UX-DA003 injections for Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label, dose-escalation exploratory study in mid-to-late stage Parkinson's patients. The trial will assess safety and tolerability of different doses of UX-DA003 injections into the bilateral putamen, with a sentinel-period safety review before advancing to higher doses. Enrollment includes two dose groups (low dose: 3.6×10^6 cells per side; high dose: 5.4×10^6 cells per side), totaling 12 participants. A Safety Monitoring Committee will oversee safety data and guide possible adjustments to enrollment, dosing, or protocol. Participants must have demonstrable levodopa responsiveness and stable anti-PD medication dosages.

Why it matters

Who can join: the full rules

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

Where it's running

• The First Affiliated Hospital of Anhui Medical University Recruiting
  Hefei, Anhui, China Recruiting

Study contacts

• Study coordinator: Jinmei Sun, MD
• Email: sunjinmei0628@163.com
• Phone: +86 0551 62923704

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.