Expanded Access Multi-Patient Experimental Treatment Involving Allogeneic Human Mesenchymal Stem Cells (hMSCs) in Subjects With Acute Ischemic Stroke (EXPAND)

Exclusion Criteria

• •1. Permanent disability corresponding to a Modified Rankin Score of \>1 prior to the Qualifying Stroke Event.
• •2. Has a medical history of neurological or orthopedic pathology with a deficit as a consequence that results in a modified Rankin Scale \>1 before stroke or has a pre-existing cognitive deficit.
• •3. Ischemic stroke in the last 3 months, any vascular territory. Has clinically significant and/or symptomatic hemorrhage associated with stroke
• •4. Myocardial Infarction (MI), primary hemorrhagic or traumatic lesion of the brain within the last 3 months or identified on magnetic resonance imaging (MRI). Small hemorrhagic transformation of the acute infarct is allowed.
• •5. Seizure disorder
• •6. Developmental delay
• •7. Chronic kidney disease is defined as baseline serum creatinine \>1.4
• •8. Hepatic disease or altered liver function as defined by serum glutamate pyruvate transaminase (SGPT) \>150 U/L and or T. Bilirubin \>1.6 mg/dL at admission
• •9. Pulmonary disease (e.g., chronic obstructive pulmonary disease (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 white blood cell count (WBC) \<3 x 103 cells/ml
• •13. Hepatic insufficiency (bilirubin \>2.5mg/dL or transaminases \>5x the upper limit of normal). Patients with Gilberts syndrome are eligible for enrollment if other liver function tests are normal, regardless of bilirubin level.
• •14. Known HIV
• •15. Hemoglobin \<10g/dl
• •16. Uncorrected coagulopathy at the time of consent defined as international normalized ratio (INR) \>1.4; partial thromboplastin time (PTT) \>37 sec, or thrombocytopenia (PLT\<100,000)
• •17. Any hemodynamic instability at the time of consent (e.g., requiring continuous fluid resuscitation or ionotropic support).
• •18. 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.
• •19. Pregnancy or positive human chorionic gonadotropin (HCG) or lactating women
• •20. Subjects participating in another interventional clinical trial of an investigational therapy within 30 days of screening
• •21. Unable to return for follow-up visits for clinical evaluation, laboratory studies, or imaging evaluation
• •22. Multiple anti-platelet medications (Aggrenox is considered a single platelet agent)
• •23. Unable to undergo MRI or CT scan
• •24. Any other condition that the investigator feels would pose a significant hazard to the patient if enrolled.
• •25. 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.
• •26. Exclude Intra Arterial (IA) therapy use or if there is a planned or anticipated hemicraniectomy. Diagnostic angiograms are allowed