Autologous Cell Therapy After Stroke

Safety of IV Autologous Mononuclear Cells and Marrow Stromal Cells After Stroke

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.

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