Actively Recruiting
The Effect of GD-iExo-003 in Acute Ischemic Stroke
Led by Xuanwu Hospital, Beijing · Updated on 2025-12-04
29
Participants Needed
1
Research Sites
94 weeks
Total Duration
On this page
Sponsors
X
Xuanwu Hospital, Beijing
Lead Sponsor
G
Guidon Pharmaceutics Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of GD-iExo-003 in Acute Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of acute ischemic stroke
- Age 18-70 years, including both genders
- Modified Rankin Scale score of 0-1 before stroke
- NIH Stroke Scale (NIHSS) score between 6 and 20 at study entry without a change of 4 points or more from screening to baseline
- Known time of stroke onset with treatment possible between day 1 and day 7 after onset
- Confirmation of hemispheric cortical infarct by MRI or CT scan
- Subjects who received intravenous thrombolysis or mechanical reperfusion are eligible if other criteria are met
- Adequate liver and kidney function based on specific blood test limits
- Adequate heart function
- Ability to provide informed consent or have a legal representative consent and willingness to follow treatment and follow-up
You will not qualify if you...
- Presence of any intracranial hemorrhage including hemorrhagic stroke, epidural or subdural hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation
- Lacunar or brainstem infarct causing current symptoms
- Evidence or history of brain tumor, epilepsy, or traumatic brain injury
- Current malignant disease
- Severe comorbidities such as immunodeficiency or bleeding disorders
- Alzheimer's disease, Parkinson's disease, or other degenerative neurological diseases
- Ongoing severe infection or use of immunosuppressant drugs
- Positive tests for hepatitis B or C, syphilis, or HIV
- Allergy to study products or documented allergies
- Participation in another clinical trial within the last 3 months
- Inability or unwillingness to comply with study procedures
- Pregnancy, breastfeeding, or potential for pregnancy
- Other serious uncontrolled medical or psychiatric conditions
- Any other reason the investigator considers inappropriate for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Xuanwu Hospital, Capital Medical University
Beijing, China, 100053
Actively Recruiting
Research Team
J
Junwei Hao, MD; PhD
CONTACT
G
Gaoting Ma, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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