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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
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This study will examine the safety of two different cellular therapies in the treatment of stroke.
Stroke remains a leading cause of death and disability. A limited number of therapies, such as intravenous tissue plasminogen activator, have been approved to interrupt stroke in the early hours after symptom onset. Many patients are not able to benefit from these therapies, however, and so a need exists for development of new interventions to reduce disability after stroke. This study will be an early step towards this, and will examine the safety of two cell types, mononuclear cells and marrow stromal cells. In each case, the cells will be autologous, specifically being derived from the subject's own bone marrow.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| autologous mononuclear cells | Active Comparator | a single intravenous autologous bone marrow mononuclear cell transfusion |
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| autologous marrow stromal cells | Active Comparator | a single intravenous autologous marrow stromal cell transfusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous bone marrow mononuclear cell transfusion | Biological | a single intravenous transfusion approximately 2 days after bone marrow aspiration, and 4 days after stroke onset; the full amount of autologous mononuclear cells derived from 30 cc of bone marrow |
| Measure | Description | Time Frame |
|---|---|---|
| death | 90 days after stroke onset |
| Measure | Description | Time Frame |
|---|---|---|
| myocardial infarction | 90 days after stroke onset | |
| pulmonary embolism | 90 days after stroke onset | |
| ischemic stroke |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven C. Cramer, MD, MMSc | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Irvine Medical Center | Orange | California | 92868 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19389020 | Background | Lane TA, Garls D, Mackintosh E, Kohli S, Cramer SC. Liquid storage of marrow stromal cells. Transfusion. 2009 Jul;49(7):1471-81. doi: 10.1111/j.1537-2995.2009.02138.x. Epub 2009 Mar 31. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C483480 | SLC25A33 protein, human |
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| marrow stromal cells | Biological | a single intravenous transfusion approximately 21 days after bone marrow aspiration, and 23 days after stroke onset; the full amount of marrow stromal cells cultured over 21 days from 30 cc of bone marrow (expected to be approximately 1,000,000 cells/kg body weight) |
|
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| placebo | Drug | a single intravenous transfusion of saline, approximately 2-21 days after bone marrow aspiration, and 4-23 days after stroke onset; the full amount of mononuclear cells derived from 30 cc of bone marrow |
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| 90 days after stroke onset |
| deep venous thrombosis | 90 days after stroke onset |
| other arterial or venous thrombosis | 90 days after stroke onset |
| Infection requiring IV antibiotics | 90 days after stroke onset |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |