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

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$565,011.00
Award Year:
2010
Program:
SBIR
Phase:
Phase I
Contract:
1R43DK085766-01
Award Id:
96031
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, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
828970900
Principal Investigator:
BIJU PAREKKADAN
(617) 398-7155
BIJU.PAREKKADAN@GMAIL.COM
Business Contact:
BRIAN MILLER
() -
brian.miller@sentienbiotech.com
Research Institution:
n/a
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.

* information listed above is at the time of submission.

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