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Safety of Escalating Doses of Intravenous Bone Marrow-Derived Mesenchymal Stem Cells in Patients With a New Ischemic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01849887
Recruitment Status : Withdrawn (Study was never started)
First Posted : May 9, 2013
Last Update Posted : January 22, 2016
Information provided by (Responsible Party):
Steven C. Cramer, MD, University of California, Irvine

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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Biological: bone marrow-derived mesenchymal stem cells Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety of Escalating Doses of Intravenous Bone Marrow-Derived Mesenchymal Stem Cells in Patients With a New Ischemic Stroke
Study Start Date : January 2016
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Arm Intervention/treatment
Active Comparator: mesenchymal stem cells
bone marrow-derived mesenchymal stem cells
Biological: bone marrow-derived mesenchymal stem cells
bone marrow-derived mesenchymal stem cells

Placebo Comparator: Placebo
Drug: Placebo

Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 1 month after transfusion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01849887

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United States, California
University of California Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
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Principal Investigator: Steve Cramer, MD Univ Calif Irvine
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Responsible Party: Steven C. Cramer, MD, Professor, University of California, Irvine Identifier: NCT01849887    
Other Study ID Numbers: DR3-07521
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: January 22, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia