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M2Rlab

A groundbreaking clinical trial is underway to evaluate the effectiveness of M2Rlab, a modified autologous leukocyte cell therapy, in treating acute kidney injury (AKI) following cardiac surgery. This phase II study aims to assess the safety, efficacy, and optimal dosage of M2Rlab compared to a placebo in patients who develop AKI within 48 hours after heart surgery. The trial focuses on improving renal function recovery time and reducing complications associated with AKI in this vulnerable patient population.

Table of Contents

What is M2RLAB?

M2RLAB is an innovative cell therapy being studied for the treatment of acute kidney injury (AKI) in patients who have undergone cardiac surgery[1]. This therapy uses modified autologous leukocyte cells, which means it’s made from a patient’s own white blood cells that have been specially processed[1]. M2RLAB is classified as a biological and advanced therapy medicinal product, indicating its cutting-edge nature in medical treatment[1].

Medical Condition: Acute Kidney Injury (AKI) After Cardiac Surgery

Acute kidney injury is a sudden decrease in kidney function that can occur after major surgeries, especially heart surgeries[1]. This condition can be serious and may lead to complications, extended hospital stays, and in some cases, the need for dialysis. M2RLAB is being developed specifically to address AKI that develops within 48 hours after cardiac surgery[1].

How M2RLAB Works

M2RLAB is administered intravenously (through a vein) as an injectable solution[1]. The therapy uses a patient’s own white blood cells (leukocytes) that have been modified to potentially help repair and protect the kidneys after injury. While the exact mechanism is still being studied, it’s believed that these modified cells may help reduce inflammation and promote healing in the damaged kidney tissue[1].

Clinical Trial Details

M2RLAB is currently being evaluated in a Phase II clinical trial[1]. This stage of research aims to assess both the safety and effectiveness of the treatment, as well as determine the best dosing regimen. The study is comparing M2RLAB to a placebo in patients who develop AKI within 48 hours after cardiac surgery[1].

The main goals of the trial include:

  • Measuring how quickly kidney function recovers in patients treated with M2RLAB compared to placebo[1]
  • Assessing the safety and tolerability of the treatment[1]
  • Evaluating the need for and duration of dialysis in treated patients[1]
  • Comparing the length of hospital and intensive care unit (ICU) stays between treated and untreated patients[1]
  • Analyzing survival rates and kidney function at 30 and 90 days after treatment[1]

Eligibility Criteria

Not all patients with AKI after cardiac surgery will be eligible for this trial. Some key inclusion criteria are:

  • Adults over 18 years of age[1]
  • Undergoing elective heart valve and/or coronary surgery with extracorporeal circulation (a machine that temporarily takes over the function of the heart and lungs during surgery)[1]
  • Having a high risk (≥30%) of developing AKI after surgery, based on a specific assessment scale[1]
  • Developing AKI within 48 hours after surgery, confirmed by blood and urine tests[1]

Patients with certain conditions may not be eligible, including those with severe kidney disease before surgery, very poor heart function, or those who have had a kidney transplant[1].

Potential Benefits of M2RLAB

While the effectiveness of M2RLAB is still being studied, the researchers hope to see several potential benefits, including:

  • Faster recovery of kidney function after AKI[1]
  • Reduced need for dialysis[1]
  • Shorter stays in the ICU and hospital[1]
  • Improved survival rates at 30 and 90 days after treatment[1]
  • Lower risk of developing chronic kidney problems[1]

Safety and Side Effects

As with any new treatment, safety is a primary concern. The clinical trial is closely monitoring for any side effects or complications that may arise from M2RLAB treatment. Specific areas being watched include:

  • Infectious complications[1]
  • Surgery-related complications[1]
  • Changes in heart function[1]
  • Any unexpected adverse events[1]

It’s important to note that as M2RLAB is still in the research phase, all potential risks and benefits are not yet fully known. Patients considering participation in the clinical trial should discuss the potential risks and benefits thoroughly with their healthcare providers[1].

Aspect Details
Drug Name M2Rlab (Mononuclear cells M2RLAB)
Type of Therapy Modified autologous leukocyte cell therapy
Condition Treated Acute kidney injury after cardiac surgery
Trial Phase Phase II
Administration Intravenous injection, max 10 ml daily dose
Primary Objectives Assess renal function recovery time, reduce persistent kidney problems, evaluate safety
Key Eligibility Adults 18+, undergoing cardiac surgery, high AKI risk, develop AKI within 48h post-surgery
Main Outcomes Measured Kidney function recovery, need for dialysis, hospital stay duration, survival rates

FAQ

  • What is M2Rlab? M2Rlab is a type of cell therapy made from modified autologous leukocyte cells. These are white blood cells taken from the patient's own body and specially prepared for treatment. It's being studied as a potential treatment for acute kidney injury that occurs after heart surgery.
  • How is M2Rlab administered? M2Rlab is given as an injectable medication through intravenous use. The maximum daily dose in the trial is 10 milliliters, and the treatment period is up to one day.
  • Who is eligible for this clinical trial? The trial is open to adults over 18 years old who are undergoing elective heart valve and/or coronary surgery with extracorporeal circulation. They must have a high risk of AKI and develop it within 48 hours after surgery. There are specific criteria for kidney function and other health factors that determine eligibility.
  • What are the main goals of this clinical trial? The primary goals are to assess how quickly kidney function recovers with M2Rlab compared to a placebo, to determine if it reduces persistent kidney problems, and to evaluate its safety. The trial also looks at several secondary objectives, such as the need for dialysis, length of hospital stay, and survival rates.
  • What are the potential benefits of participating in this trial? Participants may benefit from potentially improved kidney function recovery, reduced need for dialysis, and shorter hospital stays. However, it's important to note that as this is a clinical trial, the effectiveness of M2Rlab is still being studied, and there may be risks involved.

Ongoing Clinical Trials on M2Rlab

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

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Acute Kidney Injury (AKI): A sudden decrease in kidney function that occurs within a few hours or days. In this trial, it's specifically related to complications after heart surgery.
  • Autologous: Derived from the same individual. In this case, the leukocyte cells used in M2Rlab come from the patient's own body.
  • Leukocyte: Another term for white blood cells, which are part of the body's immune system.
  • Extracorporeal Circulation: A technique used during heart surgery where blood is circulated outside the body with the help of a machine.
  • Renal Replacement Therapy: Treatment that takes over the job of the kidneys when they're not working properly, such as dialysis.
  • Creatinine: A waste product in the blood that's normally filtered out by healthy kidneys. High levels can indicate kidney problems.
  • Glomerular Filtration Rate (GFR): A measure of how well the kidneys are filtering waste from the blood.
  • MAKE (Major Adverse Kidney Events): A combined measure of serious kidney-related outcomes, including death, need for dialysis, or significant long-term reduction in kidney function.
  • Placebo: An inactive substance used in clinical trials to compare the effects of a new treatment against no treatment.
  • Phase II Trial: A stage of clinical research that tests a new treatment in a larger group of people to evaluate its effectiveness and safety.

References

  1. http://clinicaltrials.eu/trial/study-on-m2rlab-cell-therapy-for-treating-acute-kidney-injury-in-patients-after-heart-surgery/