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NOT YET RECRUITING
NCT05094011
PHASE1

Evaluating Safety, Tolerability, and Efficacy of Autologous MitoCell Transplantation in Subjects With Idiopathic Parkinson's Disease

Sponsor: Taiwan Mitochondrion Applied Technology Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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).