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| Name | Class |
|---|---|
| Medpace, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MultiStem | Experimental | 1.2 billion cells |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MultiStem | Biological | single intravenous infusion 18-36 hours after stroke |
| |
| Measure | Description | Time Frame |
|---|---|---|
| assessment of disability by examining the distribution of modified Rankin Scale (mRS) scores [scale range = 0 to 6] evaluated by shift analysis | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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] | 365 days |
| proportion of subjects achieving an excellent functional outcome defined by all of the following criteria: |
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Primary Inclusion Criteria:
Primary Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Athersys Clinical Trials Group | Contact | (216) 426-3597 | masters2@athersys.com |
| Name | Affiliation | Role |
|---|---|---|
| Robert W Mays, PhD | Healios K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Athersys Investigational Site 128 | Recruiting | Phoenix | Arizona | 85013 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28320635 | Background | 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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| Placebo |
| Biological |
single intravenous infusion 18-36 hours after stroke |
|
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] |
| 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 |
| Athersys Investigational Site 122 | Recruiting | Palo Alto | California | 94304 | United States |
|
| Athersys Investigational Site 127 | Recruiting | Sacramento | California | 95817 | United States |
|
| Athersys Investigational Site 129 | Recruiting | Clearwater | Florida | 33756 | United States |
|
| Athersys Investigational Site 108 | Recruiting | Miami | Florida | 33136 | United States |
|
| Athersys Investigational Site 103 | Recruiting | Augusta | Georgia | 30912 | United States |
|
| Athersys Investigational Site 121 | Recruiting | Chicago | Illinois | 60201 | United States |
|
| Athersys Investigational Site 119 | Recruiting | Kansas City | Kansas | 66160 | United States |
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| Athersys Investigational Site 124 | Recruiting | Wichita | Kansas | 67214 | United States |
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| Athersys Investigational Site 113 | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Athersys Investigational Site 125 | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| Athersys Investigational Site 111 | Recruiting | Jackson | Mississippi | 39216 | United States |
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| Athersys Investigational Site 109 | Recruiting | Akron | Ohio | 44304 | United States |
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| Athersys Investigational Site 104 | Recruiting | Cleveland | Ohio | 44195 | United States |
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| Athersys Investigational Site 130 | Recruiting | Toledo | Ohio | 43606 | United States |
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| Athersys Investigational Site 102 | Recruiting | Portland | Oregon | 97239 | United States |
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| Athersys Investigational Site 107 | Recruiting | Hershey | Pennsylvania | 17033 | United States |
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| Athersys Investigational Site 106 | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| Athersys Investigational Site 118 | Recruiting | Columbia | South Carolina | 29203 | United States |
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| Athersys Investigational Site 115 | Recruiting | Chattanooga | Tennessee | 37403 | United States |
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| Athersys Investigational Site 101 | Recruiting | Houston | Texas | 77030 | United States |
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| Athersys Investigational Site 105 | Recruiting | Houston | Texas | 77030 | United States |
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| Athersys Investigational Site 110 | Recruiting | Salt Lake City | Utah | 84112 | United States |
|
| Athersys Investigational Site 603 | Recruiting | Taichung | 40402 | Taiwan |
|
| Athersys Investigational Site 601 | Recruiting | Taipei | 10002 | Taiwan |
|
| Athersys Investigational Site 602 | Recruiting | Taoyuan City | 33305 | Taiwan |
|
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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