Researchers are developing enhanced small intestinal submucosa (SIS) heart valves to treat infants with critical congenital valve disease
There is currently a lack of prosthetic valves in small sizes for infants born with critical congenital valve diseases (CCVD). However, small intestinal submucosa (SIS) has been used for compassionate care treatment of infants with CCVD2 and there is an ongoing clinical trial using SIS for tri-cuspid valve repair in adults.3 The team, led by Dr. Ramaswamy at Florida International University, had three goals for this project, with the ultimate goal of having a bioscaffold device ready for clinical trials for the treatment of CCVD in infants within the next five years. The first goal: to grow human bone marrow-derived mesenchymal stem cells (BMMSC) on cylindrical SIS under dynamic conditions to create a bioscaffold. This was accomplished, and the group demonstrated that the cells deposited human extracellular matrix (ECM) components, including elastin. The second goal: to remove the BMMSC from the scaffolds, leaving human ECM proteins behind. This was also accomplished. The third goal: to grow heart valve cells on the bioscaffolds. These experiments showed that the cells secreted more collagen on the bioscaffolds compared to untreated SIS, suggesting that the bioscaffold will regenerate in the body. Having met these goals, the team will next determine if the bioscaffold can withstand systemic pressures before moving into pre-clinical models.
1 Gonzalez BA, Herrera A, Ponce C, et al. Stem cell-secreted allogeneic elastin-rich matrix with subsequent decellularization for the treatment of critical valve diseases in the young. Bioengineering. 2022;9(10):587.
2 Bibevski S, Scholl FG. Feasibility and early effectiveness of a custom, hand-made systemic atrioventricular valve using porcine extracellular matrix (CorMatrix) in a 4-month-old infant. Ann Thorac Surg. 2015;99(2):710-712.
3 Rescigno G, Hothi S, Bond C, Uddin M, Bhatti V, Billing JS. CorMatrix anterior leaflet augmentation of the tricuspid valve: midterm results. Heart Surg Forum. 2021;24(2):E261-E266. .