Autologous Cell Therapy After Stroke

Study Overview
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Brief Summary
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This study will examine the safety of two different cellular therapies in the treatment of stroke.

Detailed Description
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Biological: autologous bone marrow mononuclear cell transfusion
* Biological: marrow stromal cells
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: placebo<br>* 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<br>|
| Active Comparator: autologous mononuclear cells<br>a single intravenous autologous bone marrow mononuclear cell transfusion | Biological: autologous bone marrow mononuclear cell transfusion<br>* 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<br>* Other names: mononuclear cells;|
| Active Comparator: autologous marrow stromal cells<br>a single intravenous autologous marrow stromal cell transfusion | Biological: marrow stromal cells<br>* 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)<br>* Other names: mesenchymal stromal cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death |  | 90 days after stroke onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myocardial infarction |  | 90 days after stroke onset | 
| pulmonary embolism |  | 90 days after stroke onset | 
| ischemic stroke |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke cell therapy repair autologous