Table of contents
- Trial overview
- Who is being studied
- Study design and phase
- What is being measured
- Trial status and enrollment
Trial overview
This article is about a clinical trial that is studying AUTOLOGOUS CD34+ ENRICHED CELL FRACTION THAT CONTAINS CD34+ CELLS TRANSDUCED WITH RETROVIRAL VECTOR THAT ENCODES FOR THE HUMAN ADA CDNA SEQUENCE in people with ischemic stroke.[1] The study is described as a randomized controlled phase IIa trial and is authorised.[1]
The brief summary says the study is testing whether CD34+ cells given intra-arterially can affect the three-month infarct volume after acute ischemic stroke.[1]
Who is being studied
The target population is patients with acute ischemic stroke.[1] The summary also says participants are in the early subacute stage, about 7 days after stroke, or the late subacute stage, about 20 days after stroke.[1]
This means the trial is not for all stroke patients, but for people in a specific recovery window after the stroke event.[1]
Study design and phase
The study type is interventional, which means the researchers give a treatment and then measure the results.[1] It is listed as a Phase 2 trial, which usually means the study is looking more closely at whether the treatment may help and how people respond to it.[1]
The title describes it as a randomized controlled Phase IIa trial.[1] Randomized means people are assigned by chance to study groups, which helps make the comparison fair.[1]
What is being measured
The primary outcome is infarct volume at three months after ischemic stroke.[1] Infarct volume means the size of the brain area damaged by the stroke.[1]
This outcome helps researchers see whether the study treatment is linked to a smaller or different amount of brain injury after recovery time has passed.[1]
Trial status and enrollment
The trial status is Authorised.[1] The planned enrollment is 30 participants.[1]
This is a small study, which is common in early phase research.[1]
