Autologous Cell Therapy After Stroke
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Status:
This study is not yet open for participant recruitment.
Purpose:
This study will examine the safety of two different cellular therapies in the treatment of stroke.
Year Started:
2010
Design:
Interventional, Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study.
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; 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.
Patient Involvement:
Patient will undergo NIHSS and bone marrow aspiration after enrollment in study. They will then be randomized to one of three arms: 1) 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; 2) 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; or 3) 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). All will receive standard physical, occupational and speech rehabilitation therapy for post-stroke. Then be evaluated for outcome at 90 days post-stroke.
Secondary Outcome:
Myocardial infarction, pulmonary embolism, ischemic stroke, deep venous thrombosis, other arterial or venous thrombosis,
infection requiring IV antibiotics.
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Source of Information:
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 10/16/2009
Reviewed on: 09/25/2009.
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