UX-DA003: UX-DA003 (Human Allogeneic iPSC-derived Midbrain Dopaminergic Progenitor cells) is used for treating patients with PD via implanting into bilateral putamina under stereotactic neurosurgery.
Study summary
This clinical study is designed to explore the safety and tolerability of UX-DA003. It will also explore if UX-DA003 works to improve motor function in subjects with Parkinson's disease.
Eligibility
Sex
ALL
Min age
30 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Aged between 30 and 75 years, regardless of gender
* Diagnosed with Parkinson's disease conforming to relevant clinical diagnostic standards with a medical history of 5-20 years
* 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
* Good response to levodopa medications, the levodopa challenge test (LCT) shows that the maximum improvement rate of the UPDRS-III score exceeds 30%
* The modified H\&Y staging (Off period) of ≥2.5 and ≤4, with total daily "off" time \>2 hours
* Stable dose of anti-Parkinson' disease drugs for at least 4 weeks prior to screening
* Good physical condition or stable concomitant diseases
Exclusion Criteria:
* The subjects with atypical Parkinson's syndrome or secondary Parkinson's syndrome
* Severe systemic diseases or functional impairments
* Evidence of active infection or chronic infection, which may pose a risk to the subject
* Severe concomitant central nervous system diseases or severe cognitive and psychiatric disorders
* Subjects with a history of brain injuries, cerebral vascular malformations, hydrocephalus, brain tumors, or other brain damages as shown by previous Head CT/MRI scans, or subjects with abnormal brain imaging in the striatum or other brain regions that significantly increase surgical risks
* Subjects who have participated in clinical trials for stem cell therapy or gene therapy for Parkinson's disease, or have participated in other interventional clinical trials within the last 3 months
* Subjects with a history of severe allergies or hypersensitivity reactions, known hypersensitivity to the investigational drug or its ancillary materials, or intolerance to them
* Pregnant or breastfeeding women
Primary outcome measure(s)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) — Within 6 months after administration
Trial sites (1)
Facility
City
Region
Status
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
China
More Shanghai UniXell Biotechnology Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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