Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
NCT ID:
NCT02178657
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02178657
Study Brief:
Protocol Section:
NCT02178657