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

NCT07052513 | Recruiting Phase 2 DMC

• 2 other identifiers: M2R.AKI.20212023-504610-30-01
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Kidney Injury

Keywords

Cardiac Surgery; Thoracic Surgery; Acute Renal Insufficiency; Acute Renal Injury; Major Adverse Kidney Event; Autologous Leukocyte Cells; Leukocyte Cells; Autologous Mononuclear Cells; Mononuclear Cells; Acute Kidney Disease

Outcome Measures

Primary Outcomes (6)

• Recovery time of kidney function

  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

  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)

  Number of AEs reported.

  Up to Day 90

• Occurrence of serious AEs (SAEs)

  Number of SAEs reported

  Up to Day 90

• Occurrence of AEs resulting in discontinuation of study treatment

  Number of AEs resulting in discontinuation of study treatment reported

  Up to Day 90

• Occurrence of AEs of special interest (AESIs)

  Number of AESIs reported.

  Up to Day 90

Secondary Outcomes (18)

• Major Adverse Kidney Events (MAKE) incidence reduction

  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

• Time to appear of Major Adverse Kidney Events (MAKE)

  Up to Day 90

• Number of participants on renal replacement therapy

  Up to Day 90

• Renal replacement therapy duration.

  Up to Day 90

• Duration of admission to Intensive Care Unit (ICU)

  Up to Day 90

Study Arms (2)

Saline Solution for injection

PLACEBO COMPARATOR

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

Cell therapy with leukocyte cells from the participant himself/herself

EXPERIMENTAL

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

Interventions

Placebo DRUG

Intravenous infusion of normal saline.

Also known as: Saline Solution

Saline Solution for injection

M2RLAB 001 DRUG

Intravenous infusion of M2RLAB 001

Also known as: Autologous Leukocyte Cells

Cell therapy with leukocyte cells from the participant himself/herself

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants older than 18 years of age, being able to understand and sign the Informed Consent.
• Participants undergoing elective valvular and/or coronary cardiac surgery performed with extracorporeal circulation.
• Participants must meet one of the following two criteria:
• 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.
• Participants that had signed the IC within 12 hours after the AKI diagnosis.
• 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).
• 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.

You may not qualify if:

• Chronic Kidney Disease (CKD) in stage IV or V (glomerular filtration rate \[GFR\] less than 30 ml/min).
• AKI one month prior to heart surgery.
• Participants who have previously undergone renal replacement therapy.
• 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.
• Interstitial glomerulonephritis or vasculitis.
• Pregnancy.
• Women in breastfeeding period
• Renal transplant history.
• Endocarditis.
• Participants with mechanical assistance devices: extracorporeal membrane oxygenation (ECMO), left ventricular assist device (LVAD), right ventricular assist device (RVAD), intra-aortic balloon pumps (IABP).
• Known severe ventricular dysfunction (left ventricular ejection fraction \[LVEF\] less than 30 percent).
• Post-surgical septic infectious condition.
• Clinically significant anemia with hemoglobin values below 100g/l.
• 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.
• Participants enrolled in another clinical trial testing.

Sponsors & Collaborators

• M2RLAB SL: lead

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, Catalonia, 08036, Spain

RECRUITING

Related Publications (2)

• Jativa S, Torrico S, Calle P, Munoz A, Garcia M, Larque AB, Poch E, Hotter G. NGAL release from peripheral blood mononuclear cells protects against acute kidney injury and prevents AKI induced fibrosis. Biomed Pharmacother. 2022 Sep;153:113415. doi: 10.1016/j.biopha.2022.113415. Epub 2022 Jul 18.

  PMID: 36076483 BACKGROUND

• Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713.

  PMID: 17331245 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Esteban Poch López de Briñas

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pablo García de la Riva Mestre

CONTACT

+34 91 4213443; pgarciadelariva@m2rlab.com

Xavier Ginesta Buch

CONTACT

+34 91 4213443; xginesta@m2rlab.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be assigned to one of the two treatment groups in a 1:1 ratio. In both groups an intravenous injection will be administered to maintain the blinding of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: December 14, 2025
• Primary Completion (Estimated): June 17, 2027
• Study Completion (Estimated): September 2, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)