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

Launched by M2RLAB SL · Jun 26, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment for people who develop sudden kidney problems, called Acute Kidney Injury (AKI), after heart surgery. The treatment uses special cells taken from the patient’s own white blood cells, which have been modified to help the kidneys recover faster. Researchers want to find out if this cell therapy helps the kidneys heal more quickly compared to a placebo (a harmless substance that looks like the treatment but has no active medicine). They will also closely watch to see if the treatment is safe and if it causes any side effects.

The study is for adults over 18 years old who are having planned heart valve or coronary artery surgery and who have a moderate or higher chance of developing kidney problems after surgery. To join, participants must show signs of AKI within 48 hours after their surgery, based on specific blood and urine tests. People with very advanced kidney disease, recent kidney injury, or certain infections and conditions are not eligible. If you take part, you will receive either the cell therapy or the placebo and be monitored to see how well your kidneys recover and whether you experience any medical issues. This trial is not yet recruiting, but it aims to offer a new option to improve recovery for patients facing kidney complications after heart surgery.

Gender

ALL

Eligibility criteria

• 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. Present pre-operative AKI risk more or equal to 30 percent according to the Leicester Cardiosurgery scale.
• 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 patient 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 therapy.
• • 4. Participants who are scheduled to start renal replacement therapy within the next 72 hours.
• • 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. Positive serology for hepatitis C virus (HCV), hepatitis B virus antigen (HBSAg), human immunodeficiency virus (HIV) or syphilis (by VDRL/TP: Venereal Disease Research Laboratory/Treponema pallidum). This criterion will be assessed once it has been confirmed that the patient has developed AKI.
• • 14. Participants enrolled in another clinical trial testing.