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

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

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