NCT05094011

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Taiwan Mitochondrion Applied Technology Co., Ltd. · Industry
• Sex: All
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed description

MitoCell is an autologous stem cell product that cultures with the company's unique patented medium. The mechanism of action of MitoCell is to improve the brain microenvironment in neurodegenerative disease. MitoCell which like mesenchymal stem cells modulate the immune response, and secrete more BDNF and SDF-1 neurotrophic factors than regular stem cell products.Therefore, MitoCell can protect and repair damaged dopamine neurons (DA) and stimulate DA regeneration.This project is a phase I open-label dose-escalation study to evaluate the safety, tolerability, and efficacy of autologous MitoCell intracranial transplantation in subjects with idiopathic Parkinson's disease which rating from stage 3 \~ 4 of modified Hoehn \& Yahr staging.

Conditions

• Idiopathic Parkinson's Disease

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-09-30
• Completion: 2028-07-31
• First posted: 2021-10-26
• Last updated: 2024-11-21