Ischemic Stroke
Conditions
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 that can be accessed by a majority of patients. Animal studies suggest that bone marrow-derived mesenchymal stem cells, administered intravenously days after a stroke, safely improve long-term behavioral outcome. A large human experience suggests the safety of allogeneic bone marrow-derived mesenchymal stem cells. The current study aims to assess the safety of this therapy in patients with recent ischemic stroke.
Interventions
bone marrow-derived mesenchymal stem cells
DRUGPlacebo
Placebo
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Adverse Events | 1 month after transfusion |
Countries
United States
Outcome results
None listed