Table of Contents
- Trial overview
- Who can participate
- What is being studied
- Trial phase and design
- Outcomes being measured
- What this means for patients
Trial overview
The available trial is titled SCARR, which studies ALLOGENEIC UMBILICAL CORD TISSUE-DERIVED MESENCHYMAL STROMAL CELLS EX VIVO EXPANDED for the treatment of chronic renal graft rejection.[1] It is listed as authorised and is an interventional study, meaning the researchers are giving a treatment and measuring the results.[1]
This trial focuses on adult kidney transplant recipients with chronic humoral rejection, also called chronic antibody-mediated rejection or cABMR.[1] The study plans to include 22 participants.[1]
Who can participate
The trial is designed for adult kidney transplant recipients who have developed chronic humoral rejection.[1] Their rejection must be confirmed by a kidney biopsy using the Banff 2017 Classification.[1]
People in the study also need to have disease that is resistant to conventional treatment.[1] In this trial, that means the rejection remained despite three injections of IVIG given at one-month intervals.[1]
What is being studied
The main treatment being studied is ALLOGENEIC UMBILICAL CORD TISSUE-DERIVED MESENCHYMAL STROMAL CELLS EX VIVO EXPANDED, given as an intravenous infusion.[1] The trial record also lists a 0.9% sodium chloride solution as another intervention.[1]
The study is not asking only whether the treatment can be given, but whether it may help improve kidney function in people with chronic rejection after transplant.[1] The trial summary says the goal is to evaluate the effectiveness of allogeneic UC-MSC injections on renal function at 24 months.[1]
Trial phase and design
This is a Phase 4 trial.[1] Phase 4 studies usually take place after earlier testing and are used to learn more about how a treatment performs in patients in a more real-world setting.
The study is interventional, which means the researchers actively give the study treatment rather than only observing patients.[1] The planned enrollment is 22 patients, so this is a small study focused on a specific group.[1]
Outcomes being measured
The primary outcome is the change in renal function between day 0 and month 24.[1] Renal function is measured using estimated glomerular filtration rate, or eGFR.[1]
eGFR is an estimate of how well the kidneys filter blood.[1] In simple terms, it helps show whether the transplanted kidney is working better, worse, or staying stable over time.
What this means for patients
For patients, this trial is looking at a difficult problem: long-term rejection after kidney transplant that has not improved with standard treatment.[1] The study is trying to see if ALLOGENEIC UMBILICAL CORD TISSUE-DERIVED MESENCHYMAL STROMAL CELLS EX VIVO EXPANDED may help protect kidney function over 2 years.[1]
Because the trial includes only adults with biopsy-proven chronic rejection and prior treatment failure, it is aimed at a very specific patient group.[1] The main result is not a symptom score, but a kidney function measure, which shows whether the treatment may help the transplanted kidney work better over time.[1]
