NCT00859014
Completed
Phase 1
Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients
The University of Texas Health Science Center, Houston1 site in 1 country25 target enrollmentJanuary 2009
ConditionsIschemic Stroke
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Ischemic Stroke
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Study Related Serious Adverse Events (SR-SAE)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this research study is to find out if bone marrow treatment (bone marrow aspiration and infusion of stem cells) can be safely used in adults who have recently (within 24-72 hours)suffered an acute ischemic stroke.
Detailed Description
Our primary hypothesis is that autologous bone marrow mononuclear cell transplantation by intravenous administration is feasible and safe after acute ischemic stroke. Our secondary hypothesis is that autologous transplantation is associated with improved outcome after acute stroke.
Investigators
Sean Savitz
Professor, Neurology
The University of Texas Health Science Center, Houston
Eligibility Criteria
Inclusion Criteria
- •acute ischemic stroke
- •age 18 to 83 years If \>80 then the pre-stroke mRS needs to be \< 1)
- •Right hemisphere NIHSS 6 -15, left hemisphere NIHSS 6-18
- •known onset time of acute symptoms
- •stem cell transplantation procedure must be performed within 24 to 72 hrs after stroke symptom onset
- •TPA infusion is allowed
Exclusion Criteria
- •NIHSS 1a \> 1
- •pre-stroke mRS \> 1 if \> 80 years of age
- •Ischemic stroke in the last 3 months, any vascular territory
- •MI, primary hemorrhagic or traumatic lesion of the brain within the last 3 months or identified on MRI. Small hemorrhagic transformation of the acute infarct is allowed.
- •seizure disorder
- •developmental delay
- •chronic kidney disease defined as baseline creatinine \>1.4
- •hepatic disease or altered liver function as defined by SGPT \>150 U/L and or T. Bilirubin \>1.6 mg/dL at admission
- •pulmonary disease (e.g, COPD with oxygen-requirement at rest or with ambulation, moderate to severe asthma)
- •mechanical heart valve
Outcomes
Primary Outcomes
Study Related Serious Adverse Events (SR-SAE)
Time Frame: 2 Years
Study Related Serious Adverse Events (SAE) as adjudicated by the DSMB - "Events"
Secondary Outcomes
- Functional Outcome(90-days)
Study Sites (1)
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