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

NCT03015623 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: SBI-101-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Mesenchymal stromal cells; MSC; Stem cells; Mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

• 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

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

Control

SHAM COMPARATOR

Sham device containing no MSCs

Device: Sham

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

Sham DEVICE

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

Control

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sentien Biotechnologies, Inc.: lead

Study Sites (1)

Lehigh Valley Hospital

Allentown, Pennsylvania, 18101, United States

Location

Related Publications (1)

• 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.

  PMID: 34581517 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Brian Miller

  Sentien Biotechnologies, Inc.

  STUDY CHAIR

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: January 6, 2017
• First Posted: January 10, 2017
• Study Start: June 20, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)