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

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ClinicalTrials.gov Identifier: NCT00859014
Recruitment Status : Completed
First Posted : March 10, 2009
Results First Posted : January 1, 2015
Last Update Posted : January 1, 2015
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE March 9, 2009
First Posted Date  ICMJE March 10, 2009
Results First Submitted Date  ICMJE December 18, 2014
Results First Posted Date  ICMJE January 1, 2015
Last Update Posted Date January 1, 2015
Study Start Date  ICMJE January 2009
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2014)
Study Related Serious Adverse Events (SR-SAE) [ Time Frame: 2 Years ]
Study Related Serious Adverse Events (SAE) as adjudicated by the DSMB - "Events"
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2009)
Safety and feasibility of bone marrow mononuclear cell autologous (stem cell) transplantation in patients with acute stroke [ Time Frame: 5 years ]
Change History Complete list of historical versions of study NCT00859014 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2014)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2009)
Functional Outcome [ Time Frame: 90-days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients
Official Title  ICMJE Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Stroke
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Biological: Autologous Bone Marrow Mononuclear Cells
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2014)
25
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2009)
10
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 83 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00859014
Other Study ID Numbers  ICMJE N01-HB-37163-05
R21HD060978 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sean Savitz, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Sean I Savitz, MD University of Texas Heath Science Center- Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP