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

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
• •* 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