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

Inclusion Criteria

• acute ischemic stroke
• age 18 to 83 years If >80 then the pre-stroke mRS needs to be 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
• 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.
• prior immunosuppression, including chemotherapy administration within last 3 years or current immunosuppression as defined by WBC 1.4; PTT>37 sec, or thrombocytopenia (PLT 30 minutes occurring at any time from hospital admission to time of consent. Intubation alone is not an exclusion.
• pregnancy or positive b-HCG
• current participation in any interventional research study
• unable to return for follow-up visits for clinical evaluation, laboratory studies, or imaging evaluation
• Multiple anti-platelet medications (Aggrenox is considered a single platelet agent)
• Unable to undergo MRI or CT scan
• Any other condition that the investigator feels would pose a significant hazard to the patient if enrolled.
• Exclude infarct lesion size >145cc unless the NIHSS 1a remains 1mm or significant hemorrhagic transformation of the acute infarct