In short
Clinical trials are studying ALLOGENEIC UMBILICAL CORD TISSUE-DERIVED MESENCHYMAL STROMAL CELLS EX VIVO EXPANDED in people with chronic kidney transplant rejection. The main goal is to see whether it can improve kidney function and how well it is tolerated in patients who did not respond to standard treatment.
Key points
- Clinical trials are studying ALLOGENEIC UMBILICAL CORD TISSUE-DERIVED MESENCHYMAL STROMAL CELLS EX VIVO EXPANDED in adult kidney transplant recipients with chronic humoral rejection. The trial is for patients whose rejection was confirmed by kidney biopsy and who did not respond to standard treatment with IVIG. It is a Phase 4 interventional study with 22 planned participants. The main goal is to see whether kidney function changes over 24 months. Researchers are using eGFR, a measure of how well the kidneys filter blood, as the main outcome.
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. It is listed as authorised and is an interventional study, meaning the researchers are giving a treatment and measuring the results.
This trial focuses on adult kidney transplant recipients with chronic humoral rejection, also called chronic antibody-mediated rejection or cABMR. The study plans to include 22 participants.
Who can participate
The trial is designed for adult kidney transplant recipients who have developed chronic humoral rejection. Their rejection must be confirmed by a kidney biopsy using the Banff 2017 Classification.
People in the study also need to have disease that is resistant to conventional treatment. In this trial, that means the rejection remained despite three injections of IVIG given at one-month intervals.
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. The trial record also lists a 0.9% sodium chloride solution as another intervention.
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. The trial summary says the goal is to evaluate the effectiveness of allogeneic UC-MSC injections on renal function at 24 months.
Trial phase and design
This is a Phase 4 trial. 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. The planned enrollment is 22 patients, so this is a small study focused on a specific group.
Outcomes being measured
The primary outcome is the change in renal function between day 0 and month 24. Renal function is measured using estimated glomerular filtration rate, or eGFR.
eGFR is an estimate of how well the kidneys filter blood. 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. 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.
Because the trial includes only adults with biopsy-proven chronic rejection and prior treatment failure, it is aimed at a very specific patient group. 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.