SBIR/STTR Research Award

Transforming Dialysis into a Controlled Drug Delivery System for Stem Cell Derive

Award identifier 06246efcc628552daa4d3a296d0daf23f9e2e8a87f49637fbe4d2c6ab7f877a6Awarding agency Department of Health and Human Services · National Institutes of Health

Award amount

$2,985,949

Program and phase

SBIR · Phase II

Award year

2014

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Award details

Awarding agency
Department of Health and Human Services
Branch
National Institutes of Health
Recipient company
Sentien Biotechnologies, Inc.
Proposal award date
Not reported
Contract end date
Not reported
UEI
NDAYRDKCMBJ7
Solicitation number
PA13-088
Topic code
NIDDK

Research abstract

DESCRIPTION (provided by applicant): The goal of this Phase IIB SBIR application is to test the Sentien cellular bioreactor product (the Sentinel ) in a first-in-man study to assess safety and preliminary efficacy. Fifteen post-cardiac surgery patients that are diagnosed with acute kidney injury and indicated for dialysis will be enrolled and connected to the Sentinel containing one of three escalating doses of cells, n=5 per dose: 250M, 500M and 1000M. Primary endpoints involve measures of safety, and patient samples will be taken for analysis by Sentien to evaluate possible trends in efficacy. The project specific aims are: (1) conduct a single- center, open-label, dose escalation safety study of the Sentinel in cardiac surgery patients diagnosed with AKIand indicated for CVVH; (2) measure experimental urine biomarkers for preliminary monitoring of device efficacy; and (3) profile the inflammatory response pathway in paired testing of patient blood. The deliverables of this project will be (1) a recor

Technology keywords

Not reported

Other awards by this recipient

Verified by the same UEI. These are other public SBIR/STTR award pages, not a merged company record.

Awards with the same topic code

Verified by an exact topic code match. This is not a text-similarity match.

Research funding history

9 SBIR/STTR records share this UEI (2010–2016). Reported award amounts total $10,643,887. Reported amounts are not federal obligations.

Phases: Phase I, Phase II

Agencies: Department of Health and Human Services, Department of Defense, National Science Foundation

Agency intelligence

Department of Health and Human Services

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