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Autologous Cell Therapy After Stroke

This study has been withdrawn prior to enrollment.
(Not funded)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00908856
First Posted: May 27, 2009
Last Update Posted: February 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Steven C. Cramer, MD, University of California, Irvine
  Purpose
This study will examine the safety of two different cellular therapies in the treatment of stroke.

Condition Intervention Phase
Stroke Biological: autologous bone marrow mononuclear cell transfusion Biological: marrow stromal cells Drug: placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety of IV Autologous Mononuclear Cells and Marrow Stromal Cells After Stroke

Further study details as provided by Steven C. Cramer, MD, University of California, Irvine:

Primary Outcome Measures:
  • death [ Time Frame: 90 days after stroke onset ]

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

Enrollment: 0
Study Start Date: January 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
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 Name: 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 Name: mesenchymal stromal cells

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908856


Locations
United States, California
UC Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
University of California, San Diego
Investigators
Principal Investigator: Steven C. Cramer, MD, MMSc University of California, Irvine
  More Information

Publications:
Responsible Party: Steven C. Cramer, MD, Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00908856     History of Changes
Other Study ID Numbers: 2003-3040
First Submitted: May 26, 2009
First Posted: May 27, 2009
Last Update Posted: February 4, 2016
Last Verified: February 2016

Keywords provided by Steven C. Cramer, MD, University of California, Irvine:
stroke cell therapy repair autologous

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases