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Study to Evaluate the Safety and Efficacy of ESC-derived Dopamine Progenitor Cell Therapy in PD Patients
Sponsor: S.Biomedics Co., Ltd.
Summary
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.
Official title: A Single Center, Open, Single Dosing, Dose-escalation, Phase 1/2a Study to Evaluate the Safety and Exploratory Efficacy of Embryonic Stem Cell-derived A9 Dopamine Progenitor Cell (A9-DPC) Therapy in Patients With Parkinson's Disease
Key Details
Gender
All
Age Range
50 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2023-05-09
Completion Date
2025-12-10
Last Updated
2026-04-13
Healthy Volunteers
No
Conditions
Interventions
Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) Low Dose
Biological/Vaccine: Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC)\_Low Dose 1. IP Name : Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) 2. Main ingredients and quantities: A9-DPC -Low Dose : 7.0X10\^6 cells (Use 3.15X10\^6 cells of this) 3. Formulation: milky white cell suspension 4. Storage method: Refrigerated storage (5±3#) 5. Expiration date: within 36 hours of manufacture 6. Frequency: single dosing 7. Method: The subject pierces a burr hole in the skull on the day of surgery. Then the cells are injected at a predetermined stem cell administration point of the putamen in the brain of the subject. One side is administered in three tracks per putamen (6 tracks total brain). Do the same for the other side.
Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) High Dose
Biological/Vaccine: Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC)\_High Dose 1. IP Name : Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) 2. Main ingredients and quantities: A9-DPC -High Dose : 1.4X10\^7 cells (Use 6.30X10\^6 cells of this) 3. Formulation: milky white cell suspension 4. Storage method: Refrigerated storage (5±3#) 5. Expiration date: within 36 hours of manufacture 6. Frequency: single dosing 7. Method: The subject pierces a burr hole in the skull on the day of surgery. Then the cells are injected at a predetermined stem cell administration point of the putamen in the brain of the subject. One side is administered in three tracks per putamen (6 tracks total brain). Do the same for the other side.
Locations (1)
Yonsei University Health System, Severance Hospital
Seoul, South Korea