a study of cell therapy in covid-19 subjects with acute kidney injury who are receiving renal replacement therapy

Conditions: COVID-19; Acute Kidney Injury; Sepsis

Summary: 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.


Eligibility criteria:
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 \ 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

Keywords: crrt aki continuous renal replacement therapy msc mesenchymal stromal cells mesenchymal stem cells stem cells cell therapy