Cerebral ischemic stroke
Conditions
Interventions
Experimental Group:ALT001 intravenous infusion at 130 µg/day (one 130-µg vial reconstituted in 100 mL 0.9% sodium chloride injection), administered daily for 2 weeks followed by a 2-week rest period (
total 14 doses per cycle). Repeated for 3 cycles (total 12 weeks).
Control Group:Placebo identical to ALT001 in formulation, appearance, and olfactory properties, administered via the same regimen and duration as the experimental group.
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: Study Subjects: Ischemic stroke patients in the recovery phase, 180 days to 5 years post-stroke. Inclusion Criteria: 1. Age between 30 and 80 years (inclusive). 2. Imaging-confirmed unilateral ischemic stroke sequelae, with the most recent episode occurring >= 180 days but <= 5 years prior. 3. Unilateral limb weakness, with a Fugl-Meyer Upper Extremity Score (FM-UE) <44 (maximum score: 66). 4. Modified Ashworth Scale score <= 2. 5. Provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1. Posterior circulation infarction. 2. Baseline head CT or MRI demonstrating malformations, tumors, abscesses, or other significant non-vascular brain diseases (e.g., neurodegenerative disorders such as multiple sclerosis, dementia, or Parkinson's disease). 3. Isolated or pure sensory symptoms (e.g., numbness), isolated visual changes, or isolated dizziness/vertigo, without evidence of acute infarction on baseline head CT or MRI. 4. Chronic, severe, or unstable neurological disorders not attributable to stroke. 5. History of recurrent seizure episodes or epilepsy. 6. History of infectious diseases (positive HIV test or history thereof; positive HCV antibody test or history thereof; HBsAg positivity and/or serum HBV DNA positivity, or serum HBV DNA >2×10^8 IU/mL). 7. Severe hepatic or renal dysfunction (severe hepatic dysfunction defined as ALT >= 3×ULN or AST >= 3×ULN; severe renal dysfunction defined as SCr >= 1.5×ULN); severe heart failure (New York Heart Association Class III–IV). 8. Current use of dual antiplatelet therapy or anticoagulants. 9. History of coagulation disorders or systemic bleeding; history of thrombocytopenia or neutropenia; history of drug-induced hematological or hepatic abnormalities; leukopenia (35 kg/m^2. 12. Severe organic diseases, such as malignancies, with an expected survival of <3 months. 13. Pregnancy, lactation, or women of childbearing potential who are planning or may become pregnant during the trial period. 14. Inability to understand and/or follow study procedures due to psychiatric, cognitive, or emotional disorders, or aphasia (severity grade 0). 15. Comorbid history of alcohol or drug abuse. 16. Known history of allergy to biological agents such as proteins or cellular products. 17. Administration of any vaccine within 28 days prior to enrollment. 18. Use of other investigational drugs within 30 days or 5 half-lives (whichever is longer). 19. Inability to comply with follow-up due to geographical or other reasons. 20. Concurrent participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Motor function assessment indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| General demographic indicators and clinical data;Vital signs and physical examination;Neurological recovery assessment indicators;Independent living ability assessment indicators;Muscle tone examination;Cognitive function assessment indicators;Laboratory tests and auxiliary examinations data collection;Other information collection; | — |
Countries
China
Contacts
Public ContactYilong Wang
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed