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RECRUITING
NCT06608355
PHASE1

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

Sponsor: iRegene Therapeutics Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2024-08-23

Completion Date

2027-03

Last Updated

2024-11-07

Healthy Volunteers

No

Interventions

BIOLOGICAL

Human 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