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

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ClinicalTrials.gov Identifier: NCT03015623
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Sentien Biotechnologies, Inc.

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). SBI-101 is a biologic/device combination product designed to regulate inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal cells. Patients will be randomized to receive one of three treatments, low dose SBI-101, high dose SBI-101, or sham control. SBI-101 will be integrated into the renal replacement circuit and patients will be treated for up to 24 hours.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Biological: SBI-101 Device: Sham Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 20, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Low dose cohort
SBI-101 device containing 250 million MSCs
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.

Experimental: High dose cohort
SBI-101 device containing 750 million MSCs
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.

Sham Comparator: Control
Sham device containing no MSCs
Device: Sham
The sham control is an FDA-approved plasmapheresis device, without MSCs, which is integrated into a Continuous Renal Replacement Therapy circuit.




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015623


Contacts
Contact: Brian Miller 781-361-9031 brian.miller@sentienbiotech.com

Locations
United States, Pennsylvania
Lehigh Valley Hospital Recruiting
Allentown, Pennsylvania, United States, 18101
Sponsors and Collaborators
Sentien Biotechnologies, Inc.
Investigators
Study Chair: Brian Miller Sentien Biotechnologies, Inc.

Responsible Party: Sentien Biotechnologies, Inc.
ClinicalTrials.gov Identifier: NCT03015623     History of Changes
Other Study ID Numbers: SBI-101-01
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Sentien Biotechnologies, Inc.:
Mesenchymal stromal cells
MSC
Stem cells
Mesenchymal stem cells

Additional relevant MeSH terms:
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases