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
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety of IV Autologous Mononuclear Cells and Marrow Stromal Cells After Stroke

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • death [ Time Frame: 90 days after stroke onset ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 33
Study Start Date: January 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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
Other Name: placebo
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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908856

Contacts
Contact: Steven C. Cramer, MD, MMSc 714-456-6876 scramer@uci.edu

Locations
United States, California
UC Irvine Medical Center Not yet recruiting
Orange, California, United States, 92868
Contact: Steven C. Cramer, MD, MMSc    714-456-6876      
Principal Investigator: Steven C. Cramer, MD, MMSc         
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
Study First Received: May 26, 2009
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of California, Irvine:
stroke cell therapy repair autologous

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

ClinicalTrials.gov processed this record on October 21, 2014