RecruitingPhase 1Phase 2NCT06167681

The Safety, Tolerability and Efficacy of NouvNeu001 for Parkinson's Disease

A Phase I/II Study to Assess the Safety, Tolerability and Efficacy of NouvNeu001 Injection for Mid- to Late-stage Parkinson's Disease


Sponsor

iRegene Therapeutics Co., Ltd.

Enrollment

40 participants

Start Date

Jan 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of a single injection of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in patients with Parkinson's disease.


Eligibility

Min Age: 50 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cell transplant treatment called NouvNeu001, where specially prepared cells are injected into the brain to try to slow or improve symptoms of Parkinson's disease. This is an early-phase safety and effectiveness study. **You may be eligible if...** - You are between 50 and 75 years old - You have a confirmed Parkinson's disease diagnosis made 4 to 20 years ago - Your motor symptoms are moderately to severely affected (Hoehn-Yahr stage 2.5 to 4 during "off" periods) - You respond well to levodopa (a standard Parkinson's medication) and score above 35 on the standard motor function scale during "off" periods - You are medically suitable for brain surgery under anesthesia **You may NOT be eligible if...** - You have atypical Parkinsonism (a different type of movement disorder) - You have had previous brain surgery including deep brain stimulation (DBS) - You have a history of severe heart or stroke disease - Brain imaging shows abnormalities that increase surgery risk - You have a history of cancer 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 putamen/striatum region of brain.


Locations(2)

Beijing Hospital

Beijing, Beijing Municipality, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

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NCT06167681


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