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MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2)

Primary Purpose

Ischemic Stroke

Status
Recruiting
Phase
Phase 3
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Athersys Investigational Site 128Recruiting
  • Athersys Investigational Site 122Recruiting
  • Athersys Investigational Site 127Recruiting
  • Athersys Investigational Site 129Recruiting
  • Athersys Investigational Site 108Recruiting
  • Athersys Investigational Site 103Recruiting
  • Athersys Investigational Site 121Recruiting
  • Athersys Investigational Site 119Recruiting
  • Athersys Investigational Site 124Recruiting
  • Athersys Investigational Site 113Recruiting
  • Athersys Investigational Site 125Recruiting
  • Athersys Investigational Site 111Recruiting
  • Athersys Investigational Site 109Recruiting
  • Athersys Investigational Site 104Recruiting
  • Athersys Investigational Site 130Recruiting
  • Athersys Investigational Site 102Recruiting
  • Athersys Investigational Site 107Recruiting
  • Athersys Investigational Site 106Recruiting
  • Athersys Investigational Site 118Recruiting
  • Athersys Investigational Site 115Recruiting
  • Athersys Investigational Site 101Recruiting
  • Athersys Investigational Site 105Recruiting
  • Athersys Investigational Site 110Recruiting
  • Athersys Investigational Site 603Recruiting
  • Athersys Investigational Site 601Recruiting
  • Athersys Investigational Site 602Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MultiStem

Placebo

Arm Description

1.2 billion cells

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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]
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]
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

Full Information

First Posted
May 23, 2018
Last Updated
February 8, 2022
Sponsor
Athersys, Inc
Collaborators
Medpace, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03545607
Brief Title
MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study
Acronym
MASTERS-2
Official Title
MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2018 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MultiStem
Arm Type
Experimental
Arm Description
1.2 billion cells
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
MultiStem
Intervention Description
single intravenous infusion 18-36 hours after stroke
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
single intravenous infusion 18-36 hours after stroke
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
proportion of subjects achieving an excellent functional outcome defined by all of the following criteria:
Description
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
Title
proportion of subjects achieving an excellent functional outcome defined by all of the following criteria:
Description
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Athersys Clinical Trials Group
Phone
(216) 426-3597
Email
masters2@athersys.com
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
Athersys Investigational Site 128
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 122
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 127
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 129
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 108
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 103
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 121
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 119
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 124
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 113
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 125
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 111
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 109
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 104
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 130
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 102
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 107
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 106
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 118
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 115
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 101
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 105
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 110
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216-426-3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 603
City
Taichung
ZIP/Postal Code
40402
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216 426 3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 601
City
Taipei City
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216 426 3597
Email
masters2@athersys.com
Facility Name
Athersys Investigational Site 602
City
Taoyuan City
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials
Phone
216 426 3597
Email
masters2@athersys.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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.
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MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study

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