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Not yet taking people in PortugalPhase 2

Tests CD34+ cells given into an artery after acute ischemic stroke

Tests CD34+ cells given into an artery in adults with acute ischemic stroke.

Key facts

Who runs it
Unidade Local De Saude De Coimbra E.P.E.
Where
Coimbra, PortugalSee the site
Registry title
StroKE34 Study Protocol: a randomized Controlled Phase IIa trial of intra-arterial Cd34+ Cells in acute ischemic Stroke
Status
Not yet recruiting
Phase
Phase 2
People taking part
30 people, planned
Started
1 Jul 2025
Planned end
30 Jun 2026
Type of study
Interventional
Record updated
30 January 2025

Who can take part

AI summary

From the trial's eligibility criteria. 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

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Portugal

  • Unidade Local de Saúde de Coimbra, E.P.E.Coimbra, PortugalNot yet recruiting

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
StroKE34 Study Protocol: a randomized Controlled Phase IIa trial of intra-arterial Cd34+ Cells in acute ischemic Stroke
Plain-language title
Tests CD34+ cells given into an artery after acute ischemic strokeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
30 January 2025