Status:
RECRUITING
The Effect of GD-iExo-003 in Acute Ischemic Stroke
Lead Sponsor:
Xuanwu Hospital, Beijing
Collaborating Sponsors:
Guidon Pharmaceutics Ltd.
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
This is a multicenter, randomized, double-blinded, placebo-controlled, dose-escalation trial. This study will consist of 2 parts, with part 1 being a dose-escalation study and part 2 being an expanded...
Eligibility Criteria
Inclusion
- 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
- 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 positive 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.
Key Trial Info
Start Date :
June 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT06138210
Start Date
June 5 2024
End Date
March 30 2026
Last Update
December 4 2025
Active Locations (1)
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1
Xuanwu Hospital, Capital Medical University
Beijing, China, 100053