SBI-101 / Sentien Biotech - LARVOL DELTA

A Study of Cell Therapy in COVID-19 Subjects With Acute Kidney Injury Who Are Receiving Renal Replacement Therapy (clinicaltrials.gov) - P1/2; N=22; Active, not recruiting; Sponsor: Sentien Biotechnologies, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Acute Kidney Injury • Infectious Disease • Nephrology • Novel Coronavirus Disease • Renal Disease • Septic Shock

Pharmacological effects of ex vivo mesenchymal stem cell immunotherapy in patients with acute kidney injury and underlying systemic inflammation. (PubMed, Stem Cells Transl Med) - "Although the study was not powered for clinical efficacy, these results are supportive of the therapeutic hypothesis, namely, that treatment with SBI-101 elicits an immunotherapeutic response that triggers an accelerated phenotypic switch from tissue injury to tissue repair. Ex vivo administration of MSCs, with increased power of testing, is a potential new biological delivery paradigm that assures sustained MSC activity and immunomodulation."

Journal • Preclinical • Acute Kidney Injury • Immune Modulation • Immunology • Inflammation • Nephrology • Renal Disease

A Study of Cell Therapy in COVID-19 Subjects With Acute Kidney Injury Who Are Receiving Renal Replacement Therapy (clinicaltrials.gov) - P1/2; N=22; Recruiting; Sponsor: Sentien Biotechnologies, Inc.; Trial completion date: Dec 2021 ➔ Sep 2022; Trial primary completion date: Jun 2021 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date • Acute Kidney Injury • Infectious Disease • Nephrology • Novel Coronavirus Disease • Renal Disease • Septic Shock

A Study of Cell Therapy for Subjects With Acute Kidney Injury Who Are Receiving Continuous Renal Replacement Therapy (clinicaltrials.gov) - P1/2; N=24; Active, not recruiting; Sponsor: Sentien Biotechnologies, Inc.; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Acute Kidney Injury • Nephrology • Renal Disease

A Study of Cell Therapy in COVID-19 Subjects With Acute Kidney Injury Who Are Receiving Renal Replacement Therapy (clinicaltrials.gov) - P1/2; N=22; Recruiting; Sponsor: Sentien Biotechnologies, Inc.; Trial completion date: Jul 2021 ➔ Dec 2021; Trial primary completion date: Feb 2021 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Acute Kidney Injury • Infectious Disease • Nephrology • Novel Coronavirus Disease • Renal Disease

A Study of Cell Therapy in COVID-19 Subjects With Acute Kidney Injury Who Are Receiving Renal Replacement Therapy (clinicaltrials.gov) - P1/2; N=22; Recruiting; Sponsor: Sentien Biotechnologies, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Acute Kidney Injury • Infectious Disease • Nephrology • Novel Coronavirus Disease • Renal Disease

[VIRTUAL] Clinical Relevance of AKI Trial Data for Severe COVID-19 Patients (KIDNEY WEEK 2020) - "Data obtained in our AKI-D trial showed modulation of many biological molecules and immune populations that may be correlated with severe COVID-19 immunopathology. Here we make the case, using our existing AKI-D trial data, that SBI-101 may be of therapeutic benefit to severe cases of COVID-19."

Clinical • Acute Kidney Injury • Acute Respiratory Distress Syndrome • Immunology • Infectious Disease • Inflammation • Nephrology • Novel Coronavirus Disease • Renal Disease • Respiratory Diseases • Transplantation • IFNG • TNFA

Sentien Biotechnologies Announces Open IND in Phase 1/2 Trial of SBI-101 for Patients with COVID-19 (PRWeb) - "Sentien Biotechnologies, Inc....today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational New Drug (IND) application for the evaluation of Sentien’s lead asset, SBI-101, for the treatment of severe COVID-19. Approval of this IND allows Sentien to initiate a Phase 1/2 study with a focus on COVID-19 patients suffering from both acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) requiring renal replacement therapy (RRT)."

Cytokine storm • IND • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease

A Study of Cell Therapy for Subjects With Acute Kidney Injury Who Are Receiving Continuous Renal Replacement Therapy (clinicaltrials.gov) - P1/2; N=24; Active, not recruiting; Sponsor: Sentien Biotechnologies, Inc.; Recruiting ➔ Active, not recruiting; Trial completion date: Dec 2018 ➔ Dec 2020; Trial primary completion date: Dec 2018 ➔ Dec 2020

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Acute Kidney Injury • Nephrology • Renal Disease