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

Open to people ages 18-75

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.

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