RecruitingPhase 1NCT07102342

This Clinical Trial is Designed to Evaluate the Safety, Tolerability, Feasibility and Preliminary Efficacy of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in Patients With Parkinson's Disease.

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Feasibility, and Preliminary Efficacy of NouvNeu001 in Patients With Advanced Parkinson's Disease.


Sponsor

iRegene Therapeutics Co., Ltd.

Enrollment

5 participants

Start Date

Jan 12, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 1 clinical study to evaluate the safety, tolerability, feasibility, and preliminary efficacy of NouvNeu001 in patients with advanced Parkinson's Disease.


Eligibility

Min Age: 30 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new cell-based treatment called NouvNeu001 — human dopamine-producing brain cells injected into the brain — to see if it is safe and may slow or improve symptoms in people with Parkinson's disease. **You may be eligible if...** - You are between 30 and 75 years old - You were diagnosed with Parkinson's disease 4 to 20 years ago - Your symptoms are moderate to severe, especially during "off" periods when medication is wearing off - Your symptoms improve meaningfully when you take levodopa - Your medication doses have been stable for at least 4 weeks **You may NOT be eligible if...** - You have significant cognitive decline or dementia - You have had deep brain stimulation (DBS) surgery - You have other neurological conditions that may mimic Parkinson's - You have significant heart, immune, or other major medical conditions 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

BIOLOGICALHuman Dopaminergic Progenitor Cells

Single injection of Human Dopaminergic Progenitor Cells into the biliteral putamen/striatum regions of the brain


Locations(1)

Cornell University Weill Medical College

New York, New York, United States

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NCT07102342


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