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Modified Autologous Leukocyte Cells for the Treatment of Acute Kidney Injury After Cardiac Surgery
Sponsor: M2RLAB SL
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
Conditions
Interventions
Placebo
Intravenous infusion of normal saline.
M2RLAB 001
Intravenous infusion of M2RLAB 001
Locations (2)
Hospital Univ. Virgen del Rocío
Seville, Andalusia, Spain
Hospital Clinic of Barcelona
Barcelona, Catalonia, Spain