MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2)
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| ClinicalTrials.gov Identifier: NCT03545607 |
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Recruitment Status :
Recruiting
First Posted : June 4, 2018
Last Update Posted : February 9, 2022
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Sponsor:
Athersys, Inc
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Athersys, Inc
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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) |
| Actual Study Start Date : | July 28, 2018 |
| Estimated Primary Completion Date : | September 2022 |
| Estimated Study Completion Date : | June 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Ischemic Stroke
| Arm | Intervention/treatment |
|---|---|
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Experimental: MultiStem
1.2 billion cells
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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 :
- 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 :
- 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]
- 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]
- 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 ]
Information from the National Library of Medicine
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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
Show 26 study locations
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 |
| Other Study ID Numbers: |
B01-04 |
| First Posted: | June 4, 2018 Key Record Dates |
| Last Update Posted: | February 9, 2022 |
| Last Verified: | February 2022 |
| 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:
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ischemic stroke adult stem cells |
Additional relevant MeSH terms:
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Stroke Ischemic Stroke Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |