After more than three years of research using extracellular matrix patches in ovine models, investigators in the Heart Institute have preliminary proof that extracellular matrix can and seems to remodel itself. The discovery has helped lead to the first ever FDA study in humans of a tissue engineered bioprosthetic valve.

David L.S. Morales, MD, Director, Congenital Heart Surgery, is an investigator in the FDA clinical trial of CorMatrix ECM Tricuspid Valve, the flexible, stentless valve that was studied here. Cincinnati Children’s is one of 8 approved sites for the clinical trial and the first to implant a pediatric patient in the trial.

Morales and his team demonstrated the remodeling potential of this valve in an animal model, in the tricuspid position. The valve seemingly grew and formed chordae while remaining functional over the two year study period. 

“The most remarkable thing we found was remodeling,” Morales said. “Because of our research and the fact that people started using the valve clinically in adults, this became the first FDA study of a tissue engineered valve in humans.”

The trial will enroll 15 total patients who are candidates for the surgical management of tricuspid valve disease who are not amenable to valve repair, including tricuspid valve disease secondary to congenital heart disease in pediatric patients.

“This is not a panacea,” Morales said. “I do not know that this ECM will remodel every time, but right now we are investigating why it works, where it works and when it works. This is how we hope to figure out how and where it will work every time.”

CorMatrix ECM Tricuspid Valve at implant (left) and at 18 months post implant in sheep with well-formed papillary attachments and chordae formation (right).