A Study of Cell Therapy for Subjects With Acute Kidney Injury Who Are Receiving Continuous Renal Replacement Therapy

Acute Kidney Injury Clinical Trial

Official title:

A Multi-center, Randomized, Sham-controlled, Double-blind, Ascending-dose Study of Extracorporeal Mesenchymal Stromal Cell Therapy (SBI-101 Therapy) in Subjects With Acute Kidney Injury Receiving Continuous Renal Replacement Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03015623
• Other study ID #: SBI-101-01
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: June 20, 2017
• Est. completion date: December 2021

Study information

• Verified date: March 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 Acute Kidney Injury (AKI) who require continuous renal replacement therapy. SBI-101 is a biologic/device combination product designed to regulate inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal cells.

The study will be conducted in two cohorts, with an interim analysis performed in between the cohorts. In the first cohort, subjects will be randomized to receive one of two treatments - low dose SBI-101 or sham control. In the second cohort, subjects will be randomized to receive one of two treatments - high dose SBI-101 or sham control. SBI-101 or sham control will be integrated into the renal replacement circuit and subjects in both cohorts will be treated for up to 24 hours.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• AKI, as determined by the Investigator based on his/her clinical judgment

• Able to tolerate indwelling intravascular access

• Has tolerated Continuous Renal Replacement Therapy for at least 12 hours prior to IP treatment

• Likely to require Continuous Renal Replacement Therapy for at least an additional 48 hours

• Ability to give informed consent

Exclusion Criteria:

• Female subjects who are pregnant, planning to become pregnant, or lactating

• Known end-stage liver disease

• Hepatorenal syndrome

• Acute glomerulonephritis (e.g. rapidly progressive glomerulonephritis; membranoproliferative glomerulonephritis; post-streptococcal glomerulonephritis); acute interstitial nephritis (e.g. toxin- or drug- induced interstitial nephritis) or hereditary renal disease (e.g. Alport's Syndrome; polycystic kidney disease)

• AKI due to post-renal outflow obstruction

• Acute or chronic vasculitis of any etiology

• At the time of randomization, clinical evidence (e.g. febrile) suggestive of an uncontrolled or inadequately treated systemic infection

• History of a chronic systemic infection of any etiology regardless of therapy

• 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

• Systemic immunosuppressive therapy that has not been stabilized for greater than 4 months, or in the case of chronic corticosteroid therapy, a dose of >15 mg/day of prednisone or the equivalent within the past 30 days

• Organ failure affecting more than 2 non-renal organs

• Platelet count <25,000/uL or other serious hematological abnormalities that would place subject in imminent danger of death

• Any prior medical condition 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
• 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.

Device:
• Sham
The sham control is an FDA-approved plasmapheresis device, without MSCs, which is integrated into a Continuous Renal Replacement Therapy circuit.

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital	Allentown	Pennsylvania

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 out to Day 28 and Serious Adverse Events through Day 180