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| Name | Class |
|---|---|
| Medpace, Inc. | INDUSTRY |
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A study to examine the safety and potential effectiveness of the adult stem cell investigational product, MultiStem, in adults who have suffered an ischemic stroke. The hypothesis is that MultiStem will be safe and provide benefit following an ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Low dose MultiStem or Placebo |
|
| Cohort 2 | Experimental | High dose MultiStem or Placebo |
|
| Cohort 3 | Experimental | Highest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MultiStem | Biological | single infusion 1-2 days following ischemic stroke |
|
| Measure | Description | Time Frame |
|---|---|---|
| frequency of dose limiting adverse events | 7 days | |
| Stroke recovery based on global test analysis including modified Rankin Scale (mRS), NIHSS, and Barthel Index (BI) | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of subjects with a mRS score of less than or equal to 2 | 90 days | |
| change in functional outcome throughout range of mRS scores | 90 days | |
| changes in outcome measures (mRS, NIHSS, BI) over time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert W Mays, PhD | Healios K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90095 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28320635 | Derived | 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 infusion 1-2 days following ischemic stroke |
|
| 365 days |
| proportion of subjects with an excellent functional outcome |
| 90 days |
| frequency of adverse events | 365 days |
| change in vital signs | 365 days |
| change in safety labs | 365 days |
| frequency of secondary infections | 365 days |
| Stanford |
| California |
| 94305 |
| United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Florida Hospital Orlando | Orlando | Florida | 32803 | United States |
| Georgia Regents University | Augusta | Georgia | 30912 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Boston University | Boston | Massachusetts | 02118 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-2045 | United States |
| Summa Health System | Akron | Ohio | 44320 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Case Western Reserve University School of Medicine | Cleveland | Ohio | 44106 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Oregon Health Sciences University | Portland | Oregon | 97239 | United States |
| The Pennsylvania State University | Hershey | Pennsylvania | 17033-0850 | United States |
| Hospital for the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center Health System | Pittsburgh | Pennsylvania | 15213 | United States |
| Palmetto Health Richland | Columbia | South Carolina | 29203 | United States |
| Chattanooga Center for Neurologic Research | Chattanooga | Tennessee | 37403 | United States |
| Methodist Hospital Research Institute | Houston | Texas | 77030 | United States |
| The University of Texas Health Science Center | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| University of Glasgow - Western Infirmary | Glasgow | G11 6NT | United Kingdom |
| University of Glasgow - Southern General Hospital | Glasgow | G12 8QQ | United Kingdom |
| St. Georges Healthcare NHS Trust | London | SW17 0QT | United Kingdom |
| University College London Hospitals - Thames Stroke Research Network | London | WC1E 6BT | United Kingdom |
| The Newcastle upon Tyne Hospitals, NHS Foundation Trust | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| University Hospital of North Staffordshire | Stoke-on-Trent | ST4 6QG | United Kingdom |
| 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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