Sentien Biotechnologies Partners with BARDA to Evaluate High Dose Cohort in Phase 1/2 Trial of SBI-101 for Treatment of Acute Kidney Injury Associated with Sepsis
Excerpt from the Press Release:
Collaboration Under BARDA DRIVe Solving Sepsis Program to also Support Key Regulatory Path Activities to Advance Development of SBI-101
Sentien Biotechnologies, Inc., a clinical-stage biotechnology company developing novel approaches to cell therapy, today announced a partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, to evaluate Sentien’s ex vivo cell therapy, SBI-101, in patients suffering from acute kidney injury (AKI) associated with sepsis. This patient population includes COVID-19 patients with sepsis-AKI.
The BARDA-Sentien collaboration will enable evaluation of high dose SBI-101 therapy for the first time and support regulatory path activities to advance its development for the treatment of sepsis.
SBI-101 is a combination product that integrates allogeneic mesenchymal stromal cells (MSCs) within an extracorporeal, blood-contacting device. MSCs are a unique source of therapeutic secreted factors that modulate the immune-mediated inflammatory response to acute organ injury. By keeping the MSCs confined within a blood-contacting device, SBI-101 enables controlled, dynamic, and sustained delivery of MSC-secreted factors to the patient’s blood, without the need for direct injection of the MSCs themselves. SBI-101 integrates into a standard blood circuit such as used with renal replacement therapy, thereby providing patients with both standard-of-care and MSC-mediated blood conditioning in a single session.
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