghai UniXell Biotechnology Co., Ltd
Conditions: Parkinson Disease, Idiopathic
Interventions: UX-DA001
Countries: China
This clinical study is designed to explore the safety and tolerability of UX-DA001. It will also explore if UX-DA001 works to improve motor function in subjects with Parkinson's disease. UX-DA001 manufactured from participant's own cells will differentiate into mature dopaminergic neurons after being transplanted into the brain of the participant.
Eligibility overview
Sex: ALL
Age: 50 Years to 75 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: 1. The subjects or their legally acceptable representative understand and comply with the study procedures, agree to participate in the clinical trial, and sign the ICF; 2. Aged between 50-75 years old, male or female; 3. Subjects diagnosed with idiopathic PD, with a medical history of 5-20 years; 4. Having received standard anti-PD treatment and been given optimal anti-PD treatment under the guidance of the investigator, but the efficacy has significantly declined; 5. Good response to levodopa medications; the LCT shows that the maximum improvement rate of the UPDRS part III score exceeds 30%; 6. The modified H\&Y scale of clinical "OFF" period is ≥ Stage 3 and ≤ Stage 4; 7. Taking a stable dosage of anti-PD medications for at least 4 weeks; 8. Good physical condition or stable concomitant diseases; 9. With reliable caregivers who can cooperate to complete the assessment items; 10. Subjects with good compliance. Exclusion Criteria: 1. PD Subjects in whom previous genetic testing has found a GBA gene mutation or PD Subjects whom the investigator considers unsuitable for participation in this clinical study due to other gene mutations; 2. Subjects with the atypical Parkinson's syndrome or secondary Parkinson's syndrome; 3. Subjects with HIV, HBV, HCV, treponema pallidum (TP) infection, or other active infections; 4. Subjects infected with HTLV, EBV or CMV whose infection renders their blood cells unsuitable for cell product preparation; 5. Subjects with a known hereditary disorder; 6. Subjects with any history of malignancy; 7. Subjects with other serious systemic diseases or functional disorders; 8. Accompanied by other serious central nervous system diseases or serious cognitive and mental disorders; 9. Subjects who are currently receiving or have previously received cell therapy or other medicine effecting safety and efficacy assessement; 10. Subjects whose prior head CT/MRI examinations indicate brain injury, or Subjects with imaging abnormalities in the striatum and other brain regions leading to a significant increase in surgical risk, or Subjects who have previously undergone brain surgery; 11. Subjects with clinically significant abnormal results in coagulation function, or Subjects who have been using anticoagulants for a long time and cannot discontinue use; 12. Subjects with a history of severe allergy or hypersensitivity reactions, or a known history of hypersensitivity, or a history of intolerance to the investigational cellular drug or its excipients; 13. Subjects who have undergone other surgeries within the past six months that the investigator deems may affect this trial, or Subjects who cannot tolerate general anesthesia or stereotactic surgery; 14. Subjects with contraindications to MRI and PET scans; 15. Subjects with a history of alcoholism or drug abuse; 16. Women during pregnancy or lactation; 17. Subjects who have participated in other interventional clinical trials or similar clinical trials within the past 3 months; 18. Subjects with other conditions that are not suitable for participation in the clinical study as judged by the investigator.
Locations (1)
- Shanghai, Shanghai Municipality, China