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Evaluating Safety, Tolerability, and Efficacy of Autologous MitoCell Transplantation in Subjects With Idiopathic Parkinson's Disease
Sponsor: Taiwan Mitochondrion Applied Technology Co., Ltd.
Summary
Primary Objective: To assess the safety profile of autologous MitoCell administered to subjects with idiopathic Parkinson's disease (PD) Secondary Objective: To explore the efficacy and safety of MitoCell given as the recommended dose by stereotactic intrastriatal implantation
Official title: A Phase I Open-Label Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of Autologous MitoCell (Adipose-Derived Mesenchymal Stem Cells) Transplantation in Subjects With Idiopathic Parkinson's Disease
Key Details
Gender
All
Age Range
45 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
9
Start Date
2026-03-01
Completion Date
2028-07-31
Last Updated
2024-11-21
Healthy Volunteers
No
Conditions
Interventions
Aadipose-Derived Mesenchymal Stem Cells
Stereotactic intrastriatal implantation of 3×10\^7 per hemisphere (total 6×10\^7 cells) or 1×10\^8 per hemisphere (total 2×10\^8 cells) autologous TM01-treated adipose-derived mesenchymal stem cells (MitoCell).