Overview

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