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Phase I Clinical Study of NouvNeu001 Injection for the Treatment of Moderate-to-Advanced Parkinson's Disease in Patients Who Have Previously Undergone Deep Brain Stimulation or Deep Brain Nucleus Lesioning Surgery

NCT07550374 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-24

No results posted yet for this study

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 who have previously undergone deep brain stimulation or deep brain nucleus lesioning surgery.

Conditions

  • Parkinson's Disease (PD)

Interventions

BIOLOGICAL

NouvNeu001 injection

NouvNeu001 injection is a Human Dopaminergic Progenitor Cell injection, administered as a single injection into the putamen/striatum region of the brain.

Sponsors & Collaborators

  • iRegene Therapeutics Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-04-30
Completion
2031-07-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07550374 on ClinicalTrials.gov