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

Phase 1

Withdrawn

• Conditions: Ischemic Stroke
• Interventions: Drug: Placebo; Biological: bone marrow-derived mesenchymal stem cells

• Registration Number: NCT01849887
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-06
• Study First Submitted QC: 2013-05-08
• Study First Posted: 2013-05-09
• Status Verified: 2016-01
• Study Start: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
mesenchymal stem cells	bone marrow-derived mesenchymal stem cells	bone marrow-derived mesenchymal stem cells

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	1 month after transfusion

Trial Locations

Locations (1)

University of California Irvine Medical Center; 🇺🇸 Orange, California, United States