Treatment Evaluation of Acute Stroke for Using in Regenerative Cell Elements "TREASURE"

Not yet recruiting

Phase 2/3 Results N/A

Trial Description

The primary objectives of this study is to evaluate the efficacy of HLCM051 on functional outcome in subjects with acute ischemic stroke and to evaluate the safety of HLCM051 in subjects with acute ischemic stroke.

Detailed Description

This is a randomized, placebo-controlled, double-blind, multicenter, phase 2/3 trial to evaluate the efficacy and safety of intravenous administration of HLCM051 compared with placebo in subjects with acute ischemic stroke (within 36 hours of onset). Japanese subjects who developed a subcortical ischemic stroke and are eligible to participate in the trial will be evaluated.
Approximately 220 subjects will be randomized in a 1:1 ratio (HLCM051 group [n=110] or placebo group [n=110]) to receive a single infusion of HLCM051 or placebo.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Within 18 to 36 hours after the onset of ischemic stroke, subjects will receive a single dose of placebo to be intravenously administered
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: a single dose of placebo
  • HLCM051 Biological
    Intervention Desc: Within 18 to 36 hours after the onset of ischemic stroke, subjects will receive a single dose of 1.2 billion HLCM051 cells to be intravenously administered
    ARM 1: Kind: Experimental
    Label: HLCM051 (MultiStem)
    Description: single dose of 1.2 billion HLCM051 cells

Outcomes

Type Measure Time Frame Safety Issue
Primary Proportion of subjects with an excellent outcome defined by the functional assessments Day 90
Primary Comparison between the HLCM051 and the placebo groups in key adverse events within Day90
Secondary Proportion of subjects exhibiting functional outcome throughout the range of mRS scores by shift analysis Day 90
Secondary Proportion of subjects who meet all of a mRS score of ≤2, NIHSS score improvement of ≥75% from baseline and a BI score of ≥95 Day 90
Secondary Proportion of subjects with a mRS score of ≤1 and a mRS score of ≤2 Day 90
Secondary Proportion of subjects with a NIHSS score of ≤1 Day 90
Secondary Proportion of subjects with a favorable outcome (NIHSS score improvement of ≥75% from baseline) in neurological symptoms Day 90
Secondary Proportion of subjects with a BI score of ≥95 Day 90
Secondary Proportion of subjects who survived without life-threatening adverse events (AEs) Day 90
Secondary Proportion of subjects who survived without secondary infections Day 90
Secondary Global recovery (i.e., GEE) and dichotomous assessment Day 90
Secondary Comparison of the incidence of secondary infections (local and systemic), AEs, death, vital signs and laboratory parameters between the HLCM051 and the placebo groups 1 year

Sponsors