MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study
MASTERS-2
1 other identifier
interventional
300
2 countries
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2018
Longer than P75 for phase_3
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2018
CompletedFirst Posted
Study publicly available on registry
June 4, 2018
CompletedStudy Start
First participant enrolled
July 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedFebruary 9, 2022
February 1, 2022
4.1 years
May 23, 2018
February 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
assessment of disability by examining the distribution of modified Rankin Scale (mRS) scores [scale range = 0 to 6] evaluated by shift analysis
90 days
Secondary Outcomes (3)
proportion of subjects achieving an excellent functional outcome defined by all of the following criteria:
365 days
proportion of subjects achieving an excellent functional outcome defined by all of the following criteria:
90 days
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
90 days
Study Arms (2)
MultiStem
EXPERIMENTAL1.2 billion cells
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Healios K.K.lead
- Medpace, Inc.collaborator
Study Sites (26)
Athersys Investigational Site 128
Phoenix, Arizona, 85013, United States
Athersys Investigational Site 122
Palo Alto, California, 94304, United States
Athersys Investigational Site 127
Sacramento, California, 95817, United States
Athersys Investigational Site 129
Clearwater, Florida, 33756, United States
Athersys Investigational Site 108
Miami, Florida, 33136, United States
Athersys Investigational Site 103
Augusta, Georgia, 30912, United States
Athersys Investigational Site 121
Chicago, Illinois, 60201, United States
Athersys Investigational Site 119
Kansas City, Kansas, 66160, United States
Athersys Investigational Site 124
Wichita, Kansas, 67214, United States
Athersys Investigational Site 113
Boston, Massachusetts, 02114, United States
Athersys Investigational Site 125
Minneapolis, Minnesota, 55455, United States
Athersys Investigational Site 111
Jackson, Mississippi, 39216, United States
Athersys Investigational Site 109
Akron, Ohio, 44304, United States
Athersys Investigational Site 104
Cleveland, Ohio, 44195, United States
Athersys Investigational Site 130
Toledo, Ohio, 43606, United States
Athersys Investigational Site 102
Portland, Oregon, 97239, United States
Athersys Investigational Site 107
Hershey, Pennsylvania, 17033, United States
Athersys Investigational Site 106
Pittsburgh, Pennsylvania, 15213, United States
Athersys Investigational Site 118
Columbia, South Carolina, 29203, United States
Athersys Investigational Site 115
Chattanooga, Tennessee, 37403, United States
Athersys Investigational Site 101
Houston, Texas, 77030, United States
Athersys Investigational Site 105
Houston, Texas, 77030, United States
Athersys Investigational Site 110
Salt Lake City, Utah, 84112, United States
Athersys Investigational Site 603
Taichung, 40402, Taiwan
Athersys Investigational Site 601
Taipei, 10002, Taiwan
Athersys Investigational Site 602
Taoyuan, 33305, Taiwan
Related Publications (1)
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.
PMID: 28320635BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert W Mays, PhD
Healios K.K.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2018
First Posted
June 4, 2018
Study Start
July 28, 2018
Primary Completion
September 1, 2022
Study Completion
June 1, 2023
Last Updated
February 9, 2022
Record last verified: 2022-02