In short
Clinical trials of ALLOGENEIC ADIPOSE-DERIVED MESENCHYMAL STEM CELLS IN VITRO EXPANDED are studying whether this treatment can help kidney transplant recipients with chronic active antibody mediated rejection. The trials mainly look at safety, feasibility, and possible kidney-protective effects. They focus on patients with this transplant complication.
Key points
- ALLOGENEIC ADIPOSE-DERIVED MESENCHYMAL STEM CELLS IN VITRO EXPANDED is being studied in a Phase 1/2 trial in kidney transplant recipients with chronic active antibody mediated rejection. The main goals are to check feasibility, safety, and possible kidney-protective effects. The trial uses intravenous treatment and plans to enroll 10 participants. Key outcomes include whether participants can receive the infusion, whether there is infusion-related toxicity, and whether graft loss, death, or nephrectomy occurs. The study is authorised and focuses on early clinical testing in a transplant population.
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. The study is interventional, which means researchers give the treatment and watch what happens.
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.
Who the trial is for
The target population is kidney transplant recipients who have chronic active antibody mediated rejection, often written as c-aABMR. This is a problem where the body’s immune system attacks the transplanted kidney over time.
The trial data do not list detailed inclusion or exclusion rules, so the source only confirms the broad patient group studied.
Phase and study design
This is a Phase 1/2 trial. Early phase studies usually focus on safety first, while also looking for early signs that the treatment may help.
The study is authorised and plans to enroll 10 participants. That small number fits an early research study that is still testing whether the approach is practical and safe.
What the trial measures
The primary outcomes are feasibility, safety, and clinical outcomes. Feasibility means whether participants can actually receive the MSC infusion as planned.
Safety is measured by the number of participants without infusional toxicity, which means no harmful reaction during or right after the infusion. Clinical outcome is measured by the number of participants without graft loss, death, or nephrectomy.
How the treatment is given
The intervention is listed as MSC, adipose tissue (INTRAVENOUS USE). Intravenous use means the treatment is given through a vein, usually as an infusion.
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.
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. It is designed to see whether the treatment can be given safely and whether it may help protect the transplanted kidney.
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.