Status:
WITHDRAWN
Autologous Cell Therapy After Stroke
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
University of California, San Diego
Conditions:
Stroke
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00908856
Start Date
January 1 2016
End Date
December 1 2017
Last Update
February 4 2016
Active Locations (1)
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1
UC Irvine Medical Center
Orange, California, United States, 92868