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.
• Aged between 30 and 70 years (inclusive), regardless of gender.
• The subject understands and agrees to comply with the study procedures and voluntarily provides written informed consent.
• Diagnosed with pathologically confirmed, clinically established, or clinically probable Multiple System Atrophy (MSA) according to the 2022 MDS diagnostic criteria.
• Current treatments for core MSA symptoms are inadequately controlled.
• The duration of MSA-related motor symptoms (parkinsonism and/or cerebellar ataxia) is no more than 5 years.
• Ability to walk without human assistance, defined as being able to take at least 10 steps; the use of assistive devices (e.g., a walker or cane) is permitted.
• Life expectancy of at least 3 years.
• The subject agrees not to participate in any other clinical studies for 24 months following the investigational product administration.