Stroke
Conditions
Keywords
stroke cell therapy repair autologous
Brief summary
This study will examine the safety of two different cellular therapies in the treatment of stroke.
Detailed description
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.
Interventions
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
BIOLOGICALmarrow stromal cells
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)
DRUGplacebo
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
Sponsors
University of California, San Diego
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Ischemic stroke that is supratentorial in location and \< 72 hours old between stroke onset and bone marrow aspiration * No major pre-stroke disability * NIH stroke scale score of 7-24 * Able to undergo bedside bone marrow aspiration * Age 18-85 years, inclusive * Reasonable likelihood of receiving standard physical, occupational and speech rehabilitation therapy
Exclusion criteria
* No major active hematological, immunological, or oncological diagnoses * Pregnancy * Lactating mothers * At least 24 hours time of any thrombolytic therapy and time of bone marrow aspiration * Allergy to penicillin or to fetal bovine serum * Active, major co-existent neurological or psychiatric disease * Infection with HIV, hepatitis B or C, or syphilis * Any diagnosis that makes survival to 90 days post-stroke unlikely * Participation in an experimental therapeutic clinical trial in the prior three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| death | 90 days after stroke onset |
Secondary
| Measure | Time frame |
|---|---|
| pulmonary embolism | 90 days after stroke onset |
| ischemic stroke | 90 days after stroke onset |
| myocardial infarction | 90 days after stroke onset |
| other arterial or venous thrombosis | 90 days after stroke onset |
| Infection requiring IV antibiotics | 90 days after stroke onset |
| deep venous thrombosis | 90 days after stroke onset |
Countries
United States
Outcome results
None listed