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StroKE34 Study Protocol: a randomized Controlled Phase IIa trial of intra-arterial Cd34+ Cells in acute ischemic Stroke
EU CTIS ID: 2025-520850-13-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
- Arterial dissection as cause of stroke or complication of previous angiography
- Known defect of clotting or platelet function
- Presence of high-grade (>70%) internal carotid artery stenosis or occlusion ipsilateral to the current stroke
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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
- Arterial dissection as cause of stroke or complication of previous angiography
- Known defect of clotting or platelet function
- 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 active malignancy, or recent surgery (within the previous 3 months)
- Have premorbid neurological deficits and functional limitations assessed by a premorbid Modified Rankin Scale (mRS) score >2
- Have severe co-existing diseases that may interfere with the conduct of the study, irrespective of stroke outcome
- 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
- Allergy to contrast agents
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.