Actively Recruiting
Modified Autologous Leukocyte Cells for the Treatment of Acute Kidney Injury After Cardiac Surgery
Led by M2RLAB SL · Updated on 2026-05-12
98
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Modified Autologous Leukocyte Cells for the Treatment of Acute Kidney Injury After Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants older than 18 years who can understand and sign informed consent
- Undergoing elective valvular and/or coronary cardiac surgery with extracorporeal circulation
- Either have a pre-operative AKI risk of 30% or higher by the Leicester Cardiosurgery scale or have signed informed consent within 12 hours after AKI diagnosis
- Developed acute kidney injury within 48 hours after cardiac surgery as defined by AKIN 1, 2, or 3 criteria
- Women and men of childbearing age must agree to use contraception from hospital discharge until study end
You will not qualify if you...
- Chronic kidney disease stage IV or V with glomerular filtration rate less than 30 ml/min
- AKI within one month before heart surgery
- Previous renal replacement therapy
- Planned renal replacement therapy within 48 hours after AKI diagnosis due to clinical condition
- Interstitial glomerulonephritis or vasculitis
- Pregnancy or breastfeeding
- History of kidney transplant
- Endocarditis
- Use of mechanical assistance devices such as ECMO, LVAD, RVAD, or intra-aortic balloon pumps
- Severe ventricular dysfunction with ejection fraction less than 30%
- Post-surgical septic infection
- Clinically significant anemia with hemoglobin below 100 g/l
- Positive tests for hepatitis C, hepatitis B, HIV, or syphilis after AKI diagnosis confirmation
- Currently enrolled in another clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Clinic of Barcelona
Barcelona, Catalonia, Spain, 08036
Actively Recruiting
Research Team
P
Pablo García de la Riva Mestre
CONTACT
X
Xavier Ginesta Buch
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here