In short
Clinical trials are studying ALLOGENEIC PERIPHERAL BLOOD MONONUCLEAR CELLS INCUBATED IN VITRO WITH MITOMYCIN C in living donor kidney transplantation. The main goal is to see whether it helps patients reach an operational tolerance-like state, with less rejection and stable graft function. These trials focus on safety and efficacy in transplant patients.
Key points
- Clinical trials are studying ALLOGENEIC PERIPHERAL BLOOD MONONUCLEAR CELLS INCUBATED IN VITRO WITH MITOMYCIN C in people receiving a kidney transplant from a living donor. The trial is Phase 2 and compares MIC treatment with standard-of-care care. The main goal is to see whether more patients reach an operational tolerance-like phenotype by Visit Day 367. The study looks at important transplant results such as rejection, graft loss, graft function, donor-specific HLA antibodies, Breg levels, and ongoing tacrolimus treatment without corticosteroids. One authorised interventional trial with 126 participants is listed in the source data.
Trial overview
The source data includes one authorised interventional study of ALLOGENEIC PERIPHERAL BLOOD MONONUCLEAR CELLS INCUBATED IN VITRO WITH MITOMYCIN C in living donor kidney transplantation. The study is a Phase 2 trial with 126 planned participants.
The trial compares MIC treatment with standard-of-care therapy to see whether the study treatment can improve transplant outcomes.
Who is being studied
This trial is for people receiving a kidney transplant from a living donor. In simple terms, the study population is transplant patients after surgery, when the main concern is whether the new kidney stays healthy and is accepted by the body.
The trial title says the study uses individualized suppression of the patient's immune system with donor modified immune cells, which means the researchers are testing a personalized transplant strategy.
Trial design and phase
This is an interventional study, which means researchers assign a treatment and then measure the results. It is also described as a non-blinded Phase 2 study with 3 randomized patient groups.
Phase 2 trials usually focus on whether a treatment works and continue to follow safety closely. In this study, the main comparison is MIC treatment versus standard-of-care therapy.
What is being measured
The primary outcome is the proportion of patients who achieve an operational tolerance-like phenotype by Visit Day 367. This is a combined measure, so patients must meet all listed conditions to count as a success.
The required conditions are no acute rejection, no graft loss, no graft dysfunction, and no death by Visit Day 367. The study also checks that no donor-specific HLA antibodies develop up to that time.
Another part of the outcome is Breg induction of at least 3% on Visit Day 367. Breg means regulatory B cells, a type of immune cell measured in the blood.
The final part of the primary outcome is that the patient remains on tacrolimus therapy with ≤720 mg ECMPS and no corticosteroids on Visit Day 277, and stays on that same treatment through Visit Day 367.
Why this trial matters
The study is trying to find out whether MIC treatment can help kidney transplant patients reach a more stable immune state than standard care alone. For patients, the key question is whether the transplant can stay healthy with fewer signs of immune attack.
Because the trial measures several transplant outcomes together, it gives a broad view of how well the treatment strategy may work in real transplant care.