The Effect of Exosomes Derived From Human Induced Pluripotent Stem Cell (GD-iExo-003) in Acute Ischemic Stroke: an Exploratory Study.

XMEC-2023-004

This is a multicenter, randomized, double-blinded, placebo-controlled, dose-escalation trial. The objective of this study is evaluating safety and preliminary efficacy of intravenous exosomes derived from human induced pluripotent stem cell (GD-iExo-003) in acute ischemic stroke.

2024-05-27

2025-08-30

2025-08-30

Recruiting

Early phase I

29

Inclusion Criteria: * Clinical diagnosis of acute ischemic stroke * Age 18-70 years, inclusion of both genders * Modified Rankin Scale score before stroke of 0-1 * NIHSS score 6-20 at inclusion that did not change by ≥4 points from screening to baseline assessment. * Time of stroke onset is known and treatment can be started between day 1 and 7 of onset. * Confirmation of hemispheric cortical infarct with magnetic resonance imaging or computed tomography * Subjects who received intravenous thrombolysis or underwent mechanical reperfusion are eligible if they meet all other eligibility criteria. * Adequate hepatic and renal function: serum aspartate aminotransferase ≤2.5× upper limit of normal; serum alanine aminotransferase ≤2.5× upper limit of normal; blood urea nitrogen ≤1.25× upper limit of normal; serum creatinine ≤1.25× upper limit of normal * Adequate cardiac function. * Subjects or legal representative can sign the informed consent and must be willing and able to comply with all aspects of treatment and follow-up schedule. Exclusion Criteria: * Presence of intracranial hemorrhage on CT including hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage or hemorrhagic transformation, etc. * Presence of a lacunar or a brainstem infarct as the etiology of current symptoms. * Evidence of brain tumor or history of epilepsy or traumatic brain injury. * Subjects with present malignant disease. * Subjects with severe comorbidities including immunodeficiency or coagulation disorders. * Subjects with Alzheimer's disease, Parkinson's disease or other degenerative neurological disease. * Ongoing systemic infection, severe local infection or taking immunosuppressants. * Subjects with negative hepatitis B surface antibody (HBsAg) and positive hepatitis B core antibody (HBcAb), or HBsAg-positive virus carriers, positive hepatitis C antibody, positive syphilis antibody or HIV * Allergy to the study products. * Documented allergies * Participation in any clinical trial in the last 3 months * Inability or unwillingness to comply with the study schedule * Pregnancy, childbearing potential (unless it is certain that pregnancy is not possible), oe breast feeding * Other serious medical or psychiatric illness that is not adequately controlled * Other circumstances that the investigator considers inappropriate for participation in the trial.

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2024-05-29