Study to Examine the Effects of MultiStem in Ischemic Stroke

Double-Blind, Randomized, Placebo-Controlled Phase 2 Safety and Efficacy Trial of MultiStem® in Adults With Ischemic Stroke

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01436487

Enrollment

134

Registered

2011-09-19

Start date

2011-10-31

Completion date

2015-12-31

Last updated

2016-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

ischemic stroke, adult stem cells

Brief summary

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.

Interventions

BIOLOGICALMultiStem

single infusion 1-2 days following ischemic stroke

BIOLOGICALPlacebo

single infusion 1-2 days following ischemic stroke

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 83 Years

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

Design outcomes

Primary

Measure	Time frame
frequency of dose limiting adverse events	7 days
Stroke recovery based on global test analysis including modified Rankin Scale (mRS), NIHSS, and Barthel Index (BI)	90 days

Secondary

Measure	Time frame	Description
frequency of adverse events	365 days	—
change in vital signs	365 days	—
proportion of subjects with a mRS score of less than or equal to 2	90 days	—
frequency of secondary infections	365 days	—
changes in outcome measures (mRS, NIHSS, BI) over time	365 days	—
change in safety labs	365 days	—
change in functional outcome throughout range of mRS scores	90 days	—
proportion of subjects with an excellent functional outcome	90 days	* mRS score = 0 to 1; and * NIHSS score = 0 to 1; and * Barthel Index score = greater than or equal to 95

Countries

United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026