drugset / Trial / NCT04445220

A Study of Cell Therapy in COVID-19 Subjects With Acute Kidney Injury Who Are Receiving Renal Replacement Therapy

NCT04445220 ↗

Phase 1/2 Unknown 22 enrolled Sentien Biotechnologies, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the safety and tolerability of the investigational product, SBI-101, in subjects with an infectious etiology of 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. SBI-101 will be integrated into the renal replacement circuit and patients will be treated for up to 24 hours.

Timeline

Start
2020-11-19
Primary completion
2022-03
Completion
2022-09

Drugs

EvaluationDrugModalityDoseRoute
Subject SBI-101 Cell therapy 250 cells Other
Subject SBI-101 Cell therapy 750 cells Other