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 advancing towards 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). The device 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 critical components of a administering a new drug, namely (i) initiation time, (i) dose, and (iii) duration of treatment that will enable human investigation.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44DK085766-03
Application #
8251784
Study Section
Special Emphasis Panel (ZRG1-DKUS-L (11))
Program Officer
Moxey-Mims, Marva M
Project Start
2010-06-15
Project End
2014-06-30
Budget Start
2012-07-15
Budget End
2014-06-30
Support Year
3
Fiscal Year
2012
Total Cost
$773,285
Indirect Cost
Name
Sentien Biotechnologies, Inc.
Department
Type
DUNS #
828970900
City
Medford
State
MA
Country
United States
Zip Code
02155