Study to Examine the Effects of MultiStem in Ischemic Stroke

Completed

Phase 2 Results N/A

Trial Description

A study to examine the safety and potential effectiveness of the adult stem cell investigational product, MultiStem, in adults who have suffered an ischemic stroke. The hypothesis is that MultiStem will be safe and provide benefit following an ischemic stroke.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: single infusion 1-2 days following ischemic stroke
    ARM 1: Kind: Experimental
    Label: Cohort 1
    Description: Low dose MultiStem or Placebo
    ARM 2: Kind: Experimental
    Label: Cohort 2
    Description: High dose MultiStem or Placebo
    ARM 3: Kind: Experimental
    Label: Cohort 3
    Description: Highest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo
  • MultiStem Biological
    Intervention Desc: single infusion 1-2 days following ischemic stroke
    ARM 1: Kind: Experimental
    Label: Cohort 1
    Description: Low dose MultiStem or Placebo
    ARM 2: Kind: Experimental
    Label: Cohort 2
    Description: High dose MultiStem or Placebo
    ARM 3: Kind: Experimental
    Label: Cohort 3
    Description: Highest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary frequency of dose limiting adverse events 7 days Yes
Primary proportion of subjects with a modified Rankin Scale (mRS) score of less than or equal to 2 90 days No
Secondary change in functional outcome throughout range of mRS scores 90 days No
Secondary proportion of subjects with an excellent functional outcome 90 days No
Secondary frequency of adverse events 365 days Yes
Secondary change in vital signs 365 days Yes
Secondary change in safety labs 365 days Yes
Secondary frequency of secondary infections 365 days Yes
Primary Stroke recovery based on global test analysis including modified Rankin Scale (mRS), NIHSS, and Barthel Index (BI) 90 days No
Secondary proportion of subjects with a mRS score of less than or equal to 2 90 days No
Secondary changes in outcome measures (mRS, NIHSS, BI) over time 365 days No
Primary Stroke recovery based on global test analysis including modified Rankin Scale (mRS), NIHSS, and Barthel Index (BI) 90 days No

Sponsors