NCT01849887

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2013

Completed
2.6 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 22, 2016

Status Verified

January 1, 2016

Enrollment Period

Same day

First QC Date

May 6, 2013

Last Update Submit

January 20, 2016

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events

    1 month after transfusion

Study Arms (2)

mesenchymal stem cells

ACTIVE COMPARATOR

bone marrow-derived mesenchymal stem cells

Biological: bone marrow-derived mesenchymal stem cells

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

bone marrow-derived mesenchymal stem cellsBIOLOGICAL

bone marrow-derived mesenchymal stem cells

mesenchymal stem cells
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.
  • \. 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.
  • \. Age 18-80 years, inclusive
  • \. Reasonable likelihood of receiving standard post-stroke medical care, as well as standard physical, occupational, and speech therapy.

You may not qualify if:

  • \. No substantial pre-stroke disability (pre-stroke modified Rankin Scale score 0-2).
  • \. 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.
  • \. Lactating mothers
  • \. If thrombolytic therapy has been administered, at least 24 hours have passed between completing thrombolytic dosing and initiating the current study's transfusion.
  • \. Known allergy to penicillin or to fetal bovine serum
  • \. Active co-existent major neurological or psychiatric disease that could significantly interfere with patient compliance or study assessments, including drug or alcohol abuse.
  • \. Any diagnosis that makes survival to 1-year post-stroke unlikely.
  • \. Participation in any other experimental therapeutic clinical trial concurrently or in the prior three months.
  • \. Contraindication to undergoing MRI scanning.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Steve Cramer, MD

    Univ Calif Irvine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 6, 2013

First Posted

May 9, 2013

Study Start

January 1, 2016

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 22, 2016

Record last verified: 2016-01

Locations

US(1)