2025-520850-13-00Not yet recruitingPhase 2
StroKE34 Study Protocol: a randomized Controlled Phase IIa trial of intra-arterial Cd34+ Cells in acute ischemic Stroke
Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 30 Jan 2025
- Start date
- 1 Jul 2025
- Lead sponsor
- Unidade Local De Saude De Coimbra E.P.E.
- Diseases
- Stroke
- EU CT number
- 2025-520850-13-00
- EudraCT number
- 2017-002456-88
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 who recently had a stroke on one side of the brain, in the area supplied by the middle cerebral artery. It tests CD34+ cells given into an artery.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Acute ischemic stroke in the territory of the middle cerebral artery, with the blocked artery reopened at randomization. NIHSS score of at least 6. The scans and bone marrow collection must be possible within 7 days after the first symptoms.
- Earlier treatment
- The artery that caused the stroke must have been reopened (recanalized) at the time of randomization.
Main reasons for not taking part
- Severe narrowing (more than 70%) or blockage of the carotid artery on the same side as the stroke
- Active cancer, or surgery in the last 3 months
- Active inflammatory disease or infection, or a known clotting or platelet problem
- Known pregnancy, or any reason that rules out an MRI scan
- Pre-stroke disability (mRS score above 2), or mental impairment that prevents taking part
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Arterial dissection as cause of stroke or complication of previous angiography
- Have active malignancy, or recent surgery (within the previous 3 months)
Other illness
- 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
Lab values
- Known defect of clotting or platelet function
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Unidade Local de Saúde de Coimbra, E.P.E. | Coimbra | Portugal | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.