Actively Recruiting
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
Led by Tasly Pharmaceutical Group Co., Ltd · Updated on 2026-01-28
54
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and early effects of B2065, an allogeneic adipose-derived mesenchymal stromal cell injection, in adults with acute ischemic stroke. This Phase I/IIa randomized, double-blind, placebo-controlled study enrolls patients within 36 hours of stroke symptom onset. Phase I involves dose escalation to identify dose-limiting toxicities within 28 days and select appropriate doses. Phase IIa expands selected dose levels and randomizes participants in a 2:1 ratio to B2065 or placebo. Safety and functional outcomes are monitored for up to 24 months. Participants receive a single intravenous infusion of B2065 or placebo formulated in 1% human serum albumin and sodium chloride. Phase I tests three doses: 5.0×10^7 cells, 1.5×10^8 cells, and 4.5×10^8 cells. Phase IIa includes one or two dose cohorts from Phase I with randomization to B2065 or placebo. Placebo matches the infusion volume and bags. The study uses a double-blind design to compare the treatments. During the study, participants will undergo assessments for dose-limiting toxicities, infusion reactions, mortality rates, tumor surveillance, and adverse events up to 24 months. Functional outcomes are evaluated using scales such as the modified Rankin Scale, NIH Stroke Scale, Barthel Index, and EQ-5D-5L at multiple timepoints up to 12 months. Monitoring includes imaging confirmation of stroke and laboratory tests. Participants are followed for safety and functional recovery throughout the study duration.
CONDITIONS
Brief 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 boundaries), any sex
- Ischemic stroke confirmed by CT or MRI imaging
- Time from stroke symptom onset to treatment 36 hours; for wake-up stroke, time defined as last-known-well
- NIH Stroke Scale score between 8 and 20 at screening
- Patient or legal representative agrees to participate and signs informed consent
You will not qualify if you...
- Received intravenous thrombolysis and/or mechanical thrombectomy before dosing
- Modified Rankin Scale score 2 before stroke onset
- Current intracranial hemorrhagic diseases, brain tumors, cerebrovascular malformations, multiple sclerosis, severe traumatic brain injury history, encephalitis, or other stroke-like conditions
- Unable to undergo CT or MRI scans
- Decreased consciousness level (NIHSS item 1a score 2)
- Major neurological or psychiatric disorders affecting trial compliance
- Body temperature above 38 0C or risk of infection prior to dosing
- Active uncontrolled infection or recent systemic anti-infective therapy
- Severe heart failure (NYHA Class III/IV), severe respiratory failure, severe kidney or liver disease, positive hepatitis or HIV markers, uncontrolled hypertension, or extreme blood glucose levels
- Abnormal lab tests including high liver enzymes, creatinine, low neutrophils, low platelets, low hemoglobin, or abnormal clotting times
- Malignant tumors or diseases with less than 2 years expected survival
- Immunodeficiency or current use of immunosuppressants
- Alcohol dependence or drug abuse history
- Pregnant or breastfeeding, or planning conception/donation without contraception
- Participation in another clinical trial within 1 month prior to screening
- Allergy to investigational product components
- Investigator judgment of unsuitability for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single dose with follow-up to 28 days
Participants receive an intravenous infusion of either the investigational drug B2065 or placebo.
Visits on Day 1, Day 7, Day 14, and Day 28
Duration - Up to 24 months after dosing
Participants are monitored for safety, tolerability, and efficacy including adverse events and functional outcomes.
Visits at Month 6, Month 12, and Month 24
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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