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

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Acute Kidney Injury

In brief

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).

Key facts

Study ID

NCT06654193

Run by

Hope Biosciences LLC

People needed

70

Starts

2026-02-01

Expected to finish

2028-01-01

Last updated by the study team

2026-03-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Texas Health Science Center at Houston (UTHealth Houston) — Houston, Texas, United States (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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