Expansion Study of ALT001 in Patients With Multiple System Atrophy
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 75 years old?
Source: NCT07476352, who can take part
Where in China
- Beijing Tiantan HospitalBeijing, ChinaContact: Zhu YahuiTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- yilong Wang
- Trial code
- NCT07476352
- Record updated
- 9 September 2026
- Original description
This is an open-label, single-center, prospective, single-arm clinical study. The primary objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of ALT001 in the treatment of patients with multiple system atrophy (MSA) in a real-world setting.Read full original descriptionShow less
This is an open-label, single-center, prospective, single-arm clinical study. The primary objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of ALT001 in the treatment of patients with multiple system atrophy (MSA) in a real-world setting.
Inclusion: 1. Age between 30 and 75 years inclusive, either sex; 2. Clinically established or clinically probable MSA (including both MSA-C and MSA-P subtypes); 3. Ability to walk independently or with the aid of a walking device for at least 10 meters; 4. Provision of written informed consent.
Exclusion: 3. Presence of immune-mediated diseases that are inadequately controlled or require treatment with biologic agents; 6. Patients with a prior definitive diagnosis of malignancy or those currently receiving anti-tumor drug therapy; 7. Patients with a prior definitive diagnosis of epilepsy or those currently taking anti-epileptic drugs; 1. Evidence of other central nervous system pathologies on brain MRI at screening suggesting a diagnosis of neurodegenerative diseases other than MSA; 2. Other significant pathological findings on brain MRI at screening, including but not limited to: cerebral hemorrhage, acute cerebral infarction, aneurysm, vascular malformation, infectious lesions, brain tumors, or other space-occupying lesions (meningiomas or arachnoid cysts with a maximum diameter <1 cm do not require exclusion); 4. Known history of allergies to biologic agents, such as proteins or cell-based products; 9. Patients with a history of alcohol or substance abuse, or alcohol or substance dependence within the past 2 years; 10. Patients diagnosed with psychiatric disorders according to DSM-V criteria, or those with obvious suicidal intent; 8. Concurrent severe hepatic insufficiency, renal insufficiency, or severe cardiac insufficiency (severe hepatic insufficiency defined as ALT ≥1.5 times the upper limit of normal or AST ≥1.5 times the upper limit of normal; severe renal insufficiency defined as serum creatinine [CRE] ≥1.5 times the upper limit of normal or estimated glomerular filtration rate [eGFR] <40 mL/min/1.73 m²; severe cardiac insufficiency defined as NYHA class 3-4), or any significant abnormalities on physical examination, vital signs, laboratory tests, or electrocardiogram that, in the investigator's opinion, require further examination or treatment, or may interfere with the study procedures or safety; 5. Receipt of any vaccination within the past 1 month; 11. Patients who are pregnant, lactating, or have the potential to become pregnant, or those planning a pregnancy; 12. Inability to comply with follow-up assessments due to other reasons; 13. Patients deemed by the investigator to be unsuitable for participation in this study.