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Study to Examine the Effects of MultiStem in Ischemic Stroke

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MultiStem
Placebo
Sponsored by
Athersys, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring ischemic stroke, adult stem cells

Eligibility Criteria

18 Years - 83 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UCLA Medical Center
  • Stanford University
  • University of Miami
  • Florida Hospital Orlando
  • Georgia Regents University
  • Northwestern University
  • University of Kentucky Medical Center
  • University of Louisville
  • Boston University
  • Henry Ford Health System
  • University of Mississippi Medical Center
  • University of Nebraska Medical Center
  • Summa Health System
  • University of Cincinnati
  • Case Western Reserve University School of Medicine
  • MetroHealth Medical Center
  • Cleveland Clinic
  • Oregon Health Sciences University
  • The Pennsylvania State University
  • Hospital for the University of Pennsylvania
  • University of Pittsburgh Medical Center Health System
  • Palmetto Health Richland
  • Chattanooga Center for Neurologic Research
  • Methodist Hospital Research Institute
  • The University of Texas Health Science Center
  • University of Utah
  • University of Glasgow - Western Infirmary
  • University of Glasgow - Southern General Hospital
  • St. Georges Healthcare NHS Trust
  • University College London Hospitals - Thames Stroke Research Network
  • The Newcastle upon Tyne Hospitals, NHS Foundation Trust
  • University Hospital of North Staffordshire

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

Low dose MultiStem or Placebo

High dose MultiStem or Placebo

Highest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 15, 2011
Last Updated
July 29, 2016
Sponsor
Athersys, Inc
Collaborators
Medpace, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01436487
Brief Title
Study to Examine the Effects of MultiStem in Ischemic Stroke
Official Title
Double-Blind, Randomized, Placebo-Controlled Phase 2 Safety and Efficacy Trial of MultiStem® in Adults With Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Athersys, Inc
Collaborators
Medpace, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
ischemic stroke, adult stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Low dose MultiStem or Placebo
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
High dose MultiStem or Placebo
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Highest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo
Intervention Type
Biological
Intervention Name(s)
MultiStem
Intervention Description
single infusion 1-2 days following ischemic stroke
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
single infusion 1-2 days following ischemic stroke
Primary Outcome Measure Information:
Title
frequency of dose limiting adverse events
Time Frame
7 days
Title
Stroke recovery based on global test analysis including modified Rankin Scale (mRS), NIHSS, and Barthel Index (BI)
Time Frame
90 days
Secondary Outcome Measure Information:
Title
proportion of subjects with a mRS score of less than or equal to 2
Time Frame
90 days
Title
change in functional outcome throughout range of mRS scores
Time Frame
90 days
Title
changes in outcome measures (mRS, NIHSS, BI) over time
Time Frame
365 days
Title
proportion of subjects with an excellent functional outcome
Description
mRS score = 0 to 1; and NIHSS score = 0 to 1; and Barthel Index score = greater than or equal to 95
Time Frame
90 days
Title
frequency of adverse events
Time Frame
365 days
Title
change in vital signs
Time Frame
365 days
Title
change in safety labs
Time Frame
365 days
Title
frequency of secondary infections
Time Frame
365 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
83 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert W Mays, PhD
Organizational Affiliation
Athersys, Inc
Official's Role
Study Director
Facility Information:
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Florida Hospital Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Georgia Regents University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-2045
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44320
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Case Western Reserve University School of Medicine
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
The Pennsylvania State University
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Hospital for the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center Health System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Palmetto Health Richland
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Chattanooga Center for Neurologic Research
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Methodist Hospital Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Glasgow - Western Infirmary
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
University of Glasgow - Southern General Hospital
City
Glasgow
ZIP/Postal Code
G12 8QQ
Country
United Kingdom
Facility Name
St. Georges Healthcare NHS Trust
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
University College London Hospitals - Thames Stroke Research Network
City
London
ZIP/Postal Code
WC1E 6BT
Country
United Kingdom
Facility Name
The Newcastle upon Tyne Hospitals, NHS Foundation Trust
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
University Hospital of North Staffordshire
City
Stoke-on-Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28320635
Citation
Hess DC, Wechsler LR, Clark WM, Savitz SI, Ford GA, Chiu D, Yavagal DR, Uchino K, Liebeskind DS, Auchus AP, Sen S, Sila CA, Vest JD, Mays RW. Safety and efficacy of multipotent adult progenitor cells in acute ischaemic stroke (MASTERS): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2017 May;16(5):360-368. doi: 10.1016/S1474-4422(17)30046-7. Epub 2017 Mar 17.
Results Reference
derived

Learn more about this trial

Study to Examine the Effects of MultiStem in Ischemic Stroke

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