A Phase I/IIa Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Allogeneic Adipose-Derived Mesenchymal Stromal Cell Injection (B2065) in Participants With Acute Ischemic Stroke.
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
• Aged 18 to 75 years (inclusive of the boundary values), with no restriction on sex.
• Patients with ischemic stroke confirmed by imaging examinations (CT/MRI).
• Time from onset of stroke symptoms to administration of the investigational product ≤36 hours; for wake-up stroke, the time of onset is defined as the last-known-well time (the last time the patient was observed to be normal).
• NIHSS score at screening is 8 to 20.
• The patient or legally authorized representative is willing to participate in this trial and agrees to sign the informed consent form.