A Study of B2065 in Patients With Acute Ischemic Stroke
ConditionAcute Ischemic Stroke
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTasly Pharmaceutical Group Co., Ltd
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
Patients who have received intravenous thrombolysis and/or mechanical thrombectomy prior to dosing.
Modified Rankin Scale (mRS) score ≥2 before stroke onset.
Patients who currently have intracranial hemorrhagic diseases (e.g., intracerebral hemorrhage, epidural hematoma, subarachnoid hemorrhage, etc.), or who have brain tumors, cerebrovascular malformations, multiple sclerosis, a history of severe traumatic brain injury, encephalitis, or other conditions causing stroke-like symptoms.
Patients who are unable to undergo CT and/or MRI examinations.
Trial design
Treatments tested in this trial
- B2065
- Placebo
Treatment groups
54 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov