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

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ClinicalTrials.gov Identifier: NCT03545607
Recruitment Status : Recruiting
First Posted : June 4, 2018
Last Update Posted : July 30, 2018
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Athersys, Inc

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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Biological: MultiStem Biological: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2)
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: MultiStem
1.2 billion cells
Biological: MultiStem
single intravenous infusion 18-36 hours after stroke

Placebo Comparator: Placebo Biological: Placebo
single intravenous infusion 18-36 hours after stroke




Primary Outcome Measures :
  1. 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 Measures :
  1. proportion of subjects achieving an excellent functional outcome defined by all of the following criteria: [ Time Frame: 365 days ]
    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]

  2. proportion of subjects achieving an excellent functional outcome defined by all of the following criteria: [ Time Frame: 90 days ]
    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]

  3. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03545607


Contacts
Contact: Athersys Clinical Trials Group (216) 426-3597 masters2@athersys.com

Locations
United States, Georgia
Athersys Investigational Site 103 Not yet recruiting
Augusta, Georgia, United States, 30912
Contact: Athersys Clinical Trials    216-426-3597    masters2@athersys.com   
United States, Ohio
Athersys Investigational Site 104 Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Athersys Clinical Trials    216-426-3597    masters2@athersys.com   
United States, Oregon
Athersys Investigational Site 102 Recruiting
Portland, Oregon, United States, 97239
Contact: Athersys Clinical Trials    216-426-3597    masters2@athersys.com   
United States, Pennsylvania
Athersys Investigational Site 106 Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Athersys Clinical Trials    216-426-3597    masters2@athersys.com   
United States, Texas
Athersys Investigational Site 101 Not yet recruiting
Houston, Texas, United States, 77030
Contact: Athersys Clinical Trials    216-426-3597    masters2@athersys.com   
Athersys Investigational Site 105 Not yet recruiting
Houston, Texas, United States, 77030
Contact    216-426-3597    masters2@athersys.com   
Sponsors and Collaborators
Athersys, Inc
Medpace, Inc.
Investigators
Study Director: Robert W Mays, PhD Athersys, Inc

Publications:
Responsible Party: Athersys, Inc
ClinicalTrials.gov Identifier: NCT03545607     History of Changes
Other Study ID Numbers: B01-04
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Athersys, Inc:
ischemic stroke
adult stem cells

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases