Indication: Patients who were diagnosed with Parkinson's disease ≥ 5 years ago. Purpose: To find the maximum tolerable dose and evaluate the safety and exploratory efficacy of allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) therapy in patients who were diagnosed with Parkinson's disease ≥ 5 years ago, as a treatment for delaying or stopping the progression of Parkinson's disease or inducing recovery of damaged brain. Number of Subjects: Up to 12 subjects. \[Low dose\] 3.15X10\^6 cells/body: 6 subjects. \[High dose\] 6.30X10\^6 cells/body: 6 subjects. Study Design: Single center, open, single dosing, dose-escalation, phase 1/2a study Endpoints: \[Primary Safety Endpoints\] 1. Occurrence of treatment-emergent adverse events (TEAEs) after administration of the IP 2. Failure or rejection of transplantation and occurrence of bleeding and infection at Week 12 (3months), Week 24 (6months), Week 48 (12months) and Week 96 (24months) after administration of the IP 3. Occurrence of adverse event of special interest (AESI)\* after administration of the IP * AESI: a) death, b) generation of a neoplasm or malignant tumor in tissues or organs, c) onset of an immune reaction including worsening of a previous autoimmune disease or new occurrence, and d) other delayed adverse events related to this embryonic stem cell treatment.
Age range
50 Years – 75 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Occurrence of treatment-emergent adverse events (TEAEs) after administration of the IP
Timeframe: Up to 96 Weeks (24 months) after IP administration
Failure or rejection of transplantation
Timeframe: Week 12 (3 months)
Failure or rejection of transplantation
Timeframe: Week 24 (6 months)
Failure or rejection of transplantation
Timeframe: Week 48 (12 months)
Failure or rejection of transplantation
Timeframe: Week 96 (24 months)
Occurrence of bleeding
Timeframe: Week 12 (3 months)
Occurrence of bleeding
Timeframe: Week 24 (6 months)
Occurrence of bleeding
Timeframe: Week 48 (12 months)
Occurrence of bleeding
Timeframe: Week 96 (24 months)
Occurrence of infection
Timeframe: Week 12 (3 months)
Occurrence of infection
Timeframe: Week 24 (6 months)
Occurrence of infection
Timeframe: Week 48 (12 months)
Occurrence of infection
Timeframe: Week 96 (24 months)
Occurrence of adverse event of special interest (AESI)* after administration of the IP
Timeframe: Up to 96 Weeks (24 months) after IP administration