Intra-arterial Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke


Phase 2 Results N/A

Eligibility Criteria

Inclusion Criteria

- Patients with middle cerebral artery (MCA) acute ischemic stroke.
- Time of stroke onset is known and treatment can be started between day 1 and 7 of onset.
- DWI-MRI has reliably shown acute MCA ischemic lesions
- Magnetic resonance angiography (MRA) must confirm ipsilateral MCA permeability
- National Institute of Health Stroke Scale score of 6-20 at inclusion
- Age 18-80 years
- Written informed consent has been obtained

Exclusion Criteria

- Hemorrhagic stroke or symptomatic hemorrhagic transformation
- Lacunar infarction
- Preocclusive stenosis or total occlusion of ipsilateral carotid artery
- Worsening of ≥4 points in National Institute of Health Stroke Scale in the 24 hours previous to inclusion, attributable to edema or hemorrhagic transformation or suspicious of malignant edema
- Decrease of consciousness with a Glasgow Coma Scale of <8 points
- Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma
- Contraindication for MRI or for bone marrow harvest
- Previous diagnosis of neurodegenerative disease
- Acute heart failure
- Hepatic or renal dysfunction (creatinine >2mg/dL)
- Coagulopathy
- Severe co-morbidity
- Pregnancy, childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding
- Modified Rankin Score (mRS) before stroke of ≥2
- Participation in any clinical trial in the last 3 months