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

University of California Irvine (UCI)

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Ischemic Stroke

Treatments

Biological: bone marrow-derived mesenchymal stem cells

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01849887

DR3-07521

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.
1. 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.
1. Age 18-80 years, inclusive
1. 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).
1. 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.
1. Lactating mothers
1. If thrombolytic therapy has been administered, at least 24 hours have passed between completing thrombolytic dosing and initiating the current study's transfusion.
1. Known allergy to penicillin or to fetal bovine serum
1. Active co-existent major neurological or psychiatric disease that could significantly interfere with patient compliance or study assessments, including drug or alcohol abuse.
1. Any diagnosis that makes survival to 1-year post-stroke unlikely.
1. Participation in any other experimental therapeutic clinical trial concurrently or in the prior three months.
1. Contraindication to undergoing MRI scanning.