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

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$773,285.00
Award Year:
2012
Program:
SBIR
Phase:
Phase II
Contract:
2R44DK085766-03
Agency Tracking Number:
R44DK085766
Solicitation Year:
2012
Solicitation Topic Code:
NIDDK
Solicitation Number:
PA11-096
Small Business Information
SENTIEN BIOTECHNOLOGIES, INC.
196 Boston Ave, Medford, MA, 02155
Hubzone Owned:
N
Socially and Economically Disadvantaged:
N
Woman Owned:
N
Duns:
828970900
Principal Investigator:
ARNO TILLES
(617) 724-2953
arno.tilles@sentienbiotech.com
Business Contact:
BRIAN MILLER
(781) 361-9031
brian.miller@sentienbiotech.com
Research Institution:
Stub




Abstract
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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