Sentien Biotechnologies, Inc. — Department of Health and Human Services SBIR Phase II: DESCRIPTION (provided by applicant): The overall goal of this project is to design a clini
Sentien Biotechnologies, Inc. — SBIR Phase II award from Department of Health and Human Services.
- Amount
- $773,285
- Agency
- Department of Health and Human Services · National Institutes of Health
- Program / Phase
- SBIR · Phase II
- Solicitation
- PA11-096
- NAICS
- —
- Place of performance
- MA
- Period
- — → 2018-07-31
Description
DESCRIPTION (provided by applicant): The overall goal of this project is to design a clinical protocol for the operation and monitoring of a mesenchymal stem cell (MSC)-coated dialysis device for the treatment of acute renal failure (ARF) in dogs. The project specific aims are: (1) Biomarker-guided initiation of Sentinel therapy in an ARF dogs. (2) Execute a dose escalation trial of the Sentinel in ARF dogs. The deliverable of this completed project will be an IND-ready device therapy that will be advancingtowards a Phase I clinical study. PUBLIC HEALTH RELEVANCE: Sentien Biotechnologies, Inc. has developed a mesenchymal stem cell (MSC)-coated device that offers combinatorial therapeutic support to patients undergoing acute renal failure (ARF). Thedevice delivers MSC-derived secretions of anti-inflammatory and regenerative molecules directly into the bloodstream in a dynamic and sustained manner. We now plan to develop an effective clinical protocol for the device for ARF that captures the criticalcomponents of a administering a new drug, namely (i) initiation time, (i) dose, and (iii) duration of treatment that will enable human investigation.