RecruitingPhase 1NCT06608355

The Safety, Tolerability and Preliminary Efficacy of NouvNeu001 for Early-onset Parkinson's Disease

A Phase I Study to Assess the Safety, Tolerability and Preliminary Efficacy of NouvNeu001 Injection in the Treatment of Early-onset Parkinson's Disease


Sponsor

iRegene Therapeutics Co., Ltd.

Enrollment

6 participants

Start Date

Aug 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn about the safety of NouvNeu001 injection in Early-onset Parkinson's Disease (EOPD) patients. It will also learn about the effects of NouvNeu001 treatment. The main questions it aims to answer are: What medical problems do participants have when transplanting NouvNeu001 into bilateral putamen using stereotactic neurosurgery? Does injection of NouvNeu001 improve the motor function and non-motor function in participants? Participants will: Be injectioned the NouvNeu001 into bilateral putamen using stereotactic neurosurgery. Take immunosuppressants to prevent potential immune rejection for 24 to 36 weeks.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing an experimental cell therapy called NouvNeu001 for people with early-onset Parkinson's disease — meaning Parkinson's that started at age 50 or younger. The treatment involves transplanting specially prepared cells into the brain to try to replace the nerve cells that are lost in Parkinson's disease. This is an early-phase trial focused on safety and initial effectiveness. **You may be eligible if...** - You are between 18 and 70 years old - You were diagnosed with Parkinson's disease and your symptoms first appeared at age 50 or younger - Your Parkinson's symptoms are moderate to severe when your medication has worn off - You responded positively to a levodopa medication test - You are medically fit for brain surgery under anesthesia **You may NOT be eligible if...** - You have atypical Parkinsonism (other conditions that mimic Parkinson's) - You have previously had brain surgery for Parkinson's (e.g., pallidotomy, deep brain stimulation) - Your lab tests fall outside acceptable ranges 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 of brain.


Locations(1)

Tongji Hospital Affiliated to Tongji Medical College Hust

Wuhan, Hubei, China

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NCT06608355