Phase IIIa Study of B2065, an Allogeneic Mesenchymal Stem Cell Infusion, for Safety and Early Effects in Adults With Acute Ischemic Stroke

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 IIIa 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 21 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 5.0107 cells, 1.5108 cells, and 4.5108 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.

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