B2065 Stem Cell Injection for Adults With Acute Ischemic Stroke
Tests B2065, a stem cell injection, against placebo in adults with acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: A Study of B2065 in Patients With Acute Ischemic Stroke
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 who had an acute ischemic stroke confirmed by CT or MRI. Treatment must start within 36 hours of the first symptoms.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Ischemic stroke confirmed by CT or MRI, with an NIHSS score of 8 to 20. The time from first symptoms to the study treatment must be 36 hours or less. For a stroke noticed on waking, the time counts from when the person was last seen well.
- Earlier treatment
- People who had intravenous thrombolysis or mechanical thrombectomy before the study dose cannot join.
Main reasons for not taking part
- Bleeding in the brain, brain tumor or other conditions that cause stroke-like symptoms
- Modified Rankin Scale score of 2 or more before the stroke
- Uncontrolled active infection, or hepatitis B, hepatitis C, syphilis or HIV antibody positive
- Severe heart, lung, kidney or liver disease
- Pregnant or breastfeeding women
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07371624, who can take part
Where in China
- Beijing Tiantan Hospital,Capital Medical UniversityBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tasly Pharmaceutical Group Co., Ltd
- Trial code
- NCT07371624
- Record updated
- 13 August 2026
- Original description
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:Read full original descriptionShow less
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
Inclusion: 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: Patients who have received intravenous thrombolysis and/or mechanical thrombectomy prior to dosing; 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; Patients with other acquired or congenital immunodeficiency diseases, or those currently using immunosuppressants; Patients who participated in any other clinical trial within 1 month prior to screening; Patients who are allergic to any component of the investigational product; 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 may have major neurologic or psychiatric disorders that seriously interfere with the participant's compliance with trial assessments; Patients with malignant tumors or other diseases with an expected survival of less than 2 years; Patients who, upon screening inquiry, have alcohol dependence or a history of drug abuse; Patients with current or prior severe diseases of other organ systems, including but not limited to:; Patients with severe heart failure (NYHA Class III or IV) and/or severe respiratory failure; Patients with renal disease with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m²; Advanced liver disease, such as hepatitis or liver cirrhosis; Patients positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg); patients positive for hepatitis B e antibody (HBeAb) and/or hepatitis B core antibody (HBcAb) with quantitative HBV-DNA above the upper limit of normal; patients with any of the following test results positive: hepatitis C virus antibody (HCV-Ab), Treponema pallidum antibody (TP-Ab), or human immunodeficiency virus antibody (HIV-Ab); Patients with hypertension not controlled after taking therapeutic medications, with systolic blood pressure ≥185 mmHg and/or diastolic blood pressure ≥110 mmHg; Blood glucose <2.8 mmol/L (50 mg/dL) or >22.2 mmol/L (400 mg/dL); Screening laboratory tests meeting any of the following criteria:; Serum alanine aminotransferase (ALT) ≥3× upper limit of normal (ULN); Serum aspartate aminotransferase (AST) ≥3× ULN; Serum creatinine (Cr) ≥2× ULN; Absolute neutrophil count (ANC) <1.5×10\^9/L; Platelet count (PLT) <100×10\^9/L; Hemoglobin (Hgb) <90 g/L; International normalized ratio (INR) >1.7 or activated partial thromboplastin time (APTT) >1.25× ULN; Patients who are unable to undergo CT and/or MRI examinations; Patients with decreased level of consciousness (NIHSS item 1a score ≥2); Pregnant or breastfeeding women; or those who plan to conceive, donate sperm, or donate oocytes during the trial and/or are unwilling to take effective contraception measures; Patients deemed by the investigator to be unsuitable for participation in this trial.