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.
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.
Brief Title
A Study of Cell Therapy for Subjects With Acute Kidney Injury Who Are Receiving Continuous Renal Replacement Therapy
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Acute Kidney Injury
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Mesenchymal stromal cells
MSC
Stem cells
Mesenchymal stem cells
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03015623
Org Class
Industry
Org Full Name
Sentien Biotechnologies, Inc.
Org Study Id
SBI-101-01
Overall Status
Unknown status
Phases
Phase 1
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome Measure
Safety and tolerability as measured by incidence of IP-related serious adverse events
Outcome Time Frame
Outcomes out to Day 28 and Serious Adverse Events through Day 180
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Neelja Kumar
Investigator Email
nekumar@montefiore.org
Investigator Phone