Testing B2065 for safety and early effectiveness in acute ischemic stroke

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.

This will test a single IV infusion of B2065 versus placebo in adults 18–75 who have an acute ischemic stroke and can be treated within 36 hours of symptom onset.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tasly Pharmaceutical Group Co., Ltd (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT07371624 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled Phase I/IIa study gives a single intravenous dose of B2065 (an allogeneic adipose-derived mesenchymal stromal cell product) or placebo to adults with acute ischemic stroke. Phase I uses dose escalation with sentinel dosing to identify dose-limiting toxicities within 28 days and to select one or two dose levels. Phase IIa expands the selected dose level(s) and randomizes participants 2:1 (B2065:placebo) to gather preliminary efficacy and additional safety data. Safety, tolerability, and functional outcomes are followed through 24 months.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 with imaging-confirmed acute ischemic stroke, NIHSS 8–20, able to receive the infusion within 36 hours of symptom onset, and who have not received thrombolysis or mechanical thrombectomy.

Not a fit: Patients with intracranial hemorrhage, pre-stroke disability (mRS ≥2), prior thrombolysis or thrombectomy, presentation beyond 36 hours, or NIHSS scores outside 8–20 are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, B2065 might improve recovery and reduce disability after acute ischemic stroke by promoting tissue repair and functional recovery.

How similar studies have performed: Early-phase trials of mesenchymal stromal cells in stroke have generally shown acceptable safety and occasional signals of benefit, but no large randomized trials have yet proven clear clinical efficacy, so the approach remains experimental.

Eligibility criteria

Inclusion Criteria

1. Aged 18 to 75 years (inclusive of the boundary values), with no restriction on sex.
2. Patients with ischemic stroke confirmed by imaging examinations (CT/MRI).
3. 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).
4. NIHSS score at screening is 8 to 20.
5. The patient or legally authorized representative is willing to participate in this trial and agrees to sign the informed consent form.

Exclusion Criteria

1. Patients who have received intravenous thrombolysis and/or mechanical thrombectomy prior to dosing.
2. Modified Rankin Scale (mRS) score ≥2 before stroke onset.
3. 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.
4. Patients who are unable to undergo CT and/or MRI examinations.
5. Patients with decreased level of consciousness (NIHSS item 1a score ≥2).
6. Patients who may have major neurologic or psychiatric disorders that seriously interfere with the participant's compliance with trial assessments.
7. Body temperature \>38°C prior to dosing, and the investigator assesses that there is a risk of infection.
8. 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.
9. Patients with current or prior severe diseases of other organ systems, including but not limited to:

   1. Patients with severe heart failure (NYHA Class III or IV) and/or severe respiratory failure;
   2. Patients with renal disease with estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m²;
   3. Advanced liver disease, such as hepatitis or liver cirrhosis;
   4. 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);
   5. Patients with hypertension not controlled after taking therapeutic medications, with systolic blood pressure ≥185 mmHg and/or diastolic blood pressure ≥110 mmHg;
   6. Blood glucose \<2.8 mmol/L (50 mg/dL) or \>22.2 mmol/L (400 mg/dL).
10. Screening laboratory tests meeting any of the following criteria:

    1. Serum alanine aminotransferase (ALT) ≥3× upper limit of normal (ULN);
    2. Serum aspartate aminotransferase (AST) ≥3× ULN;
    3. Serum creatinine (Cr) ≥2× ULN;
    4. Absolute neutrophil count (ANC) \<1.5×10\^9/L;
    5. Platelet count (PLT) \<100×10\^9/L;
    6. Hemoglobin (Hgb) \<90 g/L;
    7. International normalized ratio (INR) \>1.7 or activated partial thromboplastin time (APTT) \>1.25× ULN.
11. Patients with malignant tumors or other diseases with an expected survival of less than 2 years.
12. Patients with other acquired or congenital immunodeficiency diseases, or those currently using immunosuppressants.
13. Patients who, upon screening inquiry, have alcohol dependence or a history of drug abuse.
14. 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.
15. Patients who participated in any other clinical trial within 1 month prior to screening.
16. Patients who are allergic to any component of the investigational product.
17. Patients deemed by the investigator to be unsuitable for participation in this trial.

Where this trial is running

Beijing

• Beijing Tiantan Hospital, Capital Medical University — Beijing, China (Recruiting)

Conditions Acute Ischemic Stroke