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A Study of B2065 in Patients With Acute Ischemic Stroke

NCT07371624 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-08-13

No results posted yet for this study

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

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

B2065

Administered by intravenous infusion.

DRUG

Placebo

Administered by intravenous infusion.

Sponsors & Collaborators

  • Tasly Pharmaceutical Group Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07371624 on ClinicalTrials.gov