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Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients
This study is currently recruiting participants.
Verified by The University of Texas Health Science Center, Houston, July 2009
First Received: March 9, 2009   Last Updated: July 28, 2009   History of Changes
Sponsored by: The University of Texas Health Science Center, Houston
Information provided by: The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00859014
  Purpose

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.


Condition Intervention Phase
Acute Ischemic Stroke
Biological: Autologous stem cell
Phase I

Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Safety and feasibility of bone marrow mononuclear cell autologous (stem cell) transplantation in patients with acute stroke [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Functional outcome [ Time Frame: 90-days ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: January 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Biological: Autologous stem cell
Peripheral IV infusion of autologous stem cell

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. acute ischemic stroke in the MCA circulation, Multimodal MRI inclusion criteria will be:

    • hemispheric strokes > 2.5 cm maximum diameter on diffusion-weighted imaging
    • without midline shift or hemorrhagic transformation
    • infarct size less than or equal to 100 cc.
  2. age 18 to 80 years
  3. NIHSS 6 to 20
  4. known onset time of acute symptoms
  5. stem cell transplantation procedure must be performed within 24 to 72 hrs after stroke symptom onset
  6. TPA infusion allowed

Exclusion Criteria:

  1. experimental therapies during current hospitalization, e.g. intra-arterial or endovascular therapies
  2. ischemic stroke in the past 3 months, any vascular territory
  3. myocardial infarction in the past 3 months
  4. any prior hemorrhagic or traumatic lesion of the brain on MRI.
  5. seizure disorder
  6. developmental delay
  7. chronic kidney disease defined as baseline creatinine >1.4
  8. hepatic disease or altered liver function as defined by SGPT >150 U/L and or T. Bilirubin >1.3 mg/dL at admission
  9. pulmonary disease (e.g, COPD with oxygen-requirement at rest or with ambulation, moderate to severe asthma)
  10. mechanical heart valve
  11. any history of cancer
  12. prior immunosuppression, including prior chemotherapy administration or current immunosuppression as defined by WBC <3 x 103 cells/ml
  13. known HIV
  14. hematocrit <10g/dl
  15. uncorrected coagulopathy at the time of consent defined as INR >1.4; PTT>35 sec, or thrombocytopenia (PLT<100,000)
  16. any hemodynamic instability at the time of consent (e.g, requiring continuous fluid resuscitation or ionotropic support), or hypoxemia (SaO2<90%)
  17. persistent hypoxemia defined as SaO2 <94% for >30 minutes occurring at any time from hospital admission to time of consent
  18. pregnancy or positive b-HCG
  19. current participation in any formal research study
  20. unable to return for follow-up visits for clinical evaluation, laboratory studies, or MRI evaluation
  21. multiple anti-platelet medications (Aggrenox® is considered a single platelet agent.)
  22. history of a transient ischemic attack (TIA) in another vascular area. TIA is defined as history of a transient episode of aphasia, limb weakness, or visual loss
  23. unable to undergo MRI scan due to metal implant, claustrophobia refractory to anti-anxiety medication, weight greater than 300 pounds, or maximum circumference of 22.5 inches.
  24. any other condition that the investigator feels would pose a significant hazard to the patient if enrolled.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00859014

Contacts
Contact: Debora L East, RN, BS, BA, CCRC 713-500-5141 Debora.East@uth.tmc.edu

Locations
United States, Texas
Memorial Hermann Hospital-Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Debora East, RN, BS, BA, CCRC     713-500-5141     Debora.East@uth.tmc.edu    
Contact: Mary Hess, RN/BSN     713-500-7078     mary.jane.hess@uth.tmc.edu    
Principal Investigator: Sean I. Savitz, MD            
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Sean I. Savitz, M.D. University of Texas Heath Science Center- Houston
  More Information

No publications provided

Responsible Party: The University of Texas Health Science Center, Houston ( Sean Savitz, M.D. )
Study ID Numbers: N01-HB-37163-05
Study First Received: March 9, 2009
Last Updated: July 28, 2009
ClinicalTrials.gov Identifier: NCT00859014     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases
Cerebrovascular Disorders

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

ClinicalTrials.gov processed this record on September 11, 2009