Clinical trial NCT04445220: A Study of Cell Therapy in COVID-19 Subjects With Acute Kidney Injury Who Are Receiving Renal Replacement Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: COVID-19
Acute Kidney Injury
Sepsis
Keywords: CRRT
AKI
Continuous renal replacement therapy
MSC
Mesenchymal stromal cells
Mesenchymal stem cells
Stem cells
Cell therapy
Lead sponsor: Sentien Biotechnologies, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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/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 \<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

Primary outcomes:
measure: Safety and tolerability as measured by incidence of IP-related serious adverse events
timeFrame: Outcomes and Serious Adverse Events through Day 180
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico School of Medicine
state: New Mexico
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: