Last reviewed · How we verify
A Phase I/III Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of Intracerebral Putamen Transplantation of NouvNeu001 Injection for Multiple System Atrophy
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 Multiple System Atrophy.
Details
| Lead sponsor | iRegene Therapeutics Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 9 |
| Start date | 2026-01-05 |
| Completion | 2031-07 |
Conditions
- Multiple System Atrophy - Parkinsonian Subtype (MSA-P)
Interventions
- Human Dopaminergic Progenitor Cells
Primary outcomes
- Incidence and severity of Adverse Events as Assessed by CTCAE V5.0 — 52 weeks post-transplant
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Countries
China