NCT06765733 The Study of Safety and Preliminary Efficacy of Aleeto in Patients With MultIple System Atrophy

Eligibility & Interventions

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 20 participants in total. It began in 2025-05-31 with a primary completion date of 2026-09-30.

Brief Summary

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).

Eligibility Criteria

Inclusion Criteria: 1.30 years ≤ 75 years of age, regardless of sex; 2.Clinically confirmed or clinically probable MSA-P; 3.Poor response to levodopa; 4.MSA-related motor symptom onset ≤5 years at first visit; 5.Walking ≥10 meters independently or with a walking aid; 6.Expected survival of ≥1 year, as determined by the investigator; 7.Signed informed consent. Exclusion Criteria: 1. Head MRI at screening showing evidence of other CNS lesions consistent with a diagnosis of neurodegenerative disease other than MSA; 2. Patients with MMSE scores indicative of dementia prior to enrolment (≤17 points for illiterate individuals, ≤20 points for individuals with elementary school education, ≤24 points for individuals with junior high school education or higher) or those with a prior confirmed diagnosis of dementia; 3. Head MRI at screening showing other significant pathological findings including but not limited to: cerebral hemorrhage, acute phase of cerebral infarction, aneurysm, vascular malformation, infectious lesion, brain tumor or other space-occupying lesion (meningiomas or arachnoid cysts with a maximum diameter of \<1 cm need not be excluded); 4. Presence of immune disorders that are inadequately controlled or require treatment with biological agents; 5. Known history of allergy to biological agents such as proteins and cell products; 6. Patients who have received any vaccination within 1 month; 7. Patients with pre-existing, clearly diagnosed malignant tumor or being treated with anti-tumor drugs; 8. Patients with a history of clearly diagnosed epilepsy or taking antiepileptic drugs; 9. Presence of lumbar spine disease and deformity or other contraindications to lumbar puncture; 10. Patients with abnormal coagulation function prior to enrolment (e.g., platelet count \<100 × 10E9/L; prothrombin time \[PT\] \>3 s), previous diagnosis of coagulation disorders such as hemophilia, and patients currently receiving more than two types of antiplatelet medication; 11. Contraindications to MRI (e.g. claustrophobia, internal placement of pacemakers or paramagnetic metals, etc.); 12. With severe hepatic insufficiency, renal insufficiency or severe cardiac insufficiency (severe hepatic insufficiency refers to ALT value≥2.0 times the upper limit of normal value or AST value≥2.0 times the upper limit of normal value; severe renal insufficiency refers to CRE≥1.5 times the upper limit of normal value or eGFR\<40mL/min/1.73m2; severe cardiac insufficiency refers to NYHA class 3-4); 13. Hepatitis B active infection (hepatitis B surface antigen positive and/or serum HBV DNA positive or serum HBV DNA \> 2 × 10E8 IU/ml; 14. Hepatitis C virus antibody positive or history of positive test; 15. Positive HIV test or history of positive test; 16. Patients with a combined history of alcohol or drug abuse or alcohol or drug dependence within 2 years; 17. Other psychiatric disorders diagnosed according to DSM-V diagnostic criteria, or significant suicide intent; 18. Patients who are pregnant, breast-feeding, or who are likely to become pregnant and plan to become pregnant; 19. Patients who are participating in other interventional studies or using other investigational biological agents, drugs, or devices, and patients who have used other experimental drugs within 1 month or within 5 drug half-lives; 20. Unable to be cooperative and complete the follow-up due to other reasons. 21. Patients who, in the opinion of the investigator, are not suitable for participation in this trial.

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