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

• ClinicalTrials.gov Identifier: NCT03015623
• Recruitment Status: Active, not recruiting
• First Posted: January 10, 2017
• Last Update Posted: August 3, 2020
• Sponsor: Sentien Biotechnologies, Inc.
• Information provided by (Responsible Party): Sentien Biotechnologies, Inc.

Tracking Information

• First Submitted Date: January 6, 2017
• First Posted Date: January 10, 2017
• Last Update Posted Date: August 3, 2020
• Actual Study Start Date: June 20, 2017
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 6, 2017): Safety and tolerability as measured by incidence of IP-related serious adverse events [ Time Frame: Outcomes out to Day 28 and Serious Adverse Events through Day 180 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Acute Kidney Injury

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.

Study Arms

• Experimental: Low dose cohort
  SBI-101 device containing 250 million MSCs
  Intervention: Biological: SBI-101
• Experimental: High dose cohort
  SBI-101 device containing 750 million MSCs
  Intervention: Biological: SBI-101
• Sham Comparator: Control
  Sham device containing no MSCs
  Intervention: Device: Sham

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: January 6, 2017): 24
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2020
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03015623
• Other Study ID Numbers: SBI-101-01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Sentien Biotechnologies, Inc.
• Study Sponsor: Sentien Biotechnologies, Inc.
• Collaborators: Not Provided

Investigators

• Study Chair: Brian Miller; Sentien Biotechnologies, Inc.

• PRS Account: Sentien Biotechnologies, Inc.
• Verification Date: July 2020