A Study of B2065 in Patients With Acute Ischemic Stroke (NCT07371624) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of B2065 in Patients With Acute Ischemic Stroke
China54 participantsStarted 2025-12-31
Plain-language 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Dose-Limiting Toxicities (DLTs) [Safety]
Timeframe: Within 28 days after dosing.
2
Incidence of Infusion-Related Reactions [Safety]
Timeframe: Within 7 days, 14 days, and 28 days.
3
All-Cause Mortality Rate [Safety]
Timeframe: Within 14 days,12 months, and 24 months.
4
Incidence of abnormal imaging findings indicative of tumorigenicity [Safety]
Timeframe: Month 6 and month 24.
5
Change from baseline in serum tumor marker levels [Safety]
Timeframe: Change from baseline at Month 6 and Month 24.
6
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) [Safety]
. 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.
. Patients with decreased level of consciousness (NIHSS item 1a score ≥2).
. Patients who may have major neurologic or psychiatric disorders that seriously interfere with the participant's compliance with trial assessments.
. Body temperature \>38°C prior to dosing, and the investigator assesses that there is a risk of infection.
. Patients with uncontrollable active infection; or patients who have received systemic anti-infective therapy within 7 days prior to dosing and, in the investigator's judgment, may be likely to convert to uncontrollable active infection in the short term.