EUCTR2011-001393-26-ES
Active, not recruiting
Not Applicable
Phase II clinical trial to evaluate the feasibility and safety of human adipose derived mesenchymal stem cells on chronic ischaemic stroke. - Celictus study
Fundación para la Investigación Biomédica del Hospital Clínico San Carlos0 sitesMarch 29, 2012
DrugsTissucol Duo 5,0
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fundación para la Investigación Biomédica del Hospital Clínico San Carlos
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Capacity for sign and understand the informed consent form
- •2\. Age between 25 and 70 years old in the inclusion time
- •3\. Man or woman with middle cerebral artery ischemic stroke at least in the 6 months prior to the inclusion
- •4\. Image techniques showing injuries consistent with complete infarction of middle cerebral artery
- •5\. Patients with severe secuelae verified by a 2 Rankin test level or less
- •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 14
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •1\. Patients requiring tracheostomy or non\-invasive ventilation for more than 16 hours a day.
- •2\. Presence of multiple lacunar infarcts in CT scan or MRI
- •3\. History of intracranial hemorrhage or subarachnoid hemorrhage.
- •4\. Patients who have used antipsychotics at therapeutic doses in the month prior to inclusion.
- •5\. History of cancer in the three years prior to inclusion.
- •6\. Previous ideas of suicide
- •7\. Patients with known history of alcohol or drugs.
- •8\. Patients with a history of heart disease, renal, hepatic, systemic, immune, that can influence patient survival during the test control.
- •9\. Patients with chronic neurological disease like Parkinson's, tremor, neurodegenerative disease, etc. ..
- •10\. History of uncontrolled hypertension.
Outcomes
Primary Outcomes
Not specified
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