Acute ischemic stroke MedDRA version: 21.1 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Autotransplant of CD34+ cells
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: AUTOLOGOUS CD34+ CELLS
Other descriptive name: AUTOLOGOUS CD34+ CELLS
Concentration unit: U
Sponsors
CENTRO HOSPITALAR E UNIVERSITÁRIO DE COIMBRA, E.P.E
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 18-80 years; • Acute hemispheric ischemic stroke attributable to injury within the territory supplied by the Middle Cerebral Artery; • Symptomatic arterial territory is recanalyzed; • Onset of an acute ischemic stroke that can have full clinical, imagiological and bone marrow collection within seven days after onset. Onset is defined as the time that the subject was last seen in a normal state, or bedtime for unwitnessed strokes occurring during sleep; • Readily accessible peripheral venous access blood sampling; • Ability to understand the requirements of the study and be willing to provide written informed consent, as evidenced by signature on an informed consent document, agreeing to perform the required assessments. In the event of incapacitated subjects, informed consent will be sought from a legally acceptable representative. 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: • Patients found delirious, comatose, demented or having any mental impairment that in the investigator’s opinion renders the subject incapable to participate in the study; • Neurological or non-neurological comorbidities that in the investigator’s opinion may lead, independent of the current stroke, to further deterioration in the subject’s neurological status during the trial period, or may render the study’s neurological assessments inconclusive for the purpose of evaluating solely the stroke’s effects; • Presence of high-grade (>70%) internal carotid artery stenosis or occlusion ipsilateral to the current stroke • Chronic or active acute inflammatory disease at baseline; • Active malignancy, or recent surgery (within the previous 3 months); • Premorbid neurological deficits and functional limitations assessed by a premorbid Modified Rankin Scale (mRS) score >2; • Premorbid severe hepatic, renal or hematologic diseases; • Known pregnancy. Females of childbearing potential will be screened at baseline with urine pregnancy test and positive results will be excluded (the choice of excluding pregnancies is due to the relative contra-indication to MRI in these patients); • Contra-indication to MRI. • Allergy to contrast agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial will be to assess the efficacy of intra-arterial administration of CD34+ cells at two timepoints after acute ischemic stroke. Primary outcome will be infarct volume in MRI performed at 3 months. ;Secondary Objective: The secondary objectives will include adverse events and multidimensional functional and neurological measures.;Primary end point(s): Ischemic stroke volume on MRI performed at three months;Timepoint(s) of evaluation of this end point: Three months after stroke onset. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Hemorrhagic transformation (defined as type 2 parenchymal hemorrhage) • Any stroke (ischemic stroke, intracerebral hemorrhage and subarachnoid hemorrahge) • Death of any cause • Functional outcome at three months: modified Rankin Scale (mRS) • Impact of stroke throughout the first three months: Stroke Impact Scale (SIS) • Cognitive performance at three months: Montreal Cognitive Assessment scale (MoCA) • Functional Independence at three months: Barthel Scale • Upper limb Capacity at three months: Stroke Upper Limb Capacity Scale (SULCS) • Mood at three months: Hospital Anxiety and Depression Scale (HADS) • Quality of life at three months: EuroQol Scale (EQ-5D) • Gait speed at three months (10 meters test) • Temporo-spacial gait organization at three months (GAITRIte speed) • Deglutition at three months: Functional Oral Intake Scale (FOIS) • Language: Aphasia Rapid Test (ART);Timepoint(s) of evaluation of this end point: Three months after stroke onset. | — |
Countries
Portugal
Contacts
Public ContactJoão Sargento Freitas
Centro Hospitalar e Universitário de Coimbra
Outcome results
None listed