acute ischemic stroke MedDRA version: 14.1 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Allogeneic eASCs
Product Code: Cx611
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Allogeneic eASCs
Current Sponsor code: Cx611
Other descriptive name: Allogeneic eA
Sponsors
FIBHULP
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of treatment with allogeneic stem cells from human adipose tissue in patients with acute ischemic stroke;Secondary Objective: 1.-To analyze the potential effectiveness of treatment with allogeneic stem cells from human adipose tissue in patients with acute ischemic stroke using the following parameters: a) Recuperación a los 3 meses mediante la evaluación de las diferencias en la escala de Rankin modificada (mRS) y en la escala de ictus NIH b) total volume of stroke by performing MRI. 2.- To identify changes in biochemical markers of brain repair as VEGF, BDNF, MMP-9 and its relationship to neurological and functional outcomes.;Primary end point(s): Safety. The safety of mesenchymal stem cells from adipose tissue will be assessed using the following parameters - Adverse events (AEs) reported spontaneously or in response to questions not addressed. Serious adverse events (SAES). These will be recorded in each visit during all the study period. - Neurological and systemic complications: deteriorating stroke, stroke recurrences, brain oedema, seizures, hemorrhagic transformation, respiratory infections, urinary tract infections, deep venous thrombosis, pulmonary embolism, gastrointestinal haemorrhage. These will be recorded in each visit during all the study period.;Timepoint(s) of evaluation of this end point: It will be evaluate at each visit during all the study period: (V0) screening; (V1) baseline; (V2) 2-hours after study drug administration; (V3) 24 hours, (V4) day 7 or hospital discharge and (V5) 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Efficacy: - Modified Rankin Scale (mRS): It will be measured at day 7 and at month 3. - Barthel Index: It will be measured at day 7 and at month 3. - NIH Stroke Scale: It will be measured at all the scheduled visits. (V0) screening; (V1) baseline; (V2) 2-hours after study drug administration; (V3) 24 hours, (V4) day 7 or hospital discharge and (V5) 3 months. - Infarct Size: It will be measured at day 7 and at month 3. - Biochemical markers of brain repair:They will be measured at baseline, day 7 and month 3.;Secondary end point(s): Efficacy: - Modified Rankin Scale (mRS): success is considered positive (patients with no or minimal disability) when the patient obtains a score of 0 or 1, and failure, when you get a score of 2 to 6. - NIH Stroke Scale: success is considered positive (patients without neurological deficit or with minimal deficit) when the patient has a total score of the NIH stroke scale of 0 to 1, and failure, when the score is between 2 and 42. - Infarct Size: indicates the total volume of infarction in neuroimaging (MRI) at day 7 and at 3 months. - Biochemical markers of brain repair: VEGF, BDNF, MMP-9. | — |
Countries
Spain
Contacts
Public ContactUCICEC
UCICEC LA PAZ
Outcome results
None listed