Table of contents
- Trial overview
- Who is being studied
- What the study measures
- Study design and phase
- Key patient terms
Trial overview
The available trial data describe one interventional study of AUTOLOGOUS REGULATORY T-CELLS WITH AN IMMUNOPHENOTYPE OF CD4+CD25HI/+FOXP3+ in adults with ulcerative colitis.[1] The study is authorised, which means it has been approved to move forward in the setting listed in the source data.[1]
This study is a multi-center and single-arm trial, so it is being done at more than one site and all participants receive the study treatment rather than being split into comparison groups.[1] The planned enrollment is 30 people.[1]
Who is being studied
The target population is adults with ulcerative colitis.[1] No other eligibility details are provided in the source data, so the trial data do not show extra age limits, disease severity rules, or other joining criteria.
The condition being studied is ulcerative colitis, a disease that affects the bowel and can cause ongoing inflammation.[1] In this trial, the focus is on people whose disease activity can be measured with the modified Mayo score.[1]
What the study measures
The primary endpoint is the proportion of participants in clinical remission at week 12 compared with the day of screening.[1] This means the study checks how many people reach a low-symptom state after treatment.[1]
Remission is defined in the source data using the modified Mayo score.[1] The remission rule includes a rectal bleeding score of 0, a stool frequency score of 0 or 1, and an endoscopy score of 0 or 1, with friability excluded.[1]
The brief summary also says the study aims to evaluate the rate of clinical remission at week 12, which matches the primary endpoint.[1] The title adds that the study also looks at efficacy and in-vivo homing, meaning how well the treatment works and how the transferred cells behave or move in the body after being given.[1]
Study design and phase
This is a Phase 2 trial.[1] Phase 2 studies usually look for early signs that a treatment may help while continuing to collect research data in a larger group than very early trials.
The intervention listed in the source is AUTOLOGOUS REGULATORY T-CELLS WITH AN IMMUNOPHENOTYPE OF CD4+CD25HI/+FOXP3+, given by intravenous use.[1] The source also gives a dose expression of 5000000 IU/kg, but it does not provide more detail about how the treatment is prepared or how often it is given.[1]
Key patient terms
Clinical remission means the disease is much quieter, with very low or no important symptoms.[1] In this study, remission is checked by symptom scores and by looking inside the bowel with endoscopy.[1]
Endoscopy is a test that lets the research team look directly at the bowel lining.[1] Rectal bleeding and stool frequency are simple symptom measures used to track how active ulcerative colitis is.[1]
In-vivo homing means where the transferred cells go and how they behave inside the body after treatment.[1] This is important because the study is not only asking whether the treatment may help symptoms, but also what happens to the cells after they are given.[1]
