Clinical trial NCT00908856: Autologous Cell Therapy After Stroke
Official title: Safety of IV Autologous Mononuclear Cells and Marrow Stromal Cells After Stroke
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Stroke
Keywords: stroke cell therapy repair autologous
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
First posted: 2009-05-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: death
timeFrame: 90 days after stroke onset
Secondary outcomes:
measure: myocardial infarction
timeFrame: 90 days after stroke onset
measure: pulmonary embolism
timeFrame: 90 days after stroke onset
measure: ischemic stroke
timeFrame: 90 days after stroke onset
measure: deep venous thrombosis
timeFrame: 90 days after stroke onset
measure: other arterial or venous thrombosis
timeFrame: 90 days after stroke onset
measure: Infection requiring IV antibiotics
timeFrame: 90 days after stroke onset
Other outcomes:
Locations:
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Steven C. Cramer, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References:
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.