A Study of Cell Therapy in COVID-19 Subjects With Acute Kidney Injury Who Are Receiving Renal Replacement Therapy

Inclusion Criteria:

- Documented evidence of infection, e.g., positive PCR for COVID-19, positive blood
cultures for systemic infection, active urinary sediment to suggest UTI, or any
imaging supportive of a clinical diagnosis of infection, for example, pulmonary
infiltrate on chest x-ray to suggest pneumonia, pancreatitis on CT imaging, abdominal
collection, etc.

- AKI as determined by the Investigator based on his/her clinical judgment

- Receiving or planned to receive RRT in < 24 hours

- Able to tolerate indwelling intravascular access

- Has tolerated CRRT for at least 6 hours prior to IP treatment

- Have maintained hemodynamic stability for at least 6 hours prior to IP treatment with
only minor changes in pressure support medication required (if used)

- Vascular access (catheter placement) is patent and capable of supporting CRRT for the
duration of IP treatment

- Likely to require RRT for at least an additional 48 hours

- Potassium level >3.6 and <5.5 mEq/L or >3.6 and < 5.5 mmol/L prior to IP treatment

- SaO2 > 92% prior to IP initiation

- Blood pH > 7.2 prior to IP initiation

- Medically cleared to receive anticoagulation per institutional standard of care / PI
prescribed protocol and meeting protocol defined anticoagulation targets prior to
receipt of IP

- Ability to give informed consent or have a legally authorized representative do so

Exclusion Criteria:

- Female subjects who are pregnant, planning to become pregnant, or lactating

- MAP <70 mmHg immediately prior to IP initiation

- Systolic blood pressure < 90 mmHg immediately prior to IP initiation

- Mechanical ventilator support requiring FiO2 > 80% prior to IP initiation

- Receiving extracorporeal membrane oxygenation (ECMO)

- Liver disease with Child Pugh score of > 7 prior to IP initiation

- High sensitivity cardiac Troponin level (hs-cTn) > 100.0 ng/L prior to IP initiation
or other equivalent Troponin test result prior to IP initiation

- Hepatorenal syndrome

- AKI due to post-renal outflow obstruction

- Acute or chronic vasculitis of any etiology

- Chronic systemic infection

- Subjects with a past medical history of an inherited or acquired hypercoagulable
condition independent of COVID-19

- Patients with a past medical history of an allergic response to MSC therapy

- Participation in another interventional trial with the exception of studies of
antivirals, corticosteroids, hydroxychloroquine, azithromycin, or angiotensin
converting enzyme inhibitors/angiotensin receptor blockers (or related compounds)

- Active malignancy(-ies) and/or receiving active treatment for a malignancy(-ies), with
the exception of non-melanoma skin cancer

- Subjects, who in the opinion of the Investigator, are likely to require escalating
doses of vasopressors to attain and/or maintain hemodynamic stability, or subjects who
have reached the institutionally defined maximum level of vasopressor support within
12 hours of intended IP integration

- Imminent death in <24 hours

- Organ failure affecting more than 2 non-renal organs

- Platelet count <50,000/μL or other serious hematological abnormalities that would
place subject in imminent danger of death

- Lactate levels >8 mmol/L suggestive of severe end-organ hypoperfusion prior to the
time of IP integration

- Any prior medical condition or recent surgical procedure, planned significant medical
interventions or procedures that, in the judgment of the Investigator, would prevent
the subject from safely participating in and/or completing all study requirements