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ALLOGENEIC PERIPHERAL BLOOD MONONUCLEAR CELLS INCUBATED IN VITRO WITH MITOMYCIN C

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.

Table of contents

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.[1] The study is a Phase 2 trial with 126 planned participants.[1]

The trial compares MIC treatment with standard-of-care therapy to see whether the study treatment can improve transplant outcomes.[1]

Who is being studied

This trial is for people receiving a kidney transplant from a living donor.[1] 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.[1]

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.[1]

Trial design and phase

This is an interventional study, which means researchers assign a treatment and then measure the results.[1] It is also described as a non-blinded Phase 2 study with 3 randomized patient groups.[1]

Phase 2 trials usually focus on whether a treatment works and continue to follow safety closely.[1] In this study, the main comparison is MIC treatment versus standard-of-care therapy.[1]

What is being measured

The primary outcome is the proportion of patients who achieve an operational tolerance-like phenotype by Visit Day 367.[1] This is a combined measure, so patients must meet all listed conditions to count as a success.[1]

The required conditions are no acute rejection, no graft loss, no graft dysfunction, and no death by Visit Day 367.[1] The study also checks that no donor-specific HLA antibodies develop up to that time.[1]

Another part of the outcome is Breg induction of at least 3% on Visit Day 367.[1] Breg means regulatory B cells, a type of immune cell measured in the blood.[1]

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.[1]

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.[1] For patients, the key question is whether the transplant can stay healthy with fewer signs of immune attack.[1]

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.[1]

Trial IDPhaseCondition studiedStatusEnrollment
NCT05365672Phase 2Living donor kidney transplantationAuthorised126

FAQ

  • What is being studied in these trials? The trials study ALLOGENEIC PERIPHERAL BLOOD MONONUCLEAR CELLS INCUBATED IN VITRO WITH MITOMYCIN C as part of a strategy called MIC treatment. The goal is to compare it with standard-of-care treatment in kidney transplant patients.
  • Who can take part in the trial? The trial is for people receiving a kidney transplant from a living donor. It is designed for transplant patients who are being treated after surgery.
  • What phase is the trial? This is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment works and continue to monitor safety.
  • What condition is being studied? The condition is living donor kidney transplantation. The trial compares MIC treatment with standard-of-care care in this setting.
  • What outcome is the trial measuring? The main outcome is the proportion of patients who reach an operational tolerance-like phenotype by Visit Day 367. This means no acute rejection, no graft loss, no graft dysfunction or death, no donor-specific HLA antibodies, a Breg level of at least 3%, and continued tacrolimus-based treatment without corticosteroids.

Ongoing Clinical Trials on ALLOGENEIC PERIPHERAL BLOOD MONONUCLEAR CELLS INCUBATED IN VITRO WITH MITOMYCIN C

  • Study on Immune System Suppression Using Donor Modified Immune Cells (MIC) for Patients Undergoing Living Donor Kidney Transplantation

    Recruiting

    1 1
    Investigated drugs:
    Germany

Glossary

  • Living donor kidney transplantation: A kidney transplant where the donated kidney comes from a living person.
  • Phase 2: A study stage that looks more closely at whether a treatment works and continues to monitor safety.
  • Interventional study: A trial where researchers assign a treatment and then measure its effects.
  • Standard-of-care: The usual treatment that is commonly given in medical practice.
  • Operational tolerance-like phenotype: A set of results showing the transplant is doing well without signs of rejection and with stable treatment needs.
  • Acute rejection: A sudden immune reaction where the body attacks the transplanted organ.
  • Graft loss: When the transplanted organ no longer works and is lost.
  • Graft dysfunction: When the transplanted organ is not working as well as expected.
  • Donor-specific HLA antibodies: Antibodies made by the patient that target the donor organ and may harm the transplant.
  • Breg: Regulatory B cells, a type of immune cell measured in this trial.
  • Tacrolimus: A medicine used after transplant to help prevent rejection.
  • Corticosteroids: A type of anti-inflammatory medicine often used to reduce immune activity.

References