Study to Examine the Effects of MultiStem in Ischemic Stroke

July 29, 2016 updated by: Athersys, Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G11 6NT
        • University of Glasgow - Western Infirmary
      • Glasgow, United Kingdom, G12 8QQ
        • University of Glasgow - Southern General Hospital
      • London, United Kingdom, SW17 0QT
        • St. Georges Healthcare NHS Trust
      • London, United Kingdom, WC1E 6BT
        • University College London Hospitals - Thames Stroke Research Network
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • The Newcastle upon Tyne Hospitals, NHS Foundation Trust
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • University Hospital of North Staffordshire
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • Stanford, California, United States, 94305
        • Stanford University
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
      • Orlando, Florida, United States, 32803
        • Florida Hospital Orlando
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Georgia Regents University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Medical Center
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Nebraska
      • Omaha, Nebraska, United States, 68198-2045
        • University of Nebraska Medical Center
    • Ohio
      • Akron, Ohio, United States, 44320
        • Summa Health System
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University School of Medicine
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Sciences University
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • The Pennsylvania State University
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital for the University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center Health System
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Palmetto Health Richland
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Chattanooga Center for Neurologic Research
    • Texas
      • Houston, Texas, United States, 77030
        • Methodist Hospital Research Institute
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Low dose MultiStem or Placebo
Biological: MultiStem
single infusion 1-2 days following ischemic stroke
Biological: Placebo
single infusion 1-2 days following ischemic stroke
Experimental: Cohort 2
High dose MultiStem or Placebo
Biological: MultiStem
single infusion 1-2 days following ischemic stroke
Biological: Placebo
single infusion 1-2 days following ischemic stroke
Experimental: Cohort 3
Highest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo
Biological: MultiStem
single infusion 1-2 days following ischemic stroke
Biological: Placebo
single infusion 1-2 days following ischemic stroke

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Athersys, Inc

Collaborators

Medpace, Inc.

Investigators

  • Study Director: Robert W Mays, PhD, Athersys, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 15, 2011

First Submitted That Met QC Criteria

September 16, 2011

First Posted (Estimate)

September 19, 2011

Study Record Updates

Last Update Posted (Estimate)

August 2, 2016

Last Update Submitted That Met QC Criteria

July 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B01-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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