RecruitingPhase 1/2

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

United States70 participantsStarted 2026-02-01

Plain-language 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).

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Incidence of infusion-related adverse events (AEs) or serious adverse events (SAEs)

Timeframe: 1 year

Duration of Acute Kidney Injury (AKI) at Stage 2

Timeframe: 2 days

Trial details

NCT IDNCT06654193

SponsorHope Biosciences LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-01-01

Contact for this trial

Charles S Cox, Jr., MD

713-500-7307 Charles.S.Cox@uth.tmc.edu

View on ClinicalTrials.gov More Acute Kidney Injury trials