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

NCT ID: NCT03015623

Last Updated: 2021-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-20
• Study Completion Date: 2021-12-31

Brief 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.

Conditions

Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Low dose cohort

SBI-101 device containing 250 million MSCs

Group Type: EXPERIMENTAL

SBI-101

Intervention Type: 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

SBI-101 device containing 750 million MSCs

Group Type: EXPERIMENTAL

SBI-101

Intervention Type: 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.

Control

Sham device containing no MSCs

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: BIOLOGICAL

Sham

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sentien Biotechnologies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Miller

Role: STUDY_CHAIR

Sentien Biotechnologies, Inc.

Locations

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Countries

United States

References

Swaminathan M, Kopyt N, Atta MG, Radhakrishnan J, Umanath K, Nguyen S, O'Rourke B, Allen A, Vaninov N, Tilles A, LaPointe E, Blair A, Gemmiti C, Miller B, Parekkadan B, Barcia RN. Pharmacological effects of ex vivo mesenchymal stem cell immunotherapy in patients with acute kidney injury and underlying systemic inflammation. Stem Cells Transl Med. 2021 Dec;10(12):1588-1601. doi: 10.1002/sctm.21-0043. Epub 2021 Sep 28.

Reference Type: DERIVED

PMID: 34581517 (View on PubMed)

Other Identifiers

SBI-101-01

Identifier Type: -

Identifier Source: org_study_id