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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial aims to test that intra-arterial injection of autologous bone marrow mononuclear cells in acute ischemic stroke patients is safe and improves neurological outcomes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andalusian Initiative for Advanced Therapies

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