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Study on M2RLAB Cell Therapy for Treating Acute Kidney Injury in Patients After Heart Surgery

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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 treatment of acute kidney injury that occurs after cardiac surgery. The treatment being tested involves the use of modified autologous leukocyte cells, which are a type of cell therapy. These cells are specially prepared from the patient's own blood cells to help improve kidney function. The study will compare the effects of this cell therapy to a placebo, which is a substance with no active treatment.

The main goal of the study is to see how well the cell therapy works in helping the kidneys recover after surgery. Participants in the study will receive either the cell therapy or a placebo through an injection. The study will monitor how quickly kidney function returns to normal and will also look at the safety and any side effects of the treatment. The study will take place over a period of time, with regular check-ups to assess the participants' health and kidney function.

By participating in this study, researchers hope to find a new way to treat acute kidney injury after heart surgery, potentially improving recovery and reducing complications. The study will also gather information on the overall health and recovery of participants, including their time spent in the hospital and any additional treatments they may need. This research could lead to better treatment options for patients experiencing kidney problems after heart surgery.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, such as age, type of surgery, and risk of acute kidney injury (AKI).

    Informed consent is required, ensuring understanding of the study's purpose and procedures.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline health status, including kidney function tests and other relevant medical evaluations.

  3. Step 3

    Treatment administration

    The treatment involves the administration of modified autologous leukocyte cells or a placebo.

    The cells are administered through intravenous injection.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring of kidney function and overall health is conducted to assess the treatment's efficacy and safety.

    Monitoring includes measuring serum creatinine levels and other biomarkers.

  5. Step 5

    Evaluation of outcomes

    The primary outcome is the recovery time of renal function.

    Secondary outcomes include the incidence of major adverse kidney events, duration of hospital stay, and overall survival rates at 30 and 90 days.

  6. Step 6

    Completion of participation

    Participation concludes with a final assessment to evaluate long-term effects and any adverse events experienced during the study.

Who can join the trial?

5 criteria

  • Patients must be over 18 years old and able to understand and sign a consent form.
  • Patients should be undergoing planned heart surgery involving heart valves or coronary arteries, using a machine that temporarily takes over the function of the heart and lungs during surgery.
  • Patients must have a pre-surgery risk of developing acute kidney injury (AKI) of 30% or more, based on a specific risk scale called the Leicester Cardiosurgery Scale.
  • Patients must have AKI, which means their blood creatinine level has increased by more than 50% from their normal level, and a specific urine test result (NGAL value) greater than 200 micrograms per gram of creatinine, within the first 48 hours after heart surgery.
  • For women or men who can have children, they must agree to use birth control methods from the time they leave the hospital until they finish participating in the clinical trial, for safety reasons.

Who cannot join the trial?

3 criteria

  • Patients who have not developed acute kidney injury within 48 hours after cardiac surgery. Acute kidney injury means a sudden decrease in how well the kidneys are working.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means groups of people who might need special protection or care.
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Investigated drugs

Modified Autologous Leukocyte Cells are being studied for their potential to treat acute kidney injury (AKI) that occurs after cardiac surgery. These are special cells taken from the patient's own blood, which are then modified in a laboratory to enhance their ability to help the kidneys recover. The goal is to see if these cells can speed up the recovery of kidney function and to ensure that this treatment is safe and well-tolerated by patients.

What is already known about the treatment

Modified Autologous Leukocyte Cells – This treatment is administered through an infusion, where the patient's own modified white blood cells are reintroduced into their body. Currently, it is being studied in clinical trials and is not yet widely available in medical practice. The primary use of this therapy is to treat acute kidney injury that occurs after cardiac surgery. It works by enhancing the body's natural immune response to promote healing and recovery of kidney function. This therapy falls under the category of cell-based treatments, which are a part of regenerative medicine.

Investigated diseases

Acute Kidney Injury after Cardiac Surgery – This condition occurs when the kidneys suddenly become unable to filter waste products from the blood after cardiac surgery. It typically develops within 48 hours post-surgery and can lead to the accumulation of waste products and an imbalance of fluids and electrolytes in the body. The progression of acute kidney injury can vary, with some patients experiencing a rapid recovery of kidney function, while others may have prolonged impairment. Factors such as reduced blood flow to the kidneys during surgery, use of certain medications, or pre-existing kidney issues can contribute to its development. Monitoring of kidney function is crucial, as changes in creatinine levels and urine output are key indicators of the condition. The severity of the injury can range from mild, with minimal symptoms, to severe, requiring interventions like dialysis.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504610-30-01Protocol codeM2R.AKI.2021Estimated enrolment98 patientsSponsorM2rlab S.L.

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