The Hartwell Foundation Provides Grant to University of Michigan Researchers

Supports investigation into "knifeless" surgery for pediatric heart defect

ANN ARBOR, Mich., March 11, 2013 /PRNewswire-USNewswire/ -- The Hartwell Foundation, of Memphis, TN, awarded three University of Michigan researchers with a three-year, $884,165 grant for their investigation into "knifeless" surgery for the treatment of the pediatric heart defect, hypoplastic left heart syndrome (HLHS).

"Support for clinical translation of this exciting innovation was possible because matching funds were available from other sources and sufficient infrastructure exists within The University of Michigan to sustain an eventual clinical trial," said Fred Dombrose, President of the Hartwell Foundation.

The University is a Hartwell Foundation Top Ten Center of Biomedical Research.

Charles Cain, Ph.D., Richard A Auhll Professor of Engineering and 2007 Hartwell Investigator; Gabe Owens, M.D., Ph.D., assistant professor of pediatric cardiology; and Zhen Xu, Ph.D., assistant professor of biomedical engineering, are the recipients of the grant and will work to gather pre-clinical data in preparation for a human clinical trial on infants with HLHS.

"The Department of Pediatrics and C.S. Mott Hospital are excited about the promise of this technology to improve the lives of children with congenital heart disease and other life threatening disorders," said Valerie Castle, Ravitz Foundation Professor of Pediatrics and Communicable Diseases and chair of the Department of Pediatrics and Communicable Diseases with the U-M Medical School. "Our partnership with The Hartwell Foundation represents the best of what we do at Michigan – bringing teams of interdisciplinary scientists from disciplines in Medicine and Engineering together to develop the treatments and technologies of tomorrow."

In patients with HLHS, normal flow is obstructed in the fetal heart resulting in a poorly functioning and underdeveloped left ventricle, or pumping chamber. In addition, the valves on the left side of the heart also function poorly and the main artery leaving the heart is smaller than normal.

HLHS is the most common severe congenital heart malformation with about 1,000 new cases each year in the U.S.; the cause is unknown.

"This funding from The Hartwell Foundation will help University of Michigan researchers move from laboratory invention to clinical trials with a technology that may well transform how we approach surgery for the youngest of patients," said U-M President Mary Sue Coleman.

Cain, Owens and Xu sought to find an alternative approach to the risky, invasive three-stage surgical reconstruction and reconfiguration that can take up to two years to correct, but reduces the chance of a vibrant life, with mortality at 35-40%.

Cain's innovative ultrasound technique is a non-invasive alternative to using a scalpel.  In effect, acoustically formed bubbles generated by ultrasound are aimed deep within the body as "mini-scalpels" to precisely fragment and erode tissue –– without bleeding, stitches or the risk of infection. Cain's work to apply this technology on fetal heart defect was funded initially by The Hartwell Foundation, as a 2007 Individual Biomedical Research Award recipient. 

Cain and his collaborators envision that the application of histotripsy for HLHS will work by creating flow channels within the tissue of the fetal heart to correct abnormal blood flow.

Hypothetically, creating a channel between the ventricles while the fetus is still developing inside the uterus would allow the heart to develop normally, so that HLHS never fully occurs. The researchers are now seeking to demonstrate the safety of a specially designed pediatric histotripsy system in order to acquire regulatory approval from the FDA for a human clinical trial on infants born with HLHS.

If successful in newborns, they plan to use their innovative technology for treating the HLHS condition in the developing fetus, in utero.

The Hartwell Foundation has named Michigan one of its Top Ten Centers of Biomedical Research each of the last seven years, during which time Michigan faculty have received six Hartwell Individual Biomedical Research Awards. The Hartwell Foundation has provided financial support for one post-doctoral fellowship each year, as well.

The Hartwell Foundation seeks to inspire innovation and achievement by supporting innovative and cutting-edge biomedical applied research that will potentially benefit children of the United States. The Foundation provides financial support for early stage research projects that have not yet qualified for funding from traditional sources.

For more information visit www.thehartwellfoundation.org

Contact: Judith Malcolm – [email protected], +1-734-647-7583 

SOURCE University of Michigan