Trials / Not Yet Recruiting
Not Yet RecruitingNCT07028632
The Safety, Feasibility 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
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (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 using stereotactic neurosurgery. Subjects will take immunosuppressants to prevent potential immune rejection for 24 to 36 weeks.
Conditions
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
- 2025-06-30
- Primary completion
- 2026-12-01
- Completion
- 2030-12-01
- First posted
- 2025-06-19
- Last updated
- 2025-06-29
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07028632. Inclusion in this directory is not an endorsement.