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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04445220
• Other study ID #: SBI-101-02
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: November 19, 2020
• Est. completion date: September 2022

Study information

• Verified date: August 2021
• Source: Sentien Biotechnologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: September 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• COVID-19
• Sepsis
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	University of New Mexico School of Medicine	Albuquerque	New Mexico
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sentien Biotechnologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability as measured by incidence of IP-related serious adverse events		Outcomes and Serious Adverse Events through Day 180