Status:
WITHDRAWN
Safety of Escalating Doses of Intravenous Bone Marrow-Derived Mesenchymal Stem Cells in Patients With a New Ischemic Stroke
Lead Sponsor:
University of California, Irvine
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Stroke is a major cause of adult disability. Currently approved reperfusion therapies are provided to only a small percentage of patients in the U.S. New therapies are needed that improve outcome and ...
Eligibility Criteria
Inclusion
- 1\. Ischemic stroke in the middle cerebral artery territory, with onset 24-72 hours prior to the time that the therapy transfusion is initiated, radiologically confirmed, and with either diameter \>15 mm or volume \> 4cc.
- 2\. The index stroke has clinical deficits that are moderate-severe (NIHSS score 7-20), did not require hemicraniectomy or invasive intracranial pressure monitoring, and was not associated with a concomitant STelevation myocardial infarction.
- 3\. Age 18-80 years, inclusive
- 4\. Reasonable likelihood of receiving standard post-stroke medical care, as well as standard physical, occupational, and speech therapy.
Exclusion
- 1\. No substantial pre-stroke disability (pre-stroke modified Rankin Scale score 0-2).
- 2\. Females of child-bearing potential will be excluded unless (1) a negative urine pregnancy test is obtained and (2) the patient has been effectively using contraceptive method with known failure rate \<1 % for at least 90 days.
- 3\. Lactating mothers
- 4\. If thrombolytic therapy has been administered, at least 24 hours have passed between completing thrombolytic dosing and initiating the current study's transfusion.
- 5\. Known allergy to penicillin or to fetal bovine serum
- 6\. Active co-existent major neurological or psychiatric disease that could significantly interfere with patient compliance or study assessments, including drug or alcohol abuse.
- 7\. Any diagnosis that makes survival to 1-year post-stroke unlikely.
- 8\. Participation in any other experimental therapeutic clinical trial concurrently or in the prior three months.
- 9\. Contraindication to undergoing MRI scanning.
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01849887
Start Date
January 1 2016
End Date
January 1 2016
Last Update
January 22 2016
Active Locations (1)
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1
University of California Irvine Medical Center
Orange, California, United States, 92868