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RECRUITINGPHASE1/PHASE2

A Study of the Safety, Tolerability and Preliminary Efficacy of B2065 in Patients With 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.

NCT07371624•Tasly Pharmaceutical Group Co., Ltd

View on ClinicalTrials.gov

Summary

This Phase I/IIa, randomized, double-blind, placebo-controlled study evaluates the safety, tolerability, and preliminary efficacy of B2065, an allogeneic adipose-derived mesenchymal stromal cell (AD-MSC) injection, in patients with acute ischemic stroke. Participants receive a single intravenous infusion of B2065 or placebo within 36 hours of stroke symptom onset. Phase I uses dose escalation with sentinel dosing to assess dose-limiting toxicities within 28 days and to inform dose selection. Phase IIa expands 1-2 selected dose level(s) and randomizes participants 2:1 (B2065:placebo). Safety and functional outcomes are assessed through 24 months.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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;
+20 more criteria

Locations (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

Key Dates

Start Date

December 31, 2025

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

January 28, 2026

Enrollment

ESTIMATED participants

Conditions

Acute Ischemic Stroke

Interventions

B2065

DRUG

Placebo

DRUG

Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

NCT07253181

Acute Ischemic StrokeLarge Vessel Occlusion+1 more

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RECRUITINGPHASE2/PHASE3

Optimizing Reperfusion to Improve Outcomes and Neurologic Function

NCT06990867

Acute Ischemic Stroke

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of the Safety, Tolerability and Preliminary Efficacy of B2065 in Patients With Acute Ischemic Stroke.

Inclusion Criteria

Exclusion Criteria

Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

Optimizing Reperfusion to Improve Outcomes and Neurologic Function

Prospective Randomized Observer Blinded Single Center Study Comparing 90-day Functional Outcome in Patients Who Received Intravenous Propofol Infusion Versus Inhalational Sevoflurane for General Anesthesia During Mechanical Thrombectomy in Patients Who Suffered From Acute Ischemic Stroke

Brain, Blood And Clot or Tissue Registry And Collaboration

Radiohistological Correlation of Thrombohemorrhagic Remodeling in the Acute Phase of Ischemic Stroke Managed by Decompressive Hemicraniectomy

Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke