In short
Clinical trials are 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. The trial aims to see whether this treatment can affect recovery, especially infarct volume after stroke, and it is being tested in a phase 2 study in adults with acute ischemic stroke.
Key points
- Clinical trials are studying AUTOLOGOUS CD34+ ENRICHED CELL FRACTION THAT CONTAINS CD34+ CELLS TRANSDUCED WITH RETROVIRAL VECTOR THAT ENCODES FOR THE HUMAN ADA CDNA SEQUENCE in ischemic stroke. The trial is a phase 2 interventional study and is authorised. It is focused on adults with acute ischemic stroke in the early subacute stage or late subacute stage. The main outcome is infarct volume at three months after stroke. The planned enrollment is 30 participants.
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. The study is described as a randomized controlled phase IIa trial and is authorised.
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.
Who is being studied
The target population is patients with acute ischemic stroke. 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.
This means the trial is not for all stroke patients, but for people in a specific recovery window after the stroke event.
Study design and phase
The study type is interventional, which means the researchers give a treatment and then measure the results. 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.
The title describes it as a randomized controlled Phase IIa trial. Randomized means people are assigned by chance to study groups, which helps make the comparison fair.
What is being measured
The primary outcome is infarct volume at three months after ischemic stroke. Infarct volume means the size of the brain area damaged by the stroke.
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.
Trial status and enrollment
The trial status is Authorised. The planned enrollment is 30 participants.
This is a small study, which is common in early phase research.