Cellular Device for the Treatment of Acute Liver Failure

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43DK093285-01A1
Agency Tracking Number: R43DK093285
Amount: $499,306.00
Phase: Phase I
Program: SBIR
Awards Year: 2012
Solitcitation Year: 2012
Solitcitation Topic Code: NIDDK
Solitcitation 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
Email: brian.miller@sentienbiotech.com
Research Institution
DESCRIPTION (provided by applicant): The goal of this Phase I project is to develop a cell-coated device for the treatment of acute liver failure. The device harnesses mesenchymal stem cell secretions to provide combined anti-inflammatory and regenerativesupport. The project specific aims are: (1) Positron emission tomography (PET)-guided optimization of cellular coatings; and (2) To perform a dose escalation therapeutic trial in an acetaminophen-induced liver failure model in dogs. The deliverable of thiscompleted project will be therapeutic proof-of concept data that can be optimized in large animals during Phase II funding. PUBLIC HEALTH RELEVANCE: Biotechnologies Inc. has developed an extracorporeal device that has the potential to offer unparalleled support to patients undergoing acute liver failure. Th Sentien device delivers to the patient a broad-spectrum array of secreted factors from mesenchymal stem cells. Collectively, these factors protect the injured organ from inflammation and promote endogenous repair programs. This combinatorial approach to liver therapy is distinguishable from the competition and promises to become a disruptive technology. Sentien now seeks funding to finalize its pre-clinical development by creating optimized cellular coatings and performing subsequent in vivo testing in large animal models of liver failure. At the end of these studies, Sentien expects to have sufficient evidence of pre-clinical efficacy to motivate initial trials of this device in humans.

* information listed above is at the time of submission.

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