Modified Autologous Leukocyte Cells for the Treatment of Acute Kidney Injury After Cardiac Surgery

May 7, 2026 updated by: M2RLAB SL

The purpose of this clinical trial is to assess the efficacy and safety of cell therapy with modified leukocyte cells from the participant himself/herself versus placebo in participants who develop Acute Kidney Injury (AKI) within the first 48 hours after cardiac surgery.

The main questions it aims to answer are:

  • Does cell therapy reduce the recovery time of kidney function?
  • What medical problems do participants have when receiving cell therapy?

Researchers will compare cell therapy with a placebo (a look-alike substance that contains no drug) to see if cell therapy works to treat AKI. The safety of cell therapy with leukocyte cells will also be studied.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase II, multi-center, randomized, placebo-controlled clinical trial, with 2 treatment arms and single blind. After being informed about the study, participants who meet the eligibility criteria will be randomized in 1:1 ratio to treatment with a single administration of cell therapy with leukocyte cells from the participant himself/herself or placebo (approximately 49 subjects per group).

Acute kidney injury (AKI) is one of the main complications after cardiac surgery. In fact, AKI after cardiac surgery is associated with high morbidity and mortality. Currently, there are no effective therapies for kidney injury after cardiac surgery, but there is evidence that recovery is possible if the injury processes are overcome. Thus, due to the lack of preventive and therapeutic options at present, cell therapy has gained importance in recent years in different clinical trials. Thus, within this context, the use of modified leukocyte cells as cell therapy is also an alternative for the treatment of AKI due to their powerful immunomodulatory effect. On the other hand, the use of placebo is justified because there is currently no other pharmacological treatment available to serve as an active control. A placebo-controlled study is optimal to evaluate the efficacy and safety of an experimental treatment.

Researchers hypothesized that cell therapy with autologous leukocyte cells can be safe, well tolerated and clinically beneficial versus placebo for participants who develop AKI within the first 48 hours after cardiac surgery.

This study consists of 3 phases: the initial phase, the observation phase, and the follow-up phase. The total duration of each participant in the trial will be from 3 to 5 months:

  • Initial phase: It starts when the participant signs the informed consent (IC) and it lasts until he or she receives the investigational drug/placebo. There are two possible scenarios: The participants undergoing cardiac surgery can sign the informed consent (IC) before the surgery (at a scheduled visit prior to his/her hospitalization or at the time of his/her hospitalization and prior to undergoing the procedure) or, alternatively, they can sign the informed consent (IC) after the surgery and the development of AKI within 48 hours. As indicated in the Inclusion criteria, only participants who present AKI within the first 48 hours post cardiac surgery will be included. The participants who meet all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to one of the two study groups. A volume of at least 60 mL of peripheral blood will be extracted from the participant, from which the cell therapy will be prepared (in cases where the participant is included in the experimental group) The investigational product/placebo will be administered to the participant within 48 hours of AKI diagnosis.
  • Observation phase: It includes the period from when the participant receives the investigational drug/placebo until he or she is discharged from the hospital. This period lasts 16 to 20 days, depending on the clinical evolution of the participants. During this phase, participants will be followed and will undergo different tests to evaluate the effectiveness and safety of the investigational treatment vs. placebo.
  • Follow-up phase: It includes the period from when the participant receives hospital discharge and ends 90 days from the date of inclusion of the participant in the study. At this stage, participants will be monitored to evaluate the efficacy and safety of the experimental cell therapy drug vs. placebo.

Besides, if the participants give their consent, blood and urine samples will be collected to perform a metabolomic sub-study. The main objective is to identify biomarkers of efficacy of the treatment with M2RLAB 001.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08036
        • Recruiting
        • Hospital Clinic of Barcelona
        • Contact:
          • Esteban Poch López de Briñas
        • Principal Investigator:
          • Esteban Poch López de Briñas, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female participants older than 18 years of age, being able to understand and sign the Informed Consent.
  2. Participants undergoing elective valvular and/or coronary cardiac surgery performed with extracorporeal circulation.

  3. Participants must meet one of the following two criteria:

    1. Present pre-operative AKI risk more or equal to 30 percent according to the Leicester Cardiosurgery scale, in case the participants had signed the IC before.
    2. Participants that had signed the IC within 12 hours after the AKI diagnosis.

  4. Present AKI within the first 48 hours post cardiac surgery in one of the following classifications defined by the AKIN scale (Acute Kidney Injury Network):

    AKIN 1: An increase in serum creatinine by at least 0.3 mg/dL (more or equal to 26.4 micromol/L) from baseline, or an increase to more or equal to 150-200 percent (corresponding to a 1.5- to 2-fold increase) from baseline. In addition, the participant must have a positive acute tubular necrosis score within the first 48 hours post cardiac surgery, defined as the presence of at least 3 of the following 4 scenarios: Sodium excretion fraction more than 2 percent, urinary osmolality lower than 400 mOsm/kg, urine sodium more than 40 mmol/L, presence of shock or nephrotoxic agents.

    AKIN 2: An increase in serum creatinine to more than 200 percent and up to a maximum of 300 percent (corresponding to an increase of more than 2 and up to 3 times) over baseline.

    AKIN 3: An increase in serum creatinine to more than 300 percent (corresponding to more than 3-fold increase) over baseline, or an increase in serum creatinine levels to more or equal to 4.0 mg/dl (more or equal to 354 micromol/l) with an acute increase of at least 0.5 mg/dl (44 micromol/l).

  5. In the case of women or men of childbearing age, for safety, those who undertake to follow the contraceptive measures required from their discharge from hospital until the end of their participation in the clinical trial.

Exclusion Criteria:

  1. Chronic Kidney Disease (CKD) in stage IV or V (glomerular filtration rate [GFR] less than 30 ml/min).
  2. AKI one month prior to heart surgery.
  3. Participants who have previously undergone renal replacement therapy.
  4. Participants who, due to their clinical situation (hemodynamic instability, oliguria, current or anticipated volume overload) are scheduled to start renal replacement therapy within the next 48 hours after AKI diagnosis.
  5. Interstitial glomerulonephritis or vasculitis.
  6. Pregnancy.
  7. Women in breastfeeding period
  8. Renal transplant history.
  9. Endocarditis.
  10. Participants with mechanical assistance devices: extracorporeal membrane oxygenation (ECMO), left ventricular assist device (LVAD), right ventricular assist device (RVAD), intra-aortic balloon pumps (IABP).
  11. Known severe ventricular dysfunction (left ventricular ejection fraction [LVEF] less than 30 percent).
  12. Post-surgical septic infectious condition.
  13. Clinically significant anemia with hemoglobin values below 100g/l.
  14. Positive serology for hepatitis C virus (HCV), hepatitis B virus antigen (HBSAg), human immunodeficiency virus (HIV) or syphilis (by RPR: Rapid Plasma Reagin). This criterion will be assessed once it has been confirmed that the participant has developed AKI.
  15. Participants enrolled in another clinical trial testing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Saline Solution for injection
Participants randomized to placebo will receive a single 10 mL dose Intravenous (IV) infusion of normal saline (0.9 percent) no later than 48 hours after the participant's diagnosis of AKI.
Drug: Placebo
Intravenous infusion of normal saline.
Other Names:
  • Saline Solution
Experimental: Cell therapy with leukocyte cells from the participant himself/herself
Participants randomized to experimental group will receive a single 10 mL dose IV of leukocyte cells concentration of 6-15.4 x10^6 cells/mL no later than 48 hours after the participant's diagnosis of AKI.
Drug: M2RLAB 001
Intravenous infusion of M2RLAB 001
Other Names:
  • Autologous Leukocyte Cells

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recovery time of kidney function
Time Frame: Baseline Phase (Day 0), Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment)
Time (in days) to recovery of the creatinine to baseline values (in the range of more or less than 30 percent from baseline).
Baseline Phase (Day 0), Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment)
Proportion of participants with persistently altered creatinine values (more than 31 percent from baseline values) 7 days after AKI episode
Time Frame: Baseline Phase (Day 0), Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment
Measured as the incidence of Acute Kidney Disease (AKD): persistence of altered creatinine values 7 days after the AKI episode.
Baseline Phase (Day 0), Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment
Occurrence of adverse events (AEs)
Time Frame: Up to Day 90
Number of AEs reported.
Up to Day 90
Occurrence of serious AEs (SAEs)
Time Frame: Up to Day 90
Number of SAEs reported
Up to Day 90
Occurrence of AEs resulting in discontinuation of study treatment
Time Frame: Up to Day 90
Number of AEs resulting in discontinuation of study treatment reported
Up to Day 90
Occurrence of AEs of special interest (AESIs)
Time Frame: Up to Day 90
Number of AESIs reported.
Up to Day 90

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to appear of Major Adverse Kidney Events (MAKE)
Time Frame: Up to Day 90
Time to appear of MAKE. MAKE is considered as the development of events related to disease progression, which is defined as death related to renal failure, need for dialysis or permanent reduction of estimated Glomerular Filtration Rate more than 30 percent since baseline
Up to Day 90
Number of participants on renal replacement therapy
Time Frame: Up to Day 90
Number of participants requiring dialysis
Up to Day 90
Renal replacement therapy duration.
Time Frame: Up to Day 90
Time (in days) of the required dialysis.
Up to Day 90
Duration of admission to Intensive Care Unit (ICU)
Time Frame: Up to Day 90
Time (in days) of ICU stay of participants.
Up to Day 90
Duration of hospital stay
Time Frame: Up to Day 90
Time (in days) of hospital stay of participants.
Up to Day 90
Patient survival after 30 days
Time Frame: Up to Day 30
Proportion of participants who survived after 30 days.
Up to Day 30
Patient survival after 90 days
Time Frame: Up to Day 90
Proportion of participants who survived after 90 days.
Up to Day 90
Participants requiring dialysis versus participants who survived without requiring dialysis after 30 days
Time Frame: Up to Day 30
Proportion of participants who survived requiring dialysis versus participants who survived without requiring dialysis after 30 days post cardiac surgery.
Up to Day 30
Participants requiring dialysis versus participants who survived without requiring dialysis after 90 days
Time Frame: Up to Day 90
Proportion of participants who survived requiring dialysis versus participants who survived without requiring dialysis after 90 days post cardiac surgery.
Up to Day 90
Maximum creatinine values (peak creatinine) recorded during participants' hospitalization
Time Frame: Baseline Phase: Day 0 and Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment)
Maximum creatinine value (peak creatinine) recorded. Creatinine levels will be measured in serum.
Baseline Phase: Day 0 and Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment)
Time (day) of maximum creatinine values (peak creatinine) recorded during participants' hospitalization
Time Frame: Baseline Phase: Day 0 and Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment)
Day of maximum creatinine values (peak creatinine) recorded. Creatinine levels will be measured in serum.
Baseline Phase: Day 0 and Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment)
Improvement in levels of injury biomarkers in urine
Time Frame: Baseline Phase: Day 0 and Observation Phase: Visit 7 (7 days after treatment)
Proportion of participants with variations of more than 30 percent in the values of injury biomarkers in urine [Albumin and Neutrophil gelatinase-associated lipocalin (NGAL)]
Baseline Phase: Day 0 and Observation Phase: Visit 7 (7 days after treatment)
Participants presenting surgical wound infections
Time Frame: Up to Day 90
Proportion of participants with surgical wound infections.
Up to Day 90
Participants presenting respiratory infections during ICU stay
Time Frame: Up to Day 90
Proportion of participants with respiratory infections during ICU stay.
Up to Day 90
Participants who present complications related to surgery
Time Frame: Up to Day 90
Proportion of participants with any complication related to surgery (Sternotomy, Reintervention, Circulatory support).
Up to Day 90
Number of complications related to surgery
Time Frame: Up to Day 90
Absolute number of any complication related to surgery (Sternotomy, Reintervention, Circulatory support).
Up to Day 90
Unexplained haemodynamic worsening
Time Frame: Observational Phase: Day 1 and Day 7
Unexplained haemodynamic worsening measured as: drop in cardiac index to less than 2.5 L/min/m^2 (if it was previously higher), drop in systemic systolic blood pressure more than 30 percent or to less than 90 mmgHg, and/or more than 30 increase in vasoactive drugs dose.
Observational Phase: Day 1 and Day 7
Major Adverse Kidney Events (MAKE) incidence reduction
Time Frame: Baseline Phase: Day 0, Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment) and Follow-up phase: Day 30 and 90
Proportion of participants with MAKE incidence reduction. MAKE is considered as the development of events related to disease progression, which is defined as death related to renal failure, need for dialysis or permanent reduction of estimated Glomerular Filtration Rate more than 30 percent since baseline
Baseline Phase: Day 0, Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment) and Follow-up phase: Day 30 and 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M2RLAB SL

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Esteban Poch López de Briñas, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 14, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 17, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 2, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M2R.AKI.2021
  • 2023-504610-30-01 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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