Study to Evaluate the Safety and Efficacy of ESC-derived Dopamine Progenitor Cell Therapy in PD Patients

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

May 9, 2023

Primary Completion Date

February 7, 2024

Study Completion Date

February 7, 2026

Conditions
Parkinson's Disease
Interventions
BIOLOGICAL

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."

BIOLOGICAL

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."

Trial Locations (1)

03722

Yonsei University Health System, Severance Hospital, Seoul

All Listed Sponsors
collaborator

Yonsei University

OTHER

lead

S.Biomedics Co., Ltd.

INDUSTRY