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

Purpose

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.

Conditions

  • COVID-19
  • Acute Kidney Injury
  • Sepsis

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Low dose cohort 		SBI-101 device containing 250 million MSCs
  • Biological: SBI-101
    SBI-101 is a biologic/device combination product that combines two components: allogeneic human mesenchymal stromal cells (MSCs) and an FDA-approved plasmapheresis device. SBI-101 is administered via integration into a Continuous Renal Replacement Therapy circuit and is designed to regulate inflammation and promote repair of injured tissue.
Experimental
High dose cohort 		SBI-101 device containing 750 million MSCs
  • Biological: SBI-101
    SBI-101 is a biologic/device combination product that combines two components: allogeneic human mesenchymal stromal cells (MSCs) and an FDA-approved plasmapheresis device. SBI-101 is administered via integration into a Continuous Renal Replacement Therapy circuit and is designed to regulate inflammation and promote repair of injured tissue.
No Intervention
Case controls 		Case control subjects will receive only standard-of-care treatment and will be followed for the same safety assessments as active study participants.

Recruiting Locations

More Details

NCT ID
NCT04445220
Status
Unknown status
Sponsor
Sentien Biotechnologies, Inc.