Expansion Study of ALT001 in Patients With Multiple System Atrophy
ConditionMultiple System Atrophy
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age30-75
Sponsoryilong Wang
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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);
3. Presence of immune-mediated diseases that are inadequately controlled or require treatment with biologic agents;
4. Known history of allergies to biologic agents, such as proteins or cell-based products;
Trial design
Treatments tested in this trial
- ALT001
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
yilong Wang
Lead sponsor
Beijing Tiantan Hospital
Sponsor institution
Source ClinicalTrials.gov