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Autologous Cell Therapy After Stroke

Primary Purpose

Stroke

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
autologous bone marrow mononuclear cell transfusion
marrow stromal cells
placebo
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke cell therapy repair autologous

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC Irvine Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

autologous mononuclear cells

autologous marrow stromal cells

Arm Description

Placebo

a single intravenous autologous bone marrow mononuclear cell transfusion

a single intravenous autologous marrow stromal cell transfusion

Outcomes

Primary Outcome Measures

death

Secondary Outcome Measures

myocardial infarction
pulmonary embolism
ischemic stroke
deep venous thrombosis
other arterial or venous thrombosis
Infection requiring IV antibiotics

Full Information

First Posted
May 26, 2009
Last Updated
February 2, 2016
Sponsor
University of California, Irvine
Collaborators
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT00908856
Brief Title
Autologous Cell Therapy After Stroke
Official Title
Safety of IV Autologous Mononuclear Cells and Marrow Stromal Cells After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Not funded
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke cell therapy repair autologous

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
autologous mononuclear cells
Arm Type
Active Comparator
Arm Description
a single intravenous autologous bone marrow mononuclear cell transfusion
Arm Title
autologous marrow stromal cells
Arm Type
Active Comparator
Arm Description
a single intravenous autologous marrow stromal cell transfusion
Intervention Type
Biological
Intervention Name(s)
autologous bone marrow mononuclear cell transfusion
Other Intervention Name(s)
mononuclear cells
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
marrow stromal cells
Other Intervention Name(s)
mesenchymal stromal cells
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
death
Time Frame
90 days after stroke onset
Secondary Outcome Measure Information:
Title
myocardial infarction
Time Frame
90 days after stroke onset
Title
pulmonary embolism
Time Frame
90 days after stroke onset
Title
ischemic stroke
Time Frame
90 days after stroke onset
Title
deep venous thrombosis
Time Frame
90 days after stroke onset
Title
other arterial or venous thrombosis
Time Frame
90 days after stroke onset
Title
Infection requiring IV antibiotics
Time Frame
90 days after stroke onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven C. Cramer, MD, MMSc
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19389020
Citation
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.
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Autologous Cell Therapy After Stroke

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