Actively Recruiting
A Study of the Safety, Tolerability and Preliminary Efficacy of B2065 in Patients With Acute Ischemic Stroke.
Led by Tasly Pharmaceutical Group Co., Ltd · Updated on 2026-01-28
54
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of the Safety, Tolerability and Preliminary Efficacy of B2065 in Patients With Acute Ischemic Stroke.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- 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.
You will not qualify if you...
- 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 or brain tumors, cerebrovascular malformations, multiple sclerosis, history of severe traumatic brain injury, encephalitis, or other stroke-like conditions.
- Patients unable to undergo CT and/or MRI examinations.
- Patients with decreased level of consciousness (NIHSS item 1a score 2).
- Patients with major neurologic or psychiatric disorders interfering with trial compliance.
- Body temperature >38 0C prior to dosing with risk of infection.
- Patients with uncontrollable active infection or recent systemic anti-infective therapy within 7 days prior to dosing.
- Patients with severe diseases of other organ systems including severe heart failure, severe respiratory failure, renal disease with eGFR <30 mL/min/1.73 m8, advanced liver disease, positive hepatitis or HIV markers, uncontrolled hypertension, or abnormal blood glucose levels.
- Screening lab tests showing elevated liver enzymes, creatinine, low neutrophil count, low platelet count, low hemoglobin, or abnormal coagulation measures.
- Patients with malignant tumors or other diseases with expected survival <2 years.
- Patients with immunodeficiency or using immunosuppressants.
- Patients with alcohol dependence or drug abuse history.
- Pregnant or breastfeeding women or those planning conception or donation without effective contraception.
- Participation in another clinical trial within 1 month prior to screening.
- Allergy to any component of the investigational product.
- Patients deemed unsuitable by investigator for participation.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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