Single Center Pilot Clinical Trial on cell therapy in acute ictus

• Conditions: acute ischemic stroke; MedDRA version: 14.1Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-003551-18-ES
• Lead Sponsor: FIBHULP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-07
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female acute ischemic patients aged 60-80 years
2. Patients should be treated within 2 weeks from stroke onset. If the time of onset is unknown, use the time when the patient was last known to be well.
3. Patients with a measurable focal neurological deficit for at least 60 minutes. This deficit must persist from the beginning to the time of treatment without clinically meaningful improvement.
4. Patients must have computerized tomography (CT) and / or magnetic resonance imaging (MRI) compatible with the clinical diagnosis of acute ischemic stroke in the territory of the middle cerebral artery before being included in the study.
5. Patients must have a score on the NIH Stroke Scale 8-20, with at least 2 of these points in Sections 5 and 6 (motor deficit) at the time of inclusion.
6. Immediately (i.e. few minutes) before the stroke, patients should have a score on the mRS ? 1 (no symptoms at all or no significant disability despite symptoms, able to perform everyday tasks and activities).
7. Women of childbearing age should have a negative pregnancy test performed prior to inclusion.
8. Obtaining informed consent signed (after a detailed explanation of the nature and purpose of this study, the patient or guardian or legal representative must give their consent to participate by signing the informed consent document). Assent from a relative or career if the patient is unable to give meaningful consent (e.g. in cases of dysphasia, confusion, or reduced conscious level).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Comatose patients. Patients with a score of 2 or more in paragraphs related to the degree of awareness of the scale of the NIH stroke (1a).
2. Evidence on neuroimaging (CT or MRI) of brain tumour, cerebral oedema with midline shift and compression clinically significant ventricles, cerebellar infarction or brainstem, or intraventricular haemorrhage and / or intracerebral or subarachnoid.
3. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Pre-existing dementia, if it involves disability rated a score of 2 or more in the mRS.
4. Active infection, including patients with HIV, hepatic B, hepatic C, etc.
5. pre-existing dementia
6. Specify health status or any clinical conditions (e.g., life expectancy, co-existing disease) or other characteristics that precludes appropriate diagnosis, treatment or follow-up in the trial.
7. Patients who are participating in another clinical trial.
8. Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified