The Effect of GD-iExo-003 in Acute Ischemic Stroke

• Status: Recruiting
• Trial end date: 2025-08-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xuanwu Hospital, Beijing
• Collaborator: Guidon Pharmaceutics Ltd.

Criteria

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.