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

NCT07052513 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Placebo

Intravenous infusion of normal saline.

DRUG

M2RLAB 001

Intravenous infusion of M2RLAB 001

Sponsors & Collaborators

  • M2RLAB SL

    lead INDUSTRY

Principal Investigators

  • Esteban Poch López de Briñas · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-14
Primary Completion
2027-06-17
Completion
2027-09-02

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07052513 on ClinicalTrials.gov