Approximately 42% of infants’ mortality in the world is related to congenital heart defects (prevalence: 8-12/1000 births). Over 1/3 require the reconstruction of the right ventricular outflow tract (RVOT) by surgical procedures which currently use inert materials without any growth potential. Consequently, multiple reoperations are often required, with their attendant high risk of mortality and morbidity.
The TEH-TUBE project will address these limitations by creating a novel bioabsorbable biomaterial using a polymeric valved tube either seeded with autologous mesenchymal stem cells (MSC) or functionalized by a peptidic sequence triggering homing of the host cells onto the scaffold to make it a living self-populated structure.
During the project we will:
Compare 3 different polymers processed by electrospinning to generate a 3-D bioabsorbable valved tube with an advanced design;
Compare, in the selected polymer, MSC seeding and peptide grafting using in vitro mechanical and biological tests as well as in vivo animal experiments (primarily rats) ;
Validate the mechanical properties, regenerative potential, biocompatibility and growth potential of the ultimate combination (polymer + cells or peptides) in a clinically relevant large animal model (growing lamb).
This stepwise approach will be conducted within a tightly controlled regulatory framework to ensure that the final product meets the current ATMP requirements for phase I/II clinical studies and, if successful, ultimate commercialization.
Our TEH-TUBE project aims at developing an innovative biomaterial for the treatment of congenital heart abnormalities in children and young adults. By creating a material whose growth will keep pace with that of the patient, this product, geared to become an ATMP, should decrease the risk of reoperative surgeries, improve the quality of life and ultimately have a positive impact on healthcare costs.