[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574934":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":32,"locations":42,"responsibleParty":61,"collaborators":18,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":18,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":45,"whyStopped":18,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Intrathecal administration combined with intravenous administration of Aleeto of Aleeto was given to each MSA patient in the intervention group, with intrathecal administration on days 1, 31 and 61 and intravenous administration on days 2 to 14, 32 to 44±3 and 62 to 74±5, and treatment was given once a day.\n\nintrathecal administration: 8 mL sodium chloride injection + Aleeto (130 μg\u002Fbranch) for intrathecal administration, which was completed in about 5 minutes; intravenous administration: Aleeto (130 μg\u002Fbranch) was dissolved in 100 ml sodium chloride injection, which was completed in about 30-40 minutes. After completion of the above treatments and 90±7 days of follow-up, all subjects entered the OLE study phase. During this period, all participants were given the option of continuing to receive 3 phases (on Days 91 to 104±7, Days 121 to 134±7, and Days 151 to 164±7) of intravenous Aleeto administration (14 consecutive days of Aleeto 130 μg qd i.v. in each phase).",[13],"Drug: Aleeto",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Each MSA patient in the blank control group received only basic treatment with no trial-related treatment.\n\nAfter completion of the above treatments and 90±7 days of follow-up, all subjects entered the OLE study phase. During this period, all participants were given the option of continuing to receive 3 phases (on Days 91 to 104±7, Days 121 to 134±7, and Days 151 to 164±7) of intravenous Aleeto administration (14 consecutive days of Aleeto 130 μg qd i.v. in each phase).",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Aleeto","\"Aleeto\" is a nerve repair protein developed by Darwin Start (Beijing) Biopharmaceutical Co., Ltd. It is a group of specific microenvironmental protein polymers secreted under the emergency conditions of stem cells. It has the advantages of selective assembly, targeted delivery, efficient repair of damaged tissues, high safety, chemical stability, easy storage, etc., and has a powerful neural repair function. According to the groups, patients would be treated with Aleeto via intrathecal injection or intravenous injection.",[9],[26,30],{"name":27,"affiliation":28,"role":29},"Yilong Wang, M.D.","Beijing Tiantan Hospital, Capital Medical University, Beijing, China","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":28,"role":29},"Tao Feng, M.D.",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},"Weiqi Chen, M.D.","CONTACT","8615652813380","weiqichen@aliyun.com",{"name":39,"role":35,"phone":40,"phoneExt":18,"email":41},"Lei Guo","8619801237597","guolei53@aliyun.com",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Beijing Tiantan Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","100070","China","CN",{"type":52,"coordinates":53},"Point",[54,55],116.39723,39.9075,{"lat":55,"lon":54},[58],{"name":27,"role":35,"phone":59,"phoneExt":18,"email":60},"010-59976247","yilong528@aliyun.com",{"type":29,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"yilong Wang","Vice President of Beijing Tiantan Hospital","100574934","early-phase-1-the-study-of-safety-and-preliminary-efficacy-of-aleeto-in-patients-with-multiple-system-atrophy-100574934",false,"NCT06765733","The Study of Safety and Preliminary Efficacy of Aleeto in Patients With MultIple System Atrophy","SPRITE","Inclusion Criteria:\n\n1.30 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.\n\nExclusion Criteria:\n\n1. Head MRI at screening showing evidence of other CNS lesions consistent with a diagnosis of neurodegenerative disease other than MSA;\n2. 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;\n3. 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 \\\u003C1 cm need not be excluded);\n4. Presence of immune disorders that are inadequately controlled or require treatment with biological agents;\n5. Known history of allergy to biological agents such as proteins and cell products;\n6. Patients who have received any vaccination within 1 month;\n7. Patients with pre-existing, clearly diagnosed malignant tumor or being treated with anti-tumor drugs;\n8. Patients with a history of clearly diagnosed epilepsy or taking antiepileptic drugs;\n9. Presence of lumbar spine disease and deformity or other contraindications to lumbar puncture;\n10. Patients with abnormal coagulation function prior to enrolment (e.g., platelet count \\\u003C100 × 10E9\u002FL; prothrombin time \\[PT\\] \\>3 s), previous diagnosis of coagulation disorders such as hemophilia, and patients currently receiving more than two types of antiplatelet medication;\n11. Contraindications to MRI (e.g. claustrophobia, internal placement of pacemakers or paramagnetic metals, etc.);\n12. 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\\\u003C40mL\u002Fmin\u002F1.73m2; severe cardiac insufficiency refers to NYHA class 3-4);\n13. Hepatitis B active infection (hepatitis B surface antigen positive and\u002For serum HBV DNA positive or serum HBV DNA \\> 2 × 10E8 IU\u002Fml;\n14. Hepatitis C virus antibody positive or history of positive test;\n15. Positive HIV test or history of positive test;\n16. Patients with a combined history of alcohol or drug abuse or alcohol or drug dependence within 2 years;\n17. Other psychiatric disorders diagnosed according to DSM-V diagnostic criteria, or significant suicide intent;\n18. Patients who are pregnant, breast-feeding, or who are likely to become pregnant and plan to become pregnant;\n19. 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;\n20. Unable to be cooperative and complete the follow-up due to other reasons.\n21. Patients who, in the opinion of the investigator, are not suitable for participation in this trial.","ALL","30 Years","75 Years",{"count":75,"type":76},20,"ESTIMATED","INTERVENTIONAL",[79],"EARLY_PHASE1","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).",[82,83],"Multiple System Atrophy - Parkinsonian Subtype (MSA-P)","Multiple System Atrophy, MSA",[85,86,87,88],"Multiple System Atrophy","Treatment","Exosomes","Neurorepair","2025-08-30",{"date":91,"type":92},"2025-09-03","ACTUAL",{"date":94,"type":92},"2025-05-31",{"date":96,"type":76},"2026-12-31",{"name":5,"class":6},1]