Neovascularization Induced by Mechanical Barrier disrUption and Systemic Erythropoietin in Patients With Cerebral Perfusion Deficits "NIMBUS"

Not yet recruiting

Phase 2 Results N/A

Eligibility Criteria

Inclusion Criteria

- Acute period (ischemic stroke confirmation on DWI or TIA within 7 days after symptom onset)
- Below 20 point of initial NIHSS score within 7 days after stroke onset and enrolment.
- Confirmation of atherosclerotic or steno-occlusive stroke mechanism (proximal cerebral arteries) on CTA or MRA .
- At least hemodynamically, perfusion status of a candidate is stage II or III (decrease of regional Cerebral blood flow on CBF map)
- If female then not of childbearing potential
- Informed consent

Exclusion Criteria

- Primary intracerebral haemorrhage (ICH), or parenchymal haemorrhagic transformation of infarction (type PHI or PHII as defined in ECASS), subarachnoid haemorrhage (SAH), arterio-venous malformation (AVM), cerebral aneurysm, or cerebral neoplasm
- Treated with a thrombolytic <24 hours (if >24 hours and excluded ICH then eligible)
- Score >=1 on the NIHSS item 1a
- Pre-stroke mRS score >=2
- Uncontrolled hypertension
- Previous treatment with erythropoietin
- At screening: Hemoglobin >15 mg/dl, prolonged PT or PTT, serum Cr >2.0 mg/dl,thrombocytopenia or neutropenia as defined by the lower limit of normal for the platelet count or white blood cell count, respectively (absolute neutrophil count of > 1800/mm3 required for participation), or > 2 times of normal on liver function tests (SGOT, SGPT, total bilirubin)