AUTOLOGOUS CD34+ ENRICHED CELL FRACTION THAT CONTAINS CD34+ CELLS TRANSDUCED WITH RETROVIRAL VECTOR THAT ENCODES FOR THE HUMAN ADA CDNA SEQUENCE for Ischemic stroke

Inclusion criteria

• {"criterion_text":"- Age 18-80 years\n- Have suffered an acute hemispheric ischemic stroke attributable to injury within the territory supplied by the Middle Cerebral Artery (MCA)\n- Symptomatic arterial territory is recanalyzed at the time of randomization\n- Onset of an acute ischemic stroke that can have full clinical, imagiological and bone marrow collection within 7 days after the onset of symptoms. Onset is defined as the time that the subject was last seen in a normal state, or bedtime for unwitnessed strokes occurring during sleep\n- Have readily accessible peripheral venous access blood sampling\n- Have the 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 (which has been submitted and approved by the local Ethical Committee),and agree to perform the required assessments. In the event of incapacitated subjects, informed consent will be sought from a legally acceptable representative\n- NIHSS of at least 6 at the time of study inclusion"}

Exclusion criteria

• {"criterion_text":"- Patients found delirious, comatose, demented or having any mental impairment other than the neurological deficits related to the index stroke that in the investigator’s opinion renders the subject incapable to participate in the study\n- Non compliance of portuguese national law 12/2009 of march 26th (including but not limited to donor laboratorial analysis not compliant with HIV 1 and 2 (anti-HIV-1,2); hepatitis B (HBsAg; anti-HBc); hepatitisC (anti-HCV-Ab); syphilis and Mycoplasm\n- Hematological causes of stroke\n- Arterial dissection as cause of stroke or complication of previous angiography\n- Known defect of clotting or platelet function\n- Presence of high-grade (>70%) internal carotid artery stenosis or occlusion ipsilateral to the current stroke\n- Have inflammatory disease at baseline (chronic systemic inflammatory disease active at the time of inclusion or acute inflammatory disease such as an infection)\n- Have active malignancy, or recent surgery (within the previous 3 months)\n- Have premorbid neurological deficits and functional limitations assessed by a premorbid Modified Rankin Scale (mRS) score >2\n- Have severe co-existing diseases that may interfere with the conduct of the study, irrespective of stroke outcome\n- Have 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)\n- Contra-indication to MRI\n- Allergy to contrast agents"}

Primary endpoints

• {"endpoint_text":"- Infarct volume at three months after ischemic stroke\n- Volume de enfarte aos três meses após AVC isquémico","definition_or_measurement_approach":"Measured as infarct volume at three months by imaging (imaging outcome; MRI contraindication is listed among exclusions)"}

Secondary endpoints

• {"endpoint_text":"- Functional outcome: modified Rankin Scale (mRS), Stroke Impact Scale (SIS)","definition_or_measurement_approach":"Measured using modified Rankin Scale (mRS) and Stroke Impact Scale (SIS)"}
• {"endpoint_text":"- Cognitive performance: Montreal Cognitive Assessment scale (MoCA)","definition_or_measurement_approach":"Measured using Montreal Cognitive Assessment (MoCA)"}
• {"endpoint_text":"- Functional Independence and performance : Barthel Scale; Upper limb Capacity - Stroke Upper Limb Capacity Scale – SULCS;\tEvaluation of gait speed (TEST 10 METERS); Evaluation of temporospacial gait (GAIT RIte speed)","definition_or_measurement_approach":"Measured using Barthel Scale, SULCS for upper limb capacity, 10-meter walk test for gait speed and GAITRite system for temporospatial gait metrics"}
• {"endpoint_text":"- Depression -\tHospital Anxiety and Depression Scale- (HADS Scale)","definition_or_measurement_approach":"Measured using Hospital Anxiety and Depression Scale (HADS)"}
• {"endpoint_text":"- Qualitiy of life assessment - EuroQol Scale( EQ-5D)","definition_or_measurement_approach":"Measured using EuroQol EQ-5D"}
• {"endpoint_text":"- Deglutition: Teste Rápido de Identificação da Disfagia (TRIDIS); Functional Oral Intake de Identificação da Disfagia (FOIS)","definition_or_measurement_approach":"Measured using TRIDIS and FOIS swallowing/deglutition assessments"}
• {"endpoint_text":"- Aphasia: Bateria de Avaliação de Afasia de Lisboa - BAAL; The Aphasia Rapid Test (ART)","definition_or_measurement_approach":"Measured using BAAL and Aphasia Rapid Test (ART)"}

Portugal

Earliest CTIS Part Ii Submission Date

27-01-2025

Latest Decision Or Authorization Date

30-01-2025

Processing Time Days

3

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Unidade Local De Saude De Coimbra E.P.E.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Portugal