Status:
UNKNOWN
A Study of Cell Therapy in COVID-19 Subjects With Acute Kidney Injury Who Are Receiving Renal Replacement Therapy
Lead Sponsor:
Sentien Biotechnologies, Inc.
Conditions:
COVID-19
Acute Kidney Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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/...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04445220
Start Date
November 19 2020
End Date
September 1 2022
Last Update
January 14 2022
Active Locations (2)
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1
University of New Mexico School of Medicine
Albuquerque, New Mexico, United States, 87106
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29407