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

NCT04445220 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: SBI-101-02
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability as measured by incidence of IP-related serious adverse events

  Outcomes and Serious Adverse Events through Day 180

Study Arms (3)

Low dose cohort

EXPERIMENTAL

SBI-101 device containing 250 million MSCs

Biological: SBI-101

High dose cohort

EXPERIMENTAL

SBI-101 device containing 750 million MSCs

Biological: SBI-101

Case controls

NO INTERVENTION

Case control subjects will receive only standard-of-care treatment and will be followed for the same safety assessments as active study participants.

Interventions

SBI-101 BIOLOGICAL

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.

High dose cohort; Low dose cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sentien Biotechnologies, Inc.: lead

Study Sites (2)

University of New Mexico School of Medicine

Albuquerque, New Mexico, 87106, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29407, United States

Location

MeSH Terms

Conditions

COVID-19; Acute Kidney Injury; Sepsis

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: November 19, 2020
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2022
• Last Updated: January 14, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)