Actively Recruiting
A Phase I/III Clinical Study to Evaluate NouvNeu001 Injection for Multiple System Atrophy
Led by iRegene Therapeutics Co., Ltd. · Updated on 2026-04-14
9
Participants Needed
1
Research Sites
286 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase I/III Clinical Study to Evaluate NouvNeu001 Injection for Multiple System Atrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 30 and 70 years (inclusive), regardless of gender.
- Understands and agrees to follow study procedures and provides written informed consent.
- Diagnosed with pathologically confirmed, clinically established, or clinically probable Multiple System Atrophy according to 2022 MDS criteria.
- Current treatments for core MSA symptoms are inadequately controlled.
- Duration of MSA-related motor symptoms is no more than 5 years.
- Able to walk without human assistance (at least 10 steps); use of assistive devices allowed.
- Life expectancy of at least 3 years.
- Agrees not to participate in other clinical studies for 24 months after investigational product administration.
You will not qualify if you...
- Diagnosed with other neurological diseases besides Multiple System Atrophy.
- Diagnosis of dementia.
- Previous or current use of other disease-modifying therapies or participation in trials of new drugs or novel therapies.
- Use of medications in the past 3 months that may affect Parkinsonian symptoms, autonomic function, or safety evaluation.
- Presence of significant or unstable medical or surgical conditions that could affect safety or study outcomes.
- History of or current treatment for recurrent stroke.
- Brain MRI showing significant pathological findings except small meningiomas or arachnoid cysts under 1 cm.
- Advanced disease indicated by significant speech, swallowing, walking impairment, or frequent falls.
- History of substance or alcohol abuse within 12 months prior to screening.
- Known allergy to the investigational product or related drugs.
- Positive tests for active viral infections including HIV, Hepatitis B or C.
- Severe liver, kidney, or heart failure.
- Recent history of thrombocytopenia, bleeding disorders, or current anticoagulant therapy (except low-dose aspirin).
- Pregnancy, breastfeeding, or planning pregnancy.
- History of major psychiatric disorders or recent suicidal ideation or attempts.
- Contraindications for surgery or recent neurosurgical procedures affecting the trial.
- Significant cardiac disease within 6 months prior to enrollment.
- Diagnosis of malignancy.
- Family history of congenital or inherited immunodeficiency.
- Considered to have poor compliance.
- Other significant conditions that may risk safety or interfere with assessments.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
M
Meng Cai, Ph.D
CONTACT
J
Jing Zhao, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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