News and Features Ushering in a New Era of Regenerative Congenital Cardiac Surgery for Children

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 Mercy.

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 medicine.

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 cardiovascular repairs.

"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 commercialization/biotechnology transfer.

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

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