Clinical trial NCT03015623: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Kidney Injury
Keywords: Mesenchymal stromal cells
MSC
Stem cells
Mesenchymal stem cells
Lead sponsor: Sentien Biotechnologies, Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety and tolerability as measured by incidence of IP-related serious adverse events
timeFrame: Outcomes out to Day 28 and Serious Adverse Events through Day 180
Secondary outcomes:
Other outcomes:
Locations:
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
Study officials:
affiliation: Sentien Biotechnologies, Inc.
name: Brian Miller
role: STUDY_CHAIR
References:
citation: 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.