NCT06608355

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: iRegene Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
BIOLOGICAL	Human Dopaminergic Progenitor Cells	Single injection of Human Dopaminergic Progenitor Cells into the putamen of brain.

Timeline

• Start date: 2024-08-23
• Primary completion: 2026-04-01
• Completion: 2027-03-01
• First posted: 2024-09-23
• Last updated: 2024-11-07

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study