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

Sponsor
M2RLAB SL
Study ID
NCT07052513
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Kidney Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Intravenous infusion of normal saline.
  • M2RLAB 001 — DRUG
    Intravenous infusion of M2RLAB 001

Study Details

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.

Key Dates

First listed
Jul 4, 2025
Start date
Dec 14, 2025
Status verified
May 2026
Primary completion
Jun 17, 2027
Completion
Sep 2, 2027

Study Design

Enrollment
98 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Saline Solution for injection
    Participants randomized to placebo will receive a single 10 mL dose Intravenous (IV) infusion of normal saline (0.9 percent) no later than 48 hours after the participant's diagnosis of AKI.
  • Experimental: Cell therapy with leukocyte cells from the participant himself/herself
    Participants randomized to experimental group will receive a single 10 mL dose IV of leukocyte cells concentration of 6-15.4 x10\^6 cells/mL no later than 48 hours after the participant's diagnosis of AKI.

Primary Outcome Measure

Recovery time of kidney function [ Time Frame: Baseline Phase (Day 0), Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment) ]

Central Contacts

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