Actively Recruiting
The Study of Safety and Preliminary Efficacy of Aleeto in Patients With MultIple System Atrophy
Led by Beijing Tiantan Hospital · Updated on 2025-09-03
20
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, prospective, randomized, open-label, blinded outcome assessment (PROBE) study. At the end of the PROBE study, patients who have completed the study may opt to enter the open-label extension (OLE) study. The objective of the study is to evaluate the safety, tolerability and potential preliminary efficacy of Aleeto in the treatment of patients with multiple system atrophy (MSA).
CONDITIONS
Official Title
The Study of Safety and Preliminary Efficacy of Aleeto in Patients With MultIple System Atrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 30 and 75 years, any sex
- Clinically confirmed or probable diagnosis of MSA-P
- Poor response to levodopa treatment
- Motor symptoms related to MSA started within 5 years before first visit
- Ability to walk at least 10 meters independently or with a walking aid
- Expected to survive at least 1 year as judged by the investigator
- Signed informed consent to participate in the study
You will not qualify if you...
- MRI showing other central nervous system diseases besides MSA
- Dementia indicated by low MMSE scores or prior dementia diagnosis
- MRI showing other major brain issues like bleeding, stroke, tumors, or infections
- Uncontrolled immune disorders or need for biological agent treatment
- Allergy to biological agents like proteins or cell products
- Vaccination within 1 month before enrollment
- Current or past cancer diagnosis or treatment
- History of epilepsy or use of anti-epileptic drugs
- Lumbar spine problems preventing safe lumbar puncture
- Abnormal blood clotting or coagulation disorders
- Contraindications to MRI such as claustrophobia or implanted metal devices
- Severe liver, kidney, or heart failure based on specific lab values and clinical classification
- Active hepatitis B or C infection or positive HIV test
- Alcohol or drug abuse or dependence within past 2 years
- Other psychiatric disorders including significant suicide risk
- Pregnant, breastfeeding, or planning pregnancy
- Participation in other investigational drug or device studies recently
- Inability to cooperate or complete follow-up visits
- Investigator judgment that patient is unsuitable for the trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
Research Team
W
Weiqi Chen, M.D.
CONTACT
L
Lei Guo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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