You are here

Artificial Placenta Device

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44HD078001-02
Agency Tracking Number: R44HD078001
Amount: $1,264,354.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NICHD
Solicitation Number: PA12-088
Timeline
Solicitation Year: 2013
Award Year: 2015
Award Start Date (Proposal Award Date): 2014-12-12
Award End Date (Contract End Date): 2017-11-30
Small Business Information
2555 BISHOP CIR W
Dexter, MI 48130-1563
United States
DUNS: 806687406
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 KATHRYN OSTERHOLZER
 (734) 995-9089
 koster@mc3corp.com
Business Contact
 SCOTT MERZ
Phone: (734) 995-9089
Email: merz@mc3corp.com
Research Institution
N/A
Abstract

DESCRIPTION provided by applicant There are million births in the United States each year of which are premature Prematurity is associated with substantial mortality morbidity and escalating cost The complications of premature birth include respiratory gastrointestinal and central nervous system morbidity and significant mortality Many of these complications are caused directly or indirectly by our attempts to ventilate the immature lungs and reverse fetal circulation Although many of these babies recover with conventional management the mortality and morbidity of extremely low gestational age newborns ELGANs defined as born more than months before the expected date of birth is very high The current approach of positive pressure gas ventilation carries high risks of mechanical trauma and oxygen toxicity to the lungs A major paradigm shift in the post natal treatment of prematurity would be to avoid the complications of positive pressure ventilation and recreate the fetal environment with an Artificial Placenta AP which consists of four unique features maintaining fetal circulation and environment no mechanical ventilation simulated fetal breathing with fluid filled lungs and a novel form of a pump driven veno venous extracorporeal life support VV ECLS circuit with inflow via the umbilical vein and outflow via the right internal jugular vein Our collaborators at the University of Michigan Extracorporeal Life Support Lab ECLS Lab have demonstrated feasibility and reproducibility of complete extracorporeal support with medical components to simulate an artificial placenta for up to days with hemodynamic stability excellent gas exchange stable cerebral perfusion and maintenance of fetal circulation without mechanical ventilation The goal of this research project is to design and produce an integrated system that will function as an Artificial Placenta for the post natal treatment of very premature infants andlt weeks gestational age Our system will support ELGANs in the most natural state i e fetal circulation and is truly innovative and offers many therapeutic opportunities when compared to current clinical practice with mechanical ventilation Phase l aims include integration of the MC BioLung and MPump devices with cartridge heat modules and an automated sweep gas controller The system will be coated with our unique nonthrombogenic NO secreting polymer to decrease or eliminate the need for systemic anticoagulation The prototype system will be fabricated and tested in vitro to demonstrate safety efficacy and durability A pilot in vivo study will be conducted to demonstrate effective fetal circulation Phase ll will include extended in vivo testing of AP for safety and efficacy and the development of a clinical ready device The University of Michigan Extracorporeal Life Support Lab and MC are the leaders in this field and can bring this technology to reality in four years This project has high translational potential and would impact
substantially upon the care of high risk premature newborns Successful completion of this research will lead to a clinical trial in moribund premature infants PUBLIC HEALTH RELEVANCE The goal of this research project is to design produce and test an integrated system that will comprise an Artificial Placenta AP for the post natal treatment of very premature infants andlt weeks gestational age This proposal has high translational potential and would impact substantially upon the care of high risk premature newborns

* Information listed above is at the time of submission. *

US Flag An Official Website of the United States Government