drugset / Trial / NCT06608355

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

NCT06608355 ↗

Phase 1 Recruiting 6 enrolled iRegene Therapeutics Co., Ltd.
NaSequentialOpen-labelTreatment

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.

Timeline

Start
2024-08-23
Primary completion
2026-04
Completion
2027-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Human Dopaminergic Progenitor Cells Cell therapy — Other

Indications