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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Texas Health Science Center at Houston (UTHealth Houston)
  Houston, Texas, United States Recruiting
• 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

Study contacts

• Principal investigator: Charles S Cox, Jr., MD — The University of Texas Health Science Center, Houston
• Study coordinator: Charles S Cox, Jr., MD
• Email: Charles.S.Cox@uth.tmc.edu
• Phone: 713-500-7307

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.