RecruitingPhase 1NCT05901818

Safety and Efficacy of Autologous iNSC-DAP in the Treatment of Parkinson's Disease

Safety and Efficacy of Autologous Induced Neural Stem Cell-derived Dopaminergic Precursor Cells in the Treatment of Parkinson's Disease


Sponsor

Xuanwu Hospital, Beijing

Enrollment

10 participants

Start Date

Jun 13, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase I, interventional, single arm, open-label, clinical study to evaluate the safety and efficacy of the striatal transplantation of autologous induced neural stem cell-derived DA precursor cells in Parkinson's Disease patients.


Eligibility

Min Age: 30 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a cell therapy called iNSC-DAP — derived from a patient's own induced neural stem cells — injected into the brain as a potential treatment for Parkinson's disease. It is an early-phase study primarily focused on safety. **You may be eligible if...** - You are between 30 and 85 years old - You have been diagnosed with Parkinson's disease according to standard medical criteria - You have had Parkinson's for more than 3 years - Your disease is at Hoehn and Yahr Stage 4 or below when your medication is working ("on" state) - You respond to levodopa treatment (at least 30% improvement in motor symptoms) **You may NOT be eligible if...** - You have atypical or secondary Parkinsonism (not classic Parkinson's disease) - You have other serious brain or nervous system diseases - You have significant psychiatric illness or cognitive impairment (MMSE below 24) - You have had prior brain surgery - You take blood thinners long-term and cannot stop Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAutologous induced neural stem cell-derived DA precursor cells

The autologous induced neural stem cell-derived DA precursor cells will be stereotactically implanted into the striatum of PD patients.


Locations(1)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

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NCT05901818


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