Abstract: SA-PO086
A Study of Cell Therapy for Subjects With AKI Who Are Receiving Continuous Renal Replacement Therapy
Session Information
- AKI Clinical: Biomarkers and Dialysis
November 04, 2017 | Location: Hall H, Morial Convention Center
Abstract Time: 10:00 AM - 10:00 AM
Category: Acute Kidney Injury
- 003 AKI: Clinical and Translational
Author
- Miller, Brian, Sentien Biotechnologies, Inc., Medford, Massachusetts, United States
Background
Sentien Biotechnologies, Inc. is developing SBI-101, a combination product containing allogeneic human mesenchymal stromal cells (MSCs) inoculated into a hollow-fiber unit for the treatment of patients with acute kidney injury (AKI) and the need for continuous renal replacement therapy (CRRT). MSCs are a unique source of therapeutic secreted factors that modulate the immune-mediated inflammatory response to acute organ injury and can enhance the repair of injured tissue.
SBI-101 therapy is a novel approach designed to overcome the limitations of infusion of MSCs via the utilization of an extracorporeal, blood-contacting device. By immobilizing the MSCs outside of the patient, SBI-101 therapy is designed to facilitate dynamic, continuous blood conditioning in patients undergoing severe organ injury, including AKI requiring CRRT, combining an active therapy with standard of care for these patients.
Methods
The study is a prospective, multi-center, randomized, double-blind, sham-controlled, study of subjects with a clinical diagnosis of AKI due to various etiologies who are receiving CRRT. Subjects must have tolerated CRRT for at least 12 hours after commencement of CRRT and at the time of randomization and treatment with SBI-101. Up to 32 subjects may be enrolled to provide 24 subjects evaluable (as a per protocol population).
-Low dose: (250 x106 MSCs) SBI-101 device
-High dose: (750 x 106 MSCs) SBI-101 device
-Control: Sham SBI-101 (no MSCs)
For the low and high dose cohorts, 8 subjects will receive active treatment and 4 subjects will receive sham control.
Results
This study is actively recruiting patients with results expected in 2018.
Conclusion
This first-in-human clinical trial will evalute the safety and tolerability of SBI-101 in patients with AKI requiring CRRT. The study will also measure renal efficacy parameters as well as exploratory biomarkers chosen to characterize the pharmacodynamic effect of SBI-101 in treated subjects.
Funding
- NIDDK Support –