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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:
• 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;
Locations
Other Locations
China
The First Affiliated Hospital of USTC
RECRUITING
Hefei
Time Frame
Start Date: 2025-06-06
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 48
Treatments
Experimental: Low Dose
MRI-guided bilateral stereotactic cell implantation
Experimental: High Dose
MRI-guided bilateral stereotactic cell implantation
Related Therapeutic Areas
Sponsors
Leads: Nuwacell Biotechnologies Co., Ltd.