Could your own cells heal kidneys after heart surgery?
NCT ID NCT07052513
First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 1 time
Summary
This study tests whether a patient's own modified white blood cells can help kidneys recover faster after acute injury from heart surgery. About 98 adults will receive either the cell therapy or a placebo. The goal is to see if the treatment shortens recovery time and is safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- modified white blood cells (autologous leukocyte cells)
- What this could lead to
- If it works, this could offer a new treatment to help kidneys recover faster after heart surgery, reducing the need for dialysis.
- What could go wrong
- This is an early Phase 2 trial with only 98 participants, so results may not apply to everyone. The treatment involves infusing modified cells, which carries risks like infection or immune reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 98 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female participants older than 18 years of age, being able to understand and sign the Informed Consent. 2. Participants undergoing elective valvular and/or coronary cardiac surgery performed with extracorporeal circulation. 3. Participants must meet one of the following two criteria: 1. Present pre-operative AKI risk more or equal to 30 percent according to the Leicester Cardiosurgery scale, in case the participants had signed the IC before. 2. Participants that had signed the IC within 12 hours after the AKI diagnosis. 4. Present AKI within the first 48 hours post cardiac surgery in one of the following classifications defined by the AKIN scale (Acute Kidney Injury Network): AKIN 1: An increase in serum creatinine by at least 0.3 mg/dL (more or equal to 26.4 micromol/L) from baseline, or an increase to more or equal to 150-200 percent (corresponding to a 1.5- to 2-fold increase) from baseline. In addition, the participant must have a positive acute tubular necrosis score within the first 48 hours post cardiac surgery, defined as the presence of at least 3 of the following 4 scenarios: Sodium excretion fraction more than 2 percent, urinary osmolality lower than 400 mOsm/kg, urine sodium more than 40 mmol/L, presence of shock or nephrotoxic agents. AKIN 2: An increase in serum creatinine to more than 200 percent and up to a maximum of 300 percent (corresponding to an increase of more than 2 and up to 3 times) over baseline. AKIN 3: An increase in serum creatinine to more than 300 percent (corresponding to more than 3-fold increase) over baseline, or an increase in serum creatinine levels to more or equal to 4.0 mg/dl (more or equal to 354 micromol/l) with an acute increase of at least 0.5 mg/dl (44 micromol/l). 5. In the case of women or men of childbearing age, for safety, those who undertake to follow the contraceptive measures required from their discharge from hospital until the end of their participation in the clinical trial. Exclusion Criteria: 1. Chronic Kidney Disease (CKD) in stage IV or V (glomerular filtration rate \[GFR\] less than 30 ml/min). 2. AKI one month prior to heart surgery. 3. Participants who have previously undergone renal replacement therapy. 4. Participants who, due to their clinical situation (hemodynamic instability, oliguria, current or anticipated volume overload) are scheduled to start renal replacement therapy within the next 48 hours after AKI diagnosis. 5. Interstitial glomerulonephritis or vasculitis. 6. Pregnancy. 7. Women in breastfeeding period 8. Renal transplant history. 9. Endocarditis. 10. Participants with mechanical assistance devices: extracorporeal membrane oxygenation (ECMO), left ventricular assist device (LVAD), right ventricular assist device (RVAD), intra-aortic balloon pumps (IABP). 11. Known severe ventricular dysfunction (left ventricular ejection fraction \[LVEF\] less than 30 percent). 12. Post-surgical septic infectious condition. 13. Clinically significant anemia with hemoglobin values below 100g/l. 14. Positive serology for hepatitis C virus (HCV), hepatitis B virus antigen (HBSAg), human immunodeficiency virus (HIV) or syphilis (by RPR: Rapid Plasma Reagin). This criterion will be assessed once it has been confirmed that the participant has developed AKI. 15. Participants enrolled in another clinical trial testing.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Clinic of Barcelona
Barcelona, Catalonia, 08036, Spain
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