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NOT YET RECRUITING
NCT07052513
PHASE2

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

Sponsor: M2RLAB SL

View on ClinicalTrials.gov

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 patients 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2025-07-17

Completion Date

2027-09-02

Last Updated

2025-07-09

Healthy Volunteers

No

Interventions

DRUG

Placebo

Intravenous infusion of normal saline.

DRUG

M2RLAB 001

Intravenous infusion of M2RLAB 001

Locations (2)

Hospital Univ. Virgen del Rocío

Seville, Andalusia, Spain

Hospital Clinic of Barcelona

Barcelona, Catalonia, Spain