RecruitingPhase 1NCT07080775

The Safety and Tolerability of XS411CN Injection in Treatment of Primary Parkinson's Disease

A Phase I Clinical Study on the Safety and Tolerability of iPSC-Derived Dopaminergic Neural Progenitor Cell Injection Via Stereotaxic Brain Transplantation for the Treatment of Primary Parkinson's Disease


Sponsor

XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.

Enrollment

12 participants

Start Date

Aug 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This Phase I clinical trial is designed to evaluate the safety, tolerability of a single dose of XS411 (derived dopaminergic neural progenitor cell injection) in patients with primary Parkinson's disease


Eligibility

Min Age: 50 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and tolerability of an injection called XS411CN — a type of cell therapy — as a treatment for Parkinson's disease that has been present for at least 5 years and whose symptoms (especially "off" periods when medication is not working well) are no longer well controlled by current medications. **You may be eligible if...** - You are between 50 and 75 years old and have had established Parkinson's disease for at least 5 years - You experience at least 2.5 hours per day of "off" time (when your medication stops working and symptoms worsen) - Your Parkinson's medications have worked in the past but are no longer as effective, or cause movement side effects - Your blood counts, liver, and kidney function meet required levels **You may NOT be eligible if...** - You have a different type of Parkinson's-like condition (not classic Parkinson's disease) - You have severe cognitive impairment, severe depression, or hallucinations - You have had brain surgery (such as deep brain stimulation) in the past - You have serious heart disease, active infection, cancer history, or uncontrolled autoimmune disease - You are pregnant or breastfeeding 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

DRUGhuman allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection

5.0×10\^7 cells/mL, injection, once, 12 months


Locations(1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

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NCT07080775


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