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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for patients undergoing kidney transplantation from living donors. The treatment being tested involves the use of donor modified immune cells, known as MIC, which are special cells prepared in a laboratory to help manage the body's immune response after a transplant. These cells are given to patients through an injection into a vein.

The purpose of the study is to compare the effectiveness of this new treatment with the standard care currently used for kidney transplant patients. Participants in the study will be divided into three groups, with some receiving the MIC treatment and others receiving the standard care. The study will monitor how well the new treatment helps the body accept the new kidney without causing rejection or other complications.

Throughout the study, participants will be closely observed for any side effects or reactions to the treatment. The study will also track the overall health of the kidney transplant, including any signs of rejection or infection, and the general well-being of the participants. The goal is to determine if the MIC treatment can provide a better outcome for kidney transplant patients compared to the current standard treatments.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the trial's purpose and procedures. Written informed consent is required before any trial-related activities begin.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm eligibility. This includes a negative CDC crossmatch with the donor, a negative PCR test for SARS-CoV-2, and a negative pregnancy test for female patients of childbearing potential.
Step 3
Preparation for transplantation
The patient will prepare for kidney transplantation from a living donor. This involves ensuring compatibility with the donor's blood group and confirming the absence of specific antibodies that could affect the transplant.
Step 4
Treatment with MIC
The patient will receive treatment with MIC (donor modified immune cells) through intravenous injection. The aim is to achieve a state of operational tolerance, reducing the need for standard immunosuppressive therapy.
Step 5
Monitoring and follow-up
The patient will be monitored regularly to assess the effectiveness of the MIC treatment. This includes checking for any signs of rejection, infections, or other complications. The primary endpoint is evaluated on Visit Day 367, focusing on the absence of acute rejection, graft loss, or dysfunction.
Step 6
Completion of the trial
The trial concludes with a final assessment on Visit Day 367. The patient's health, quality of life, and any changes in treatment will be evaluated to determine the overall success of the MIC therapy compared to standard care.

Who can join the trial?

15 criteria

Donors: Must be at least 18 years old and able to give consent.
Patients: Must have chronic kidney disease (CKD) in stage 5, which means very low kidney function or on dialysis, and be preparing for a kidney transplant from a living donor.
Must be between 18 and 74 years old.
Must have a blood type that is the same or compatible with the donor's blood type.
This must be the patient's first kidney transplant.
Must have low levels of certain antibodies (less than 20%) that could react with the donor's cells.
Must not have specific antibodies against the donor's tissue, as tested by a special lab test called the Luminex-Assay.
Must have a negative result on a test called CDC crossmatch, which checks for reactions between the patient's and donor's cells.
Must have a negative PCR test for COVID-19 at the time of screening.
The patient's living donor must have given written consent to participate in the trial.
Must be able to understand the nature and scope of the clinical trial.
Must provide written informed consent before any trial-related procedures.
Female patients: If they can have children, they must have a negative pregnancy test and agree to use two highly effective methods of birth control or practice true abstinence during the trial. They must also agree not to breastfeed during the trial.
Male patients: Must agree to practice true abstinence or use a condom during sexual contact with a pregnant woman or a woman who can have children during the trial and for at least 90 days after the trial, even if they have had a vasectomy.
Donors: Must be able to understand the nature and scope of the clinical trial and provide written consent before any trial-related procedures, including donating blood cells.

Who cannot join the trial?

5 criteria

Patients who are not undergoing a living donor kidney transplantation cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial groups cannot participate.
Patients who are not male or female cannot participate.
Patients who are not considered part of a vulnerable population cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Charite Universitaetsmedizin Berlin KöR
Verified
Berlin, Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Verified
Munich, Germany
Ludwig Maximilian University Of Munich
Responsive
Munich, Germany

Trial locations

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Investigated drugs

MIC is a treatment that involves using special immune cells that have been modified to help the body accept a new kidney from a living donor. These cells are given through an IV, which means they are delivered directly into the bloodstream. The goal of this treatment is to help the body tolerate the new kidney better, reducing the need for other medications that suppress the immune system.

ALLOGENEIC PERIPHERAL BLOOD MONONUCLEAR CELLS INCUBATED IN VITRO WITH MITOMYCIN C

What is already known about the treatment

MIC (Modified Immune Cells) – This medication is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials for its use in living donor kidney transplantation. The main purpose of MIC is to help the body accept a new kidney by modifying the immune system to prevent rejection. At the molecular level, it works by altering immune cells to achieve a state similar to operational tolerance, where the body does not attack the transplanted organ. MIC falls under the category of immunosuppressive therapies, which are used to reduce the activity of the immune system.

Investigated diseases

Living donor kidney transplantation – Living donor kidney transplantation involves transferring a healthy kidney from a living donor to a recipient with kidney failure. The process begins with the surgical removal of the donor's kidney, which is then implanted into the recipient. After transplantation, the recipient's body may initially recognize the new kidney as foreign, potentially leading to immune responses. Over time, the recipient's immune system may adapt, allowing the transplanted kidney to function properly. The success of the transplantation depends on the recipient's ability to achieve immune tolerance, minimizing the risk of rejection. Regular monitoring and management are essential to ensure the long-term health of the transplanted kidney.