Clinical Trials

We are conducting a Phase I/II clinical study of SBI-101 in critically ill patients with Dialysis-Requiring Acute Kidney Injury (AKI-D).

Image courtesy NIH

Initial Indication: Dialysis-Requiring Acute Kidney Injury

Sentien is currently recruiting patients into its first SBI-101 clinical trial for Dialysis-Requiring Acute Kidney Injury (AKI-D). The study is a randomized, sham-controlled, double-blinded, sequential dose escalation study in subjects with acute kidney injury requiring dialysis.

AKI is a sudden loss of kidney function and can lead to systemic inflammatory response syndrome (SIRS), multi-organ failure and death. Patients diagnosed with severe AKI are placed on dialysis, require extensive stays in the ICU and have mortality rates of 50-70%. It is the single most expensive diagnosis among hospital inpatients. Those who survive the acute phase of injury are at significant risk of requiring a kidney transplant and/or life-long dialysis.

Single factor interventions have shown to be ineffective for AKI because they fail to address the multi-factorial pathophysiology of the disease. With dialysis as the only therapeutic option for these patients, there is an urgent need for a therapy that can simultaneously address the many complex disease processes associated with severe AKI and reduce the significant morbidity and mortality rates associated with this disease.

To treat AKI patients, SBI-101 integrates seamlessly into a continuous renal replacement therapy (CRRT) circuit and delivers MSC-secreted factors directly to the bloodstream of patients. This design provides AKI patients with both hemofiltration and active stem cell therapy in a single session and requires minimal changes to existing dialysis equipment and protocols for ICU staff. Early clinical data has confirmed sustained patient exposure to MSC secreted factors over a 24-hour treatment period and provided evidence that the MSCs are dynamically responding to inflammatory stimuli in blood.