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

A Multi-center, Randomized, Case Controlled, Double-blind, Ascending-dose Study of Extracorporeal Mesenchymal Stromal Cell Therapy (SBI-101 Therapy) in COVID-19 Subjects With Acute Kidney Injury Receiving Renal Replacement Therapy

The purpose of this study is to assess the safety and tolerability of the investigational product, SBI-101, in subjects with an infectious etiology of Acute Kidney Injury (AKI). SBI-101 is a biologic/device combination product designed to regulate inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal cells. SBI-101 will be integrated into the renal replacement circuit and patients will be treated for up to 24 hours.

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