RecruitingPhase 1Phase 2NCT06654193

Allogeneic HB-adMSCs vs Placebo for the Treatment of Acute Kidney Injury

Allogeneic Adipose-derived Mesenchymal Stem Cells (MSC) for Acute Kidney Injury After Trauma or Burn

Sponsor

Hope Biosciences LLC

Enrollment

70 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Acute Kidney Injury

Summary

This study aims to investigate, through the collection of valid scientific evidence necessary to determine safety and effectiveness, the potential use of Allogeneic Hope Biosciences Adipose-derived Mesenchymal Stem Cells (HB-adMSCs) to prevent progression of trauma-induced Acute Kidney Injury (AKI).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

Between 18 and 75 years old AND
Diagnosed with Modified KDIGO Stage 2 AKI within the first 10 days after injury AND
Admitted to Intensive Care Unit or Intermediate Medical Unit AND
Received at least 3 units of any blood product within 6 hours of admission for trauma OR 15% or greater burn area OR any electrical burn OR any crush injury AND
Expected to survive at least 24 hours after diagnosis of KDIGO Stage 2 AKI AND
Patient or patient's Legally Authorized Representative (LAR) has voluntarily signed the informed consent.

Exclusion Criteria13

Patients are ineligible if they meet ONE OR MORE of the following:
Incarcerated individuals
Pregnant and lactating females
TBI deemed non-survivable by the trauma or neurosurgery attending physician
Hemodynamically unstable and requiring vasopressors for blood pressure support (systolic blood pressure ≥90 mmHg) during the 30-minute period prior to investigational product (IP) thawing/preparation
Pre-existing chronic kidney disease or acute kidney failure.
Pre-existing chronic liver disease.
Known immunodeficiency or concurrent use of potentially immunosuppressive medications at doses likely to result in an immunosuppressed status.
Active malignancy.
Known allergy to dimethyl sulfoxide or human serum albumin.
No available intravenous access (peripheral or central) of at least 22-gauge needle that can be utilized exclusively for IP during the time of planned infusion.
Clinical condition that would be anticipated to deteriorate with IV administration of 250 ml of crystalloid.
Known Do Not Resuscitate (DNR) prior to randomization