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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

NCT05094011•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

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.

Eligibility

Age

45 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Provision of signed and dated informed consent form
•Aged 45 to 70 years old (inclusive) at Screening
•Idiopathic Parkinson's disease patients who meet the diagnostic criteria of the "Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease"
•With at least 5 years since the diagnosis of Parkinson's disease
•With responsiveness to levodopa or dopa agonist. This is defined as improvement between ''Off'' and ''On'' MDS-UPDRS by at least 33% of the Motor MDS-UPDRS
•Idiopathic Parkinson's disease of Stage 3 \~ 4 of modified Hoehn \& Yahr staging during ''ON'' time
•Stable Parkinsonian medications for at least 2 months prior to the Screening Visit
•MRI not showing gross atrophy or any brain pathology other than PD
•Mini-Mental State Examination (MMSE) ≧ 24
•With score of the Beck Depression Inventory (BDI-II) \< 29 and Hamilton Rating Scale for Depression (HAM-D-17) \< 25

Exclusion Criteria

•Atypical or secondary Parkinsonism
•With neurodegenerative disorders other than PD
•Unable to receive MRI or PET scanning
•With any concomitant disorder that would contraindicate coagulation, general anesthesia, or stereotactic neurosurgery
•Received any other investigational agent within 4 weeks prior to Screening
•History of intracranial surgeries or implantation of a device for Parkinson's disease 2 years prior to Screening
•Major surgery within the previous 6 months at Screening
•Significant cardiovascular disease, including:
•* New York Heart Association (NYHA) class III or IV congestive heart failure
•* Uncontrolled hypertension: Blood pressure \>140/90 mmHg
+30 more criteria

Key Dates

Start Date

March 1, 2026

Primary Completion Date

September 30, 2027

Completion Date

July 31, 2028

Last Updated

November 21, 2024

Enrollment

ESTIMATED participants

Conditions

Idiopathic Parkinson's Disease

Interventions

Aadipose-Derived Mesenchymal Stem Cells

BIOLOGICAL

Contacts

Kuo-Wei Hsueh, Ph. D.

CONTACT

886-03-5820208 fskenneth@taimito.com

Zong-Han Lu, Master

CONTACT

886-03-5820208 zhlu@taimito.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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