A Phase 1b Study to Assess the Safety and Tolerability of AB126 Neural Exosomes in Patients With Moderate to Severe Acute Ischemic Stroke
Public ClinicalTrials.gov record NCT07813130. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Adaptive, Dose Escalation Study to Assess the Safety and Tolerability of AB126 Neural Exosomes Intravenous Injection in Patients With Moderate to Severe Acute Ischemic Stroke Following Endovascular Therapy and Limited Neurological Improvement
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT07813130
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 20 participants
Conditions and interventions
Conditions
Interventions
- AB126 Neural Exosomes Intravenous Injection Biological
- AB126 Placebo Other
Biological · Other
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2026
- Primary completion
- Sep 30, 2028
- Completion
- Mar 31, 2029
- Last update posted
- Sep 9, 2026
2026 – 2029
United States locations
- U.S. sites
- 3
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Memorial Hermann - Memorial City Medical Center | Houston | Texas | 77024 | — |
| Memorial Hermann-Texas Medical Center | Houston | Texas | 77030 | — |
| Memorial Hermann- Southwest Hospital | Houston | Texas | 77074 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07813130, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 9, 2026 · Synced Sep 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07813130 live on ClinicalTrials.gov.