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



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Hospital
Therapuetic Areas:Nephrology / Urology, Other
Healthy:No
Age Range:18 - Any
Updated:9/8/2018
Start Date:June 20, 2017
End Date:December 2018
Contact:Brian Miller
Email:brian.miller@sentienbiotech.com
Phone:781-361-9031

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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

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.


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
We found this trial at
1
site
1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
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mi
from
Allentown, PA
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