Study to Examine the Effects of MultiStem in Ischemic Stroke

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01436487
• Other study ID #: B01-02
• Status: Completed
• Phase: Phase 2
• First received: September 15, 2011
• Last updated: July 29, 2016
• Start date: October 2011
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: Athersys, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: December 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 83 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Biological:
• MultiStem
single infusion 1-2 days following ischemic stroke
• Placebo
single infusion 1-2 days following ischemic stroke

Locations

Country	Name	City	State
United Kingdom	University of Glasgow - Southern General Hospital	Glasgow
United Kingdom	University of Glasgow - Western Infirmary	Glasgow
United Kingdom	St. Georges Healthcare NHS Trust	London
United Kingdom	University College London Hospitals - Thames Stroke Research Network	London
United Kingdom	The Newcastle upon Tyne Hospitals, NHS Foundation Trust	Newcastle upon Tyne
United Kingdom	University Hospital of North Staffordshire	Stoke-on-Trent
United States	Summa Health System	Akron	Ohio
United States	Georgia Regents University	Augusta	Georgia
United States	Boston University	Boston	Massachusetts
United States	Chattanooga Center for Neurologic Research	Chattanooga	Tennessee
United States	Northwestern University	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Case Western Reserve University School of Medicine	Cleveland	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Palmetto Health Richland	Columbia	South Carolina
United States	Henry Ford Health System	Detroit	Michigan
United States	The Pennsylvania State University	Hershey	Pennsylvania
United States	Methodist Hospital Research Institute	Houston	Texas
United States	The University of Texas Health Science Center	Houston	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	UCLA Medical Center	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	University of Miami	Miami	Florida
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Florida Hospital Orlando	Orlando	Florida
United States	Hospital for the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center Health System	Pittsburgh	Pennsylvania
United States	Oregon Health Sciences University	Portland	Oregon
United States	University of Utah	Salt Lake City	Utah
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Athersys, Inc	Medpace, Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of dose limiting adverse events		7 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	change in functional outcome throughout range of mRS scores		90 days	No
Secondary	changes in outcome measures (mRS, NIHSS, BI) over time		365 days	No
Secondary	proportion of subjects with an excellent functional outcome	mRS score = 0 to 1; and; NIHSS score = 0 to 1; and; Barthel Index score = greater than or equal to 95	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