Study to Examine the Effects of MultiStem in Ischemic Stroke

Phase 2

Completed

• Conditions: Ischemic Stroke

• Registration Number: NCT01436487
• Lead Sponsor: Healios K.K.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-15
• Study First Submitted QC: 2011-09-16
• Study First Posted: 2011-09-19
• Study Start: 2011-10
• Primary Completion: 2015-03
• Study Completion: 2015-12
• Status Verified: 2016-07
• Disposition First Submitted: 2016-07-29
• Disposition First Submitted QC: 2016-07-29
• Last Update Submitted: 2016-07-29
• Disposition First Posted: 2016-08-02
• Last Update Posted: 2016-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
proportion of subjects with a mRS score of less than or equal to 2	90 days
change in functional outcome throughout range of mRS scores	90 days
changes in outcome measures (mRS, NIHSS, BI) over time	365 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
frequency of adverse events	365 days
change in vital signs	365 days
change in safety labs	365 days
frequency of secondary infections	365 days

Trial Locations

Locations (32)

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Stanford University; 🇺🇸 Stanford, California, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Florida Hospital Orlando; 🇺🇸 Orlando, Florida, United States

Georgia Regents University; 🇺🇸 Augusta, Georgia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

University of Kentucky Medical Center; 🇺🇸 Lexington, Kentucky, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

Boston University; 🇺🇸 Boston, Massachusetts, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

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