Modified autologous leukocyte cells for the treatment of acute kidney injury after cardiac surgery

Phase 1

• Conditions: Acute kidney injury after cardiac surgery; MedDRA version: 26.0Level: PTClassification code: 10069339Term: Acute kidney injury Class: 100000004857; Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]; Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

• Registration Number: CTIS2023-504610-30-01
• Lead Sponsor: M2rlab S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-29
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

Patients of both sexes over 18 years of age being able to understand and sign the informed consent., Patients undergoing elective valvular and/or coronary heart surgery performed with extracorporeal circulation., Have a preoperative AKI risk = 30% according to the Leicester Cardiosurgery Scale., Have AKI (serum creatinine >50% increase from baseline) and a urine NGAL value of >200 microgram/g creatinine in the first 48h after cardiac surgery., In the case of women or men of childbearing age, for safety, those who agree to follow the required contraceptive measures from hospital discharge until the end of their participation in the clinical trial.

Exclusion Criteria

Stage IV or V CKD (glomerular filtration rate [GFR] < 30 ml/min), Known severe ventricular dysfunction (left ventricular ejection fraction [LVEF] <30%), Post-surgical septic infection., Participation in another clinical intervention trial., AKI in the month prior to cardiac surgery., Patients previously undergoing renal therapy., Patients who are scheduled to start renal replacement therapy in the following 72 hours, Interstitial glomerulonephritis or vasculitis., Pregnancy., History of renal transplant., Endocarditis., Patients with mechanical assist devices: extracorporeal membrane oxygenator (ECMO), left ventricular assist device (LVAD), right ventricular assist device (RVAD), intra-aortic balloon pumps (IABP).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified