RecruitingPhase 1NCT06978920
A Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of NCR201 in the Treatment of Subjects With Parkinson's Disease
A Phase I, Open Label, Single Arm, Dose Escalation and Dose Expansion Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Human Induced Pluripotent Stem Cell Derived Dopaminergic Progenitor Cells (NCR201) Injection in the Treatment of Subjects With Parkinson's Disease
Sponsor
Nuwacell Biotechnologies Co., Ltd.
Enrollment
48 participants
Start Date
Jun 6, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy that NCR201 has on Parkinson's disease (PD) patients.
Eligibility
Min Age: 40 YearsMax Age: 75 Years
Inclusion Criteria5
- Ages between 40 and 75 years;
- Diagnosed to be Parkinson's disease according to Parkinson's disease diagnostic criteria;
- Disease history over 5 years;
- Stable dose of dopamine treatment;
- Able to undergo PET/CT/MRI detection;
Exclusion Criteria6
- Patients who have previously undergone brain surgery;
- Past use of stem cell therapy or participation in stem cell clinical research;
- Cognitive impairment;
- History of mental disorders;
- Patients with other serious systemic diseases;
- Past or current metastatic malignant tumors.
Interventions
DRUGAllogeneic dopaminergic neural precursor cell(NCR201)
Bilateral implantation
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06978920
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