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
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates multiple system atrophy (MSA), a rare and progressive neurodegenerative disorder that affects autonomic functions, movement, and coordination. MSA primarily impacts adults with an average onset age around 56 years and leads to severe disability within a few years. The study aims to evaluate the safety, tolerability, and early signs of effectiveness of Aleeto, a nerve repair protein derived from stem cell exosomes, in patients with MSA-parkinsonian type (MSA-P). Participants are randomly assigned to either receive Aleeto through a combination of intrathecal and intravenous administrations or to a control group receiving standard basic treatment without trial-related medication. Aleeto is given intrathecally on days 1, 31, and 61, and intravenously once daily during specific periods. After an initial 90-day treatment and follow-up phase, all participants may choose to continue Aleeto in an open-label extension phase with three additional intravenous treatment periods. During the study, participants undergo comprehensive assessments including vital signs, neurological exams, laboratory tests, imaging such as MRI and bladder ultrasound, and multiple neurological and quality-of-life scales. Cerebrospinal fluid is also collected at various stages. Researchers closely monitor safety through adverse event reporting and evaluate changes in motor symptoms and autonomic function. Follow-up visits continue up to one year after randomization to assess ongoing effects and safety.
CONDITIONS
Brief 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 multiple system atrophy parkinsonian type (MSA-P)
- Poor response to levodopa medication
- Motor symptoms related to MSA started within the last 5 years
- Able 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 form
You will not qualify if you...
- MRI showing other brain lesions or neurodegenerative diseases besides MSA
- Dementia indicated by Mini-Mental State Examination (MMSE) scores below defined thresholds or prior dementia diagnosis
- MRI showing significant brain pathology such as hemorrhage, infarction, tumors, or vascular malformations
- Uncontrolled immune disorders or treatment with biological agents
- Allergy to biological agents like proteins or cell products
- Vaccination within 1 month before the study
- History of malignant tumors or current cancer treatment
- History of epilepsy or use of antiepileptic drugs
- Lumbar spine disease or deformities contraindicating lumbar puncture
- Abnormal blood clotting or use of multiple antiplatelet medications
- Contraindications to MRI such as claustrophobia or implanted metal devices
- Severe liver, kidney, or heart failure
- Active hepatitis B or C infection or positive HIV test
- History of alcohol or drug abuse within 2 years
- Diagnosed psychiatric disorders or significant suicide risk
- Pregnant, breastfeeding, or planning pregnancy
- Participation in other interventional studies or recent use of experimental drugs
- Inability to cooperate or complete follow-up
- Investigator judgment deeming unsuitability for the trial
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 90 days
Participants receive Aleeto treatment via intrathecal and intravenous injections over three treatment periods, with daily dosing during specified days in each period.
Multiple visits including intrathecal injections on Days 1, 31, and 61, and daily intravenous infusions during Days 2-14, 32-44, and 62-74
Duration - Approximately 75 days
Participants have the option to continue Aleeto treatment with three additional phases of intravenous administration, each lasting 14 consecutive days.
Three treatment phases on Days 91-104, 121-134, and 151-164 with daily intravenous infusions
Duration - Up to 360 days post-randomization
Participants undergo comprehensive physical exams, laboratory tests, imaging, neurological assessments, and adverse event monitoring at multiple time points after treatment periods.
Visits at Days 90, 180, and 360 with additional visits as needed for new symptoms
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.
L
Lei Guo
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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