Each year, a reported 4,000 children in the United States need
semilunar - aortic and pulmonary - valve replacements.
Thus, the need to identify a more efficient, cost-effective
solution for heart valve replacement in children continues to be at
the forefront for cardiovascular surgery researchers at Children's
Mercy Hospitals and Clinics in Kansas City, Mo.
"Our central goal is to create a viable personal heart valve
suitable for surgical implantation, tissue engineered in a
clinically realistic time frame using allogeneic valve scaffolds
seeded with patient derived cells that must be capable of growth
and adaptation following replacement of congenitally malformed or
absent valves," says Richard A. Hopkins, MD, the Thomas Holder/
Keith Ashcraft Endowed Chair in Pediatric Surgery Research,
Director of the Cardiac Regenerative Surgery Research Laboratories
at Children's Mercy and a Professor of Surgery at University of
Missouri-Kansas City School of Medicine.
"Our success will fundamentally impact surgical therapeutics and
essentially initiate a new era of regenerative congenital cardiac
surgery for children," adds Dr. Hopkins.
Once fully developed and approved, a living, growth-capable
valve will eliminate the need for multiple reoperations as is
currently required for available valve prosthetics.
"As we move toward the development of the clinical version of
the tissue engineered heart valve, we will continue to seek
regulatory guidance from the FDA based on the data generated from
our preclinical safety and performance studies," adds Stephen
Hilbert, MD, PhD, Deputy Director of the Cardiac Regenerative
Surgery Research Laboratories.
The groundbreaking project is just one of several of its kind in
development at the Cardiac Regenerative Surgery Research
Laboratories (CRSRL) of The Ward Family Heart Center at Children's
The CRSRL is dedicated to the translation of fundamental
scientific research into therapeutic strategies for the treatment
of congenital and structural cardiac disorders.
Striving to improve the care of patients with congenital cardiac
disease through innovative translational research, the CRSRL
fosters focused research and the development of collaborations by
leveraging expertise in the fields of cardiac surgery, cardiology,
cardiac anesthesiology, cardiac imaging, bioengineering, tissue
engineering, cell biology, developmental biology, molecular
biology, cardiovascular pathology, biotechnology and regenerative
The team - which works out of the academic and discovery
laboratory at Children's Mercy and through multiple collaborations
with university partners in the Kansas City area as well as with a
full-time Good Laboratory Practices (GLP) compliant testing
facility located in Maryland - also is working on projects that
include a range of cell, tissue, polymer, drug eluting and gene
engineered constructs for surgical and catheter based
"Combining excellence in clinical surgery with translational
research and development generates unique research projects and
collaborations," says Dr. Hopkins. "As evidenced by our published
work during the past two years, we are adding to the body of
knowledge regarding tissue engineering that goes well beyond heart
valves. Our work in the CRSRL is leading to multicenter cutting
edge clinical trials, and a leadership role in defining regulatory
criteria that, ultimately, gives us the potential to vastly improve
the lives of children."
To perform each of these projects at the highest level,
capabilities have been established for academic research, product
research and development, preclinical experimental studies,
applications testing, FDA regulatory research leading to market
approval for devices, drugs, and biologics, and
This deliberately translational laboratory design allows
projects to evolve from concept, through discovery and applied
research phases, preregulatory and preclinical experimental
modeling, ultimately resulting in Phase I clinical trials, all
within one institution.
"Children's Mercy has made a commitment to regenerative
surgery," adds Dr. Hopkins. "This approach is a major component of
what we believe to be the future of pediatric cardiac surgery in
the 21st century."
Richard Hopkins, MD