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

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.

Timeline

Start

2025-12-14

Primary completion

2027-06-17

Completion

2027-09-02

Publications

• Background 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.
• 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.

Drugs

Indications