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

NCT ID: NCT01849887

Last Updated: 2016-01-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-01-31

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

mesenchymal stem cells

bone marrow-derived mesenchymal stem cells

Group Type: ACTIVE_COMPARATOR

bone marrow-derived mesenchymal stem cells

Intervention Type: BIOLOGICAL

bone marrow-derived mesenchymal stem cells

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

bone marrow-derived mesenchymal stem cells

bone marrow-derived mesenchymal stem cells

Intervention Type: BIOLOGICAL

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Steven C. Cramer, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steve Cramer, MD

Role: PRINCIPAL_INVESTIGATOR

Univ Calif Irvine

Locations

University of California Irvine Medical Center

Orange, California, United States

Countries

United States

Other Identifiers

DR3-07521

Identifier Type: -

Identifier Source: org_study_id