NCT07052513

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: M2RLAB SL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase II, multi-center, randomized, placebo-controlled clinical trial, with 2 treatment arms and single blind. After being informed about the study, participants who meet the eligibility criteria will be randomized in 1:1 ratio to treatment with a single administration of cell therapy with leukocyte cells from the participant himself/herself or placebo (approximately 49 subjects per group). Acute kidney injury (AKI) is one of the main complications after cardiac surgery. In fact, AKI after cardiac surgery is associated with high morbidity and mortality. Currently, there are no effective therapies for kidney injury after cardiac surgery, but there is evidence that recovery is possible if the injury processes are overcome. Thus, due to the lack of preventive and therapeutic options at present, cell therapy has gained importance in recent years in different clinical trials. Thus, within this context, the use of modified leukocyte cells as cell therapy is also an alternative for the treatment of AKI due to their powerful immunomodulatory effect. On the other hand, the use of placebo is justified because there is currently no other pharmacological treatment available to serve as an active control. A placebo-controlled study is optimal to evaluate the efficacy and safety of an experimental treatment. Researchers hypothesized that cell therapy with autologous leukocyte cells can be safe, well tolerated and clinically beneficial versus placebo for participants who develop AKI within the first 48 hours after cardiac surgery. This study consists of 3 phases: the initial phase, the observation phase, and the follow-up phase. The total duration of each participant in the trial will be 3 months: * Initial phase: The patient undergoing cardiac surgery will sign the informed consent (IC) before the surgery (at a scheduled visit prior to his/her hospitalization or at the time of his/her hospitalization and prior to undergoing the procedure). As indicated in the Inclusion criteria, only participants who present AKI within the first 48 hours post cardiac surgery will be included. The participants who meet all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to one of the two study groups. A volume of at least 60 mL of peripheral blood will be extracted from the patient, from which the cell therapy will be prepared (in cases where the patient is included in the experimental group) The investigational product/placebo will be administered to the patient within 36 hours of AKI diagnosis. * Observation phase: It includes the period from when the patient receives the investigational drug/placebo until he or she is discharged from the hospital. This period lasts 16 to 20 days, depending on the clinical evolution of the participants. During this phase, participants will be followed and will undergo different tests in order to evaluate the effectiveness and safety of the investigational treatment vs. placebo. * Follow-up phase: It includes the period from when the patient receives hospital discharge and ends 90 days from the date of inclusion of the participant in the study. At this stage, participants will be monitored to evaluate the efficacy and safety of the experimental cell therapy drug vs. placebo.

Conditions

• Acute Kidney Injury

Interventions

Type	Name	Description
DRUG	Placebo	Intravenous infusion of normal saline.
DRUG	M2RLAB 001	Intravenous infusion of M2RLAB 001

Timeline

• Start date: 2025-07-17
• Primary completion: 2027-06-17
• Completion: 2027-09-02
• First posted: 2025-07-04
• Last updated: 2025-07-09

Locations

2 sites across 1 country: Spain