NCT06167681

The Safety, Tolerability and Efficacy of NouvNeu001 for Parkinson's Disease

A Phase I/II Study to Assess the Safety, Tolerability and Efficacy of NouvNeu001 Injection for Mid- to Late-stage Parkinson's Disease

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: iRegene Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multi-center, single arm, and open label trial. The NouvNeu001 will be transplanted into bilateral putamen/striatum using stereotactic neurosurgery. Subjects will take immunosuppressants to prevent potential immune rejection for 24 to 36 weeks.

Conditions

• Parkinson Disease

Interventions

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

Timeline

• Start date: 2024-01-17
• Primary completion: 2025-12-01
• Completion: 2029-07-01
• First posted: 2023-12-12
• Last updated: 2024-11-01

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study