MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study

Healios K.K.300 enrolled

Overview

A Phase 3 study to examine the safety and effectiveness of the allogeneic, adult stem cell investigational product, MultiStem, in adults who have suffered an acute ischemic stroke in the previous 18-36 hours.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

300

Conditions

Ischemic Stroke

Interventions

MultiStemBIOLOGICAL

single intravenous infusion 18-36 hours after stroke

PlaceboBIOLOGICAL

single intravenous infusion 18-36 hours after stroke

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Primary Inclusion Criteria: * Male or female subjects ≥18 years of age * Clinical diagnosis of ischemic stroke involving cerebral cortex * Occurrence of a moderate to moderately severe stroke with a persistent neurologic deficit documented by a NIHSS score of 8 to 20 (inclusive) that does not change by ≥4 points during the initial screening period * A mRS score of 0 or 1 prior to the onset of symptoms of the current stroke Primary Exclusion Criteria: * Presence of a lacunar or a brainstem infarct * Comatose state * Brain hemorrhage * Major neurological event such as stroke or clinically significant head trauma within 6 months of enrollment into the study

Locations (26)

Outcomes

Primary Outcomes

assessment of disability by examining the distribution of modified Rankin Scale (mRS) scores [scale range = 0 to 6] evaluated by shift analysis

Time frame: 90 days

Secondary Outcomes

proportion of subjects achieving an excellent functional outcome defined by all of the following criteria:

mRS score = 0 to 1 \[scale range 0 to 6\]; and NIHSS score = 0 to 1 \[scale range 0 to 42\]; and Barthel Index score = greater than or equal to 95 \[scale range 0 to 100\]

Time frame: 365 days

proportion of subjects achieving an excellent functional outcome defined by all of the following criteria:

mRS score = 0 to 1 \[scale range 0 to 6\]; and NIHSS score = 0 to 1 \[scale range 0 to 42\]; and Barthel Index score = greater than or equal to 95 \[scale range 0 to 100\]

Time frame: 90 days

proportion of subjects with a mRS score of less than or equal to 2 [scale range 0 to 6] demonstrating the ability to function independently

Time frame: 90 days

Central Contacts

Athersys Clinical Trials Group

CONTACT

(216) 426-3597 masters2@athersys.com

Data from ClinicalTrials.gov

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Athersys Investigational Site 128

Phoenix, Arizona, United States

RECRUITING

Athersys Investigational Site 122

Palo Alto, California, United States

RECRUITING

Athersys Investigational Site 127

Sacramento, California, United States

RECRUITING

Athersys Investigational Site 129

Clearwater, Florida, United States

RECRUITING

Athersys Investigational Site 108

Miami, Florida, United States

RECRUITING

Athersys Investigational Site 103

Augusta, Georgia, United States

RECRUITING

Athersys Investigational Site 121

Chicago, Illinois, United States

RECRUITING

Athersys Investigational Site 119

Kansas City, Kansas, United States

RECRUITING

Athersys Investigational Site 124

Wichita, Kansas, United States

RECRUITING

Athersys Investigational Site 113

Boston, Massachusetts, United States

RECRUITING

...and 16 more locations