StroKE34 Study Protocol: a randomized Controlled Phase IIa trial of intra-arterial Cd34+ Cells in acute ischemic Stroke
Key facts
- Where
- Coimbra, PortugáliaSee the site
- Phase
- 2. fázis
Where in Portugália
- Unidade Local de Saúde de Coimbra, E.P.E.Coimbra, PortugáliaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Unidade Local De Saude De Coimbra E.P.E.
- Trial code
- EU 2025-520850-13-00
- Record updated
- 2025. január 30.
- Original description
To evaluate the effect of CD34+ cells administered intra-arterially in the three months infarct volume of patients with acute ischemic stroke in early (7 days) or late (20 days) subacute stage.Read full original descriptionShow less
To evaluate the effect of CD34+ cells administered intra-arterially in the three months infarct volume of patients with acute ischemic stroke in early (7 days) or late (20 days) subacute stage.
Inclusion: Age 18-80 years; Have suffered an acute hemispheric ischemic stroke attributable to injury within the territory supplied by the Middle Cerebral Artery (MCA); Symptomatic arterial territory is recanalyzed at the time of randomization; 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; Have readily accessible peripheral venous access blood sampling; 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; NIHSS of at least 6 at the time of study inclusion.
Exclusion: Arterial dissection as cause of stroke or complication of previous angiography; Have active malignancy, or recent surgery (within the previous 3 months); 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; 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; Hematological causes of stroke; Presence of high-grade (>70%) internal carotid artery stenosis or occlusion ipsilateral to the current stroke; Have inflammatory disease at baseline (chronic systemic inflammatory disease active at the time of inclusion or acute inflammatory disease such as an infection); Have severe co-existing diseases that may interfere with the conduct of the study, irrespective of stroke outcome; Allergy to contrast agents; Known defect of clotting or platelet function; Have premorbid neurological deficits and functional limitations assessed by a premorbid Modified Rankin Scale (mRS) score >2; 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); Contra-indication to MRI.