Study to Examine the Effects of MultiStem in Ischemic Stroke

Healios

Status and phase: Completed; Phase 2

Conditions: Ischemic Stroke

Treatments: Biological: Placebo; Biological: MultiStem

Study type: Interventional

Funder types: Industry

Identifiers

NCT01436487

B01-02

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 18 to 83 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects between 18 and 83 years of age (inclusive)
• Clinical diagnosis of cortical cerebral ischemic stroke
• Occurrence of a moderate to moderately severe stroke

Exclusion criteria

• Presence of a lacunar or a brainstem infarct
• Reduced level of consciousness
• Major neurological event such as stroke or clinically significant head trauma within 6 months of study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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134 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Low dose MultiStem or Placebo

Treatment:

Biological: Placebo

Biological: MultiStem

Cohort 2

Experimental group

Description:

High dose MultiStem or Placebo

Treatment:

Biological: Placebo

Biological: MultiStem

Cohort 3

Experimental group

Description:

Highest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo

Treatment:

Biological: Placebo

Biological: MultiStem