Clinical Trial

A Study of B2065 in Patients With Acute Ischemic Stroke

Recruiting Phase 1/2
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Summary
The goal of this clinical trial is to evaluate the safety of B2065, an allogeneic adipose-derived mesenchymal stromal cell (AD-MSC) injection. It will also assess whether B2065 works to treat acute ischemic stroke. The main questions it aims to answer are: At what dose range is the drug safe for participants? Which dose shows preliminary efficacy? Researchers will compare B2065 to a placebo (a look-alike substance that contains no drug) to see if B2065 works to treat acute ischemic stroke. Participants will: Receive a single dose of B2065 during hospitalization Visit the hospital as scheduled for safety and efficacy assessments
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-08-14
Trial Details
NCT Number NCT07371624
Lead Sponsor Tasly Pharmaceutical Group Co., Ltd
Conditions Acute Ischemic Stroke
Enrollment 54 participants
Start Date 2025-12-31
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-13