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Autologous Cell Therapy After Stroke

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by University of California, Irvine
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Steven C. Cramer, MD, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00908856
First received: May 26, 2009
Last updated: January 14, 2013
Last verified: January 2013

May 26, 2009
January 14, 2013
January 2014
December 2015   (final data collection date for primary outcome measure)
death [ Time Frame: 90 days after stroke onset ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00908856 on ClinicalTrials.gov Archive Site
  • myocardial infarction [ Time Frame: 90 days after stroke onset ] [ Designated as safety issue: Yes ]
  • pulmonary embolism [ Time Frame: 90 days after stroke onset ] [ Designated as safety issue: Yes ]
  • ischemic stroke [ Time Frame: 90 days after stroke onset ] [ Designated as safety issue: Yes ]
  • deep venous thrombosis [ Time Frame: 90 days after stroke onset ] [ Designated as safety issue: Yes ]
  • other arterial or venous thrombosis [ Time Frame: 90 days after stroke onset ] [ Designated as safety issue: Yes ]
  • Infection requiring IV antibiotics [ Time Frame: 90 days after stroke onset ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Autologous Cell Therapy After Stroke
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Stroke
  • 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
  • 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
  • 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
    Other Name: placebo
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: placebo
  • Active Comparator: autologous mononuclear cells
    a single intravenous autologous bone marrow mononuclear cell transfusion
    Intervention: Biological: autologous bone marrow mononuclear cell transfusion
  • Active Comparator: autologous marrow stromal cells
    a single intravenous autologous marrow stromal cell transfusion
    Intervention: Biological: marrow stromal cells
Lane TA, Garls D, Mackintosh E, Kohli S, Cramer SC. Liquid storage of marrow stromal cells. Transfusion. 2009 Mar 31; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
33
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Steven C. Cramer, MD, MMSc 714-456-6876 scramer@uci.edu
United States
 
NCT00908856
2003-3040
No
Steven C. Cramer, MD, University of California, Irvine
University of California, Irvine
University of California, San Diego
Principal Investigator: Steven C. Cramer, MD, MMSc University of California, Irvine
University of California, Irvine
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP