A Phase I/III Clinical Study to Evaluate NouvNeu001 Injection for Multiple System Atrophy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age30-70
SponsoriRegene Therapeutics Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Neurological diseases/disorders other than Multiple System Atrophy, such as Parkinson's disease, Dementia with Lewy Bodies, Essential Tremor, Progressive Supranuclear Palsy, Spinocerebellar Ataxia, Hereditary Spastic Paraplegia, Corticobasal Degeneration, Vascular Parkinsonism, Normal Pressure Hydrocephalus, or Drug-induced/Postencephalitic Parkinsonism.
Diagnosis of dementia.
Previous or current receipt of other disease-modifying therapies, or participation in clinical trials of other new drugs or novel therapies.
Use of medications within the past 3 months that may affect Parkinsonian symptoms, autonomic function, or the evaluation of safety.
Trial design
Treatments tested in this trial
- Human Dopaminergic Progenitor Cells
Treatment groups
9 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov