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

Open to people ages 18-75

• Between 18 and 75 years old AND
• KDIGO Stage 2 AKI within the first 10 days after injury AND
• Admitted to ICU or Intermediate Medical Unit (IMU) 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

• Incarcerated individuals. Prisoners are excluded because of their vulnerable population status.
• Pregnant and lactating females. It is unknown how stem cells affect a developing fetus or if they can be found in milk. To protect the safety of developing fetuses and breast-feeding children, pregnant and lactating women will be excluded.
• Traumatic brain injury (TBI) deemed non-survivable by the trauma or neurosurgery attending physician
• Hemodynamically unstable and requiring vasopressors for blood pressure support (Systolic Blood Pressure (SBP) ≥ 90 mmHg) during the 30-minute period prior to Investigational Product (IP) thawing/preparation.
• Pre-existing Chronic Kidney Disease (CKD). Patients who are unable to communicate their pre-existing conditions will be excluded by Medical Alert bracelets/IDs, stigmata pathognomonic for CKD such as presence of dialysis vascular access devices or shunts or markedly elevated BUN/creatinine, or abdominal incisions consistent with organ transplantation
• 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 that can be utilized exclusively for IP during the time of planned infusion
• Clinical condition that would be anticipated to deteriorate with Intravenous (IV) administration of 250 ml of crystalloid
• Dialysis for chronic renal failure
• Known Do Not Resuscitate (DNR) prior to randomization