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A Mesenchymal Stem Cell Bioreactor for the Active Treatment of Acute Renal…

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
96031
Program Year/Program:
2010 / SBIR
Agency Tracking Number:
DK085766
Solicitation Year:
N/A
Solicitation Topic Code:
NIDDK
Solicitation Number:
N/A
Small Business Information
SENTIEN BIOTECHNOLOGIES, INC.
196 Boston Ave Medford, MA 02155
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2010
Title: A Mesenchymal Stem Cell Bioreactor for the Active Treatment of Acute Renal Failur
Agency: HHS
Contract: 1R43DK085766-01
Award Amount: $565,011.00
 

Abstract:

DESCRIPTION (provided by applicant): The overall goal of this Phase I project is to create technical protocols for the reproducible operation of our proprietary cell-based device for the treatment of acute renal failure. The project specific aims are: (1) To identify active therapeutic secreted factors from MSCs in order to develop quality control assays; and (2) To optimize standard operating procedures for the manufacturing of MSC-devices and perform a dose escalation trial in dogs. The deliverable of thi s completed project will be a prototype cell-laden dialysis cartridge that will be ready for therapeutic testing in large animal and human trials during Phase II funding. PUBLIC HEALTH RELEVANCE: Sentien Biotechnologies Inc. has developed a cell -based kidney dialysis device that offers unparalleled support to patients undergoing acute renal failure. The device, known as the Sentinel , delivers cell- derived secretions of anti-inflammatory and regenerative molecules directly into the bloodstream i n a dynamic and sustained manner. This immunomodulatory and organ sparing approach distinguishes this device from current devices designed to provide artificial kidney support and promises to quickly become a disruptive technology in the realm of renal fai lure therapy. Sentien now seeks funding to continue to develop a pre-clinical pathway to commercialization of their proprietary technology. This pathway will involve an initial phase of identifying the key molecules secreted by MSCs for quality control pur poses and then the creation of standard operating procedures that optimize the viability and secretions of MSCs during bioproccessing of a human scale device. A dose escalation study will be performed in dogs using the manufacturing protocols created for t he Sentinel . A second phase of development will involve therapeutic trials in large animals and the clinical preparation and testing of the Sentinel in a Phase I/II human trial.

Principal Investigator:

Biju Parekkadan
6173987155
BIJU.PAREKKADAN@GMAIL.COM

Business Contact:

Brian Miller
brian.miller@sentienbiotech.com
Small Business Information at Submission:

SENTIEN BIOTECHNOLOGIES, INC.
SENTIEN BIOTECHNOLOGIES, INC. 196 Boston Ave Medford, MA -

EIN/Tax ID: 126378267
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No