Table of contents
- Trial overview
- Who the trial is for
- Phase and study design
- What the trial measures
- How the treatment is given
- Trial summary
Trial overview
The available trial is titled MY-KIDNEY and studies ALLOGENEIC ADIPOSE-DERIVED MESENCHYMAL STEM CELLS IN VITRO EXPANDED in kidney transplant recipients with chronic active antibody mediated rejection.[1] The study is interventional, which means researchers give the treatment and watch what happens.[1]
The main objective is to assess safety, feasibility, immunomodulatory effects, and kidney-protective effects of intravenous allogeneic mesenchymal stromal cell therapy in this transplant setting.[1]
Who the trial is for
The target population is kidney transplant recipients who have chronic active antibody mediated rejection, often written as c-aABMR.[1] This is a problem where the body’s immune system attacks the transplanted kidney over time.[1]
The trial data do not list detailed inclusion or exclusion rules, so the source only confirms the broad patient group studied.[1]
Phase and study design
This is a Phase 1/2 trial.[1] Early phase studies usually focus on safety first, while also looking for early signs that the treatment may help.[1]
The study is authorised and plans to enroll 10 participants.[1] That small number fits an early research study that is still testing whether the approach is practical and safe.[1]
What the trial measures
The primary outcomes are feasibility, safety, and clinical outcomes.[1] Feasibility means whether participants can actually receive the MSC infusion as planned.[1]
Safety is measured by the number of participants without infusional toxicity, which means no harmful reaction during or right after the infusion.[1] Clinical outcome is measured by the number of participants without graft loss, death, or nephrectomy.[1]
How the treatment is given
The intervention is listed as MSC, adipose tissue (INTRAVENOUS USE).[1] Intravenous use means the treatment is given through a vein, usually as an infusion.[1]
The source data do not provide more details about dose, schedule, or repeat treatment, so the article only describes what is stated in the trial record.[1]
Trial summary
In simple terms, this study is an early test of ALLOGENEIC ADIPOSE-DERIVED MESENCHYMAL STEM CELLS IN VITRO EXPANDED for a serious kidney transplant complication.[1] It is designed to see whether the treatment can be given safely and whether it may help protect the transplanted kidney.[1]
Because the trial is small and in an early phase, it is mainly about learning whether the approach is workable and safe in this patient group.[1]
