Mesenchymal Stem Cell Bioreactor for the Active Treatment of Acute Renal Failure

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44DK085766-03
Agency Tracking Number: R44DK085766
Amount: $773,285.00
Phase: Phase II
Program: SBIR
Awards Year: 2012
Solicitation Year: 2012
Solicitation Topic Code: NIDDK
Solicitation Number: PA11-096
Small Business Information
196 Boston Ave, Medford, MA, 02155
DUNS: 828970900
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (617) 724-2953
Business Contact
Phone: (781) 361-9031
Research Institution
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.

* Information listed above is at the time of submission. *

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