NCT00908856

Brief Summary

This study will examine the safety of two different cellular therapies in the treatment of 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withdrawn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 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
6.6 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

1.9 years

First QC Date

May 26, 2009

Last Update Submit

February 2, 2016

Conditions

Stroke

Keywords

stroke cell therapy repair autologous

Outcome Measures

Primary Outcomes (1)

  • death

    90 days after stroke onset

Secondary Outcomes (6)

  • myocardial infarction

    90 days after stroke onset

  • pulmonary embolism

    90 days after stroke onset

  • ischemic stroke

    90 days after stroke onset

  • deep venous thrombosis

    90 days after stroke onset

  • other arterial or venous thrombosis

    90 days after stroke onset

  • +1 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: placebo

autologous mononuclear cells

ACTIVE COMPARATOR

a single intravenous autologous bone marrow mononuclear cell transfusion

Biological: autologous bone marrow mononuclear cell transfusion

autologous marrow stromal cells

ACTIVE COMPARATOR

a single intravenous autologous marrow stromal cell transfusion

Biological: marrow stromal cells

Interventions

autologous bone marrow mononuclear cell transfusionBIOLOGICAL

a single intravenous transfusion approximately 2 days after bone marrow aspiration, and 4 days after stroke onset; the full amount of autologous mononuclear cells derived from 30 cc of bone marrow

Also known as: mononuclear cells
autologous mononuclear cells
marrow stromal cellsBIOLOGICAL

a single intravenous transfusion approximately 21 days after bone marrow aspiration, and 23 days after stroke onset; the full amount of marrow stromal cells cultured over 21 days from 30 cc of bone marrow (expected to be approximately 1,000,000 cells/kg body weight)

Also known as: mesenchymal stromal cells
autologous marrow stromal cells
placeboDRUG

a single intravenous transfusion of saline, approximately 2-21 days after bone marrow aspiration, and 4-23 days after stroke onset; the full amount of mononuclear cells derived from 30 cc of bone marrow

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ischemic stroke that is supratentorial in location and \< 72 hours old between stroke onset and bone marrow aspiration
  • No major pre-stroke disability
  • NIH stroke scale score of 7-24
  • Able to undergo bedside bone marrow aspiration
  • Age 18-85 years, inclusive
  • Reasonable likelihood of receiving standard physical, occupational and speech rehabilitation therapy

You may not qualify if:

  • No major active hematological, immunological, or oncological diagnoses
  • Pregnancy
  • Lactating mothers
  • At least 24 hours time of any thrombolytic therapy and time of bone marrow aspiration
  • Allergy to penicillin or to fetal bovine serum
  • Active, major co-existent neurological or psychiatric disease
  • Infection with HIV, hepatitis B or C, or syphilis
  • Any diagnosis that makes survival to 90 days post-stroke unlikely
  • Participation in an experimental therapeutic clinical trial in the prior three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Irvine Medical Center

Orange, California, 92868, United States

Location

Related Publications (1)

  • Lane TA, Garls D, Mackintosh E, Kohli S, Cramer SC. Liquid storage of marrow stromal cells. Transfusion. 2009 Jul;49(7):1471-81. doi: 10.1111/j.1537-2995.2009.02138.x. Epub 2009 Mar 31.

    PMID: 19389020BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

SLC25A33 protein, human

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Steven C. Cramer, MD, MMSc

    University of California, 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 26, 2009

First Posted

May 27, 2009

Study Start

January 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 4, 2016

Record last verified: 2016-02

Locations

US(1)