The goal of this clinical trial is to learn if AB126, an investigational treatment made from neural exosomes, is safe and well tolerated when given to adults with moderate to severe acute ischemic stroke (AIS) who have undergone endovascular thrombectomy (EVT) but have had limited neurological improvement after the procedure. The study will also evaluate different doses of AB126 to help determine the highest dose that can be given safely. The main questions it aims to answer are: 1. Is AB126 safe and well tolerated when given to participants with AIS following EVT? 2. What dose of AB126 can be given safely? 3. Does treatment with AB126 provide preliminary evidence of improved neurological recovery following stroke? Researchers will compare participants who receive AB126 with participants who receive placebo to evaluate the safety and tolerability of AB126 and to collect preliminary information about recovery following stroke. Participants will: 1. Be randomly assigned to receive either AB126 or placebo. Neither participants nor the study team will know which treatment is assigned. 2. Receive 3 intravenous (IV) doses of AB126 or placebo. The first dose will be given as soon as possible after EVT, but no later than 6 hours after blood flow has been restored. The second and third doses will be given approximately 24 and 48 hours after EVT. 3. Undergo medical examinations, laboratory tests, neurological assessments, and brain imaging during the study. 4. Remain under observation at a comprehensive stroke center until hospital discharge. 5. Complete follow-up assessments by telephone and in person for approximately 1 year after treatment, including assessments at approximately 10, 30, 90, 180, 270, and 360 days after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
Three (3) intravenous injections of the active ingredient will be administered on Day 0, 1, and 2 after stroke.
AB126 Placebo, comprised of non-active ingredients, will be administered on Day 0, 1, and 2 after stroke.
Memorial Hermann - Memorial City Medical Center
Houston, Texas, United States
Memorial Hermann-Texas Medical Center
Houston, Texas, United States
Memorial Hermann- Southwest Hospital
Houston, Texas, United States
Treatment-emergent adverse events
The primary objective of this study is to evaluate the safety and tolerability of escalating doses of AB126 in patients with moderate to severe AIS who have undergone EVT and demonstrate limited neurological improvement post-procedure. The primary safety study endpoints will be assessed through Day 90. These study endpoints will also be assessed through Day 360 or end of study.
Time frame: Through Day 90
Changes in physical and clinical examination findings
Time frame: Through Day 90
Rates of death
Time frame: Through Day 90
Recurrent stroke
Time frame: Through Day 90
Symptomatic intracranial hemorrhage (sICH)
Time frame: Through Day 90
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