Using donor adipose-derived stem cells to prevent worsening after trauma-related acute kidney injury

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

This trial will test whether three doses of donated adipose-derived mesenchymal stem cells can prevent progression of moderate-to-severe trauma-related acute kidney injury in hospitalized adults.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hope Biosciences Research Foundation (Industry-sponsored)
• Locations: 3 sites (Birmingham, Alabama and 2 other locations)
• Trial ID: NCT06654193 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 1/2a trial that first confirms safety in a small Phase 1 cohort and then randomizes patients in Phase 2a. The intervention is three infusions of allogeneic HB-adMSCs given at 24-hour intervals over 72 hours, started when patients reach modified KDIGO Stage 2 or 3 AKI after trauma. Phase 1 enrolls 10 patients to confirm safety with the cryopreserved product, and Phase 2a randomizes about 60 patients 1:1 to HB-adMSCs or saline placebo to compare duration of Stage 2+ AKI. The main clinical outcome is the proportion of patients whose Stage 2 AKI lasts more than two days after treatment start.

Who should consider this trial

Good fit: Adults 18–75 who are in the ICU or intermediate unit with trauma-induced modified KDIGO Stage 2 AKI within 10 days of injury and who meet the trauma/burn/crush injury and transfusion criteria and can give consent or have a legally authorized representative may be eligible.

Not a fit: Patients who are pregnant or lactating, incarcerated, judged to have non-survivable traumatic brain injury, hemodynamically unstable on vasopressors, or otherwise outside the enrollment criteria are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the treatment could shorten the duration of severe AKI after trauma and reduce the need for dialysis and related complications.

How similar studies have performed: Mesenchymal stem cells have shown promise in animal models and small early human trials for kidney injury, but clear, reproducible clinical benefit for trauma-related AKI has not yet been established.

Eligibility criteria

Inclusion Criteria:

1. Between 18 and 75 years old AND
2. Diagnosed with Modified KDIGO Stage 2 AKI within the first 10 days after injury AND
3. Admitted to Intensive Care Unit or Intermediate Medical Unit AND
4. 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
5. Expected to survive at least 24 hours after diagnosis of KDIGO Stage 2 AKI AND
6. Patient or patient's Legally Authorized Representative (LAR) has voluntarily signed the informed consent.

Exclusion Criteria:

Patients are ineligible if they meet ONE OR MORE of the following:

1. Incarcerated individuals
2. Pregnant and lactating females
3. TBI deemed non-survivable by the trauma or neurosurgery attending physician
4. 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
5. Pre-existing chronic kidney disease or acute kidney failure.
6. Pre-existing chronic liver disease.
7. Known immunodeficiency or concurrent use of potentially immunosuppressive medications at doses likely to result in an immunosuppressed status.
8. Active malignancy.
9. Known allergy to dimethyl sulfoxide or human serum albumin.
10. 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.
11. Clinical condition that would be anticipated to deteriorate with IV administration of 250 ml of crystalloid.
12. Known Do Not Resuscitate (DNR) prior to randomization

Where this trial is running

Birmingham, Alabama and 2 other locations

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

Study contacts

• Principal investigator: Charles S Cox, Jr., MD — The University of Texas Health Science Center, Houston
• Study coordinator: Charles S Cox, Jr., MD

Conditions Acute Kidney Injury; acute kidney injury; stem cells; aki; hope biosciences