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Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00859014
First Posted: March 10, 2009
Last Update Posted: January 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Sean Savitz, The University of Texas Health Science Center, Houston
  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
Ischemic Stroke Biological: Autologous Bone Marrow Mononuclear Cells Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients

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

Primary Outcome Measures:
  • Study Related Serious Adverse Events (SR-SAE) [ Time Frame: 2 Years ]
    Study Related Serious Adverse Events (SAE) as adjudicated by the DSMB - "Events"


Secondary Outcome Measures:
  • Functional Outcome [ Time Frame: 90-days ]
    Modified Rankin Scale (mRS) Score. The mRS is a six point (scored: 0 - 5) scale that measures post stroke disability. A seventh category (mRS = 6) is for patients who have died. A higher score indicates greater degree of disability. Patients scoring '5' are bed ridden, where as those scoring '0' are completely symptom free and independent.


Enrollment: 25
Study Start Date: January 2009
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous Bone Marrow Mononuclear Cells
Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
Biological: Autologous Bone Marrow Mononuclear Cells
Harvest of bone marrow from ischemic stroke patients, isolation of bone marrow mono-nuclear cells, and peripheral IV infusion of autologous bone marrow mono-nuclear cells

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 83 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. acute ischemic stroke
  2. age 18 to 83 years If >80 then the pre-stroke mRS needs to be < 1)
  3. Right hemisphere NIHSS 6 -15, left hemisphere NIHSS 6-18
  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 is allowed

Exclusion Criteria:

  1. NIHSS 1a > 1
  2. pre-stroke mRS > 1 if > 80 years of age
  3. Ischemic stroke in the last 3 months, any vascular territory
  4. 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.
  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 >1.6 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. Active malignancy or diagnosis of malignancy within 5 years prior to the start of screening or any history of chemotherapy or radiation affecting the bone marrow. Skin cancers (except for melanoma) are permitted.
  12. prior immunosuppression, including chemotherapy administration within last 3 years or current immunosuppression as defined by WBC <3 x 103 cells/ml
  13. known HIV
  14. hemoglobin <10g/dl
  15. uncorrected coagulopathy at the time of consent defined as INR >1.4; PTT>37 sec, or thrombocytopenia (PLT<100,000)
  16. any hemodynamic instability at the time of consent (e.g, requiring continuous fluid resuscitation or ionotropic support).
  17. Hypoxemia (SaO2<90%) at the time of consent, respiratory distress or persistent hypoxemia defined as SaO2 <94% for >30 minutes occurring at any time from hospital admission to time of consent. Intubation alone is not an exclusion.
  18. pregnancy or positive b-HCG
  19. current participation in any interventional research study
  20. unable to return for follow-up visits for clinical evaluation, laboratory studies, or imaging evaluation
  21. Multiple anti-platelet medications (Aggrenox is considered a single platelet agent)
  22. Unable to undergo MRI or CT scan
  23. Any other condition that the investigator feels would pose a significant hazard to the patient if enrolled.
  24. Exclude infarct lesion size >145cc unless the NIHSS 1a remains < 1 and there is no evidence of infarct expansion or edema formation on any imaging obtained from admission up to the point just prior to infusion.
  25. Exclude IA therapy use or if there is a planned or anticipated hemicraniectomy. Diagnostic angiograms are allowed
  26. CT and/or Multimodal MRI exclusion criteria will be:

    • hemispheric strokes < 1.5 cm maximum diameter (on the MRI as seen on the diffusion-weighted imaging or CT)
    • midline shift >1mm or significant hemorrhagic transformation of the acute infarct
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00859014


Locations
United States, Texas
Memorial Hermann Hospital-Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Sean I Savitz, MD University of Texas Heath Science Center- Houston
  More Information

Publications:
Responsible Party: Sean Savitz, Professor, Neurology, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00859014     History of Changes
Other Study ID Numbers: N01-HB-37163-05
R21HD060978 ( U.S. NIH Grant/Contract )
First Submitted: March 9, 2009
First Posted: March 10, 2009
Results First Submitted: December 18, 2014
Results First Posted: January 1, 2015
Last Update Posted: January 1, 2015
Last Verified: December 2014

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