Autologous Cell Therapy After Stroke

February 2, 2016 updated by: Steven C. Cramer, MD, University of California, Irvine

Safety of IV Autologous Mononuclear Cells and Marrow Stromal Cells After Stroke

This study will examine the safety of two different cellular therapies in the treatment of stroke.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Stroke remains a leading cause of death and disability. A limited number of therapies, such as intravenous tissue plasminogen activator, have been approved to interrupt stroke in the early hours after symptom onset. Many patients are not able to benefit from these therapies, however, and so a need exists for development of new interventions to reduce disability after stroke. This study will be an early step towards this, and will examine the safety of two cell types, mononuclear cells and marrow stromal cells. In each case, the cells will be autologous, specifically being derived from the subject's own bone marrow.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • UC Irvine Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
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
Active Comparator: autologous mononuclear cells
a single intravenous autologous bone marrow mononuclear cell transfusion
Biological: autologous bone marrow mononuclear cell transfusion
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
Other Names:
  • mononuclear cells
Active Comparator: autologous marrow stromal cells
a single intravenous autologous marrow stromal cell transfusion
Biological: marrow stromal cells
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)
Other Names:
  • mesenchymal stromal cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
death
Time Frame: 90 days after stroke onset
90 days after stroke onset

Secondary Outcome Measures

Outcome Measure
Time Frame
myocardial infarction
Time Frame: 90 days after stroke onset
90 days after stroke onset
pulmonary embolism
Time Frame: 90 days after stroke onset
90 days after stroke onset
ischemic stroke
Time Frame: 90 days after stroke onset
90 days after stroke onset
deep venous thrombosis
Time Frame: 90 days after stroke onset
90 days after stroke onset
other arterial or venous thrombosis
Time Frame: 90 days after stroke onset
90 days after stroke onset
Infection requiring IV antibiotics
Time Frame: 90 days after stroke onset
90 days after stroke onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

University of California, San Diego

Investigators

  • Principal Investigator: Steven C. Cramer, MD, MMSc, University of California, Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

May 26, 2009

First Submitted That Met QC Criteria

May 26, 2009

First Posted (Estimate)

May 27, 2009

Study Record Updates

Last Update Posted (Estimate)

February 4, 2016

Last Update Submitted That Met QC Criteria

February 2, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003-3040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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