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

NCT06608355 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-11-07

No results posted yet for this study

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.

Conditions

  • Early-onset Parkinson's Disease

Interventions

BIOLOGICAL

Human Dopaminergic Progenitor Cells

Single injection of Human Dopaminergic Progenitor Cells into the putamen of 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
2024-08-23
Primary Completion
2026-04-30
Completion
2027-03-31
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 NCT06608355 on ClinicalTrials.gov