Table of contents
- Trial overview
- Who is being studied
- Study design and phase
- What the trial measures
- Trial status and size
Trial overview
The available study is titled StroKE34 Study Protocol and it is a randomized controlled Phase IIa trial of intra-arterial CD34+ cells in acute ischemic stroke.[1] The trial is authorised and studies people with ischemic stroke.[1]
The intervention listed in the trial data is AUTOLOGOUS CD34+ ENRICHED CELL FRACTION THAT CONTAINS CD34+ CELLS TRANSDUCED WITH RETROVIRAL VECTOR THAT ENCODES FOR THE HUMAN ADA CDNA SEQUENCE, shown in the source as Strimvelis 1-10 x 10^6 cells/mL dispersion for infusion.[1] The trial brief summary says the study is evaluating the effect of CD34+ cells given intra-arterially on infarct volume after stroke.[1]
Who is being studied
The target population is people with acute ischemic stroke.[1] The brief summary says the study includes patients in an early subacute stage, about 7 days after stroke, or a later subacute stage, about 20 days after stroke.[1]
This means the trial is not for all stroke patients, but for a specific time window after the stroke event.[1] In simple terms, the researchers are studying whether treatment soon after stroke may help limit the later size of the brain injury.[1]
Study design and phase
This is an interventional study, which means the research team gives a treatment and then measures what happens.[1] It is also described as a randomized controlled trial, meaning participants are assigned by chance and compared in a controlled way.[1]
The study phase is Phase 2.[1] Phase 2 trials usually look for early signs that a treatment may work, while also continuing to follow safety and study design questions.[1]
The intervention is described as being given intra-arterially, which means into an artery, a blood vessel that carries blood away from the heart.[1] The trial data also lists an intravenous infusion form in the intervention field, but the brief summary specifically says the cells are administered intra-arterially.[1]
What the trial measures
The main outcome is infarct volume at three months after ischemic stroke.[1] Infarct volume means the size of the damaged area in the brain after the stroke.[1]
This outcome helps researchers see whether the treatment may reduce the amount of brain injury over time.[1] The trial data does not list additional outcomes, so the main focus in the available source is the three-month infarct volume.[1]
Trial status and size
The study status is Authorised.[1] The planned enrollment is 30 participants, which makes this a small clinical study.[1]
Because the trial is small and in Phase 2, it is designed to give early information about whether the approach should be studied further in stroke care.[1]
