Patient-Specific Nanofiber Tissue Engineered Vascular Grafts Using 3D Printing
PI: Jed Johnson, PhD
AFFILIATION Nanofiber Solutions, Inc
Recent progress in imaging technologies such as ultrasound, CT, and MRI allows surgeons detailed, three- dimensional (3D) views of complex cardiac and vascular anatomy of congenital heart disease before surgery. Such technology also offers significantly more utility with the advent of 3D printing technology. 3D images obtained from patients can be modified into a computer model for printing.
Improved patient care can be obtained by manufacturing these patient-specific TEVGs. Such a technique could drastically enhance the available treatments available for children suffering from congenital heart disease (CHD). By focusing on the pediatric population, we will be able to leverage our current FDA clinical trial  to receive humanitarian use device (HUD) designation and initiate commercial sales using an humanitarian device exemption (HDE) with a significantly shorter regulatory pathway.
Development of a Noninvasive Pediatric Respiration Monitor
PI: Govind Rao, PhD
AFFILIATION: University of Maryland Baltimore County, Center for Advanced Sensor Technology and GE Healthcare, Baltimore, MD
Imaging Through the Eardrum for Improved Diagnosis of Middle Ear Disease
PI: Ryan Shelton, PhD
AFFILIATION: PhotoniCare, Inc
Medical Center for an exploratory study.
A Modular and Adjustable Prosthetic Socket for Pediatric Patients
PI: Ranjit Steiner
AFFILIATION: LIM Innovations, Inc
GMP Production of Human Engineered Tissue Conduits for Pediatric RVOT Reconstruction
PI: Robert Tranquillo, PhD
AFFILIATION: University of Minnesota
sacrificial fibrin gel tube. Laboratory testing shows decellularized engineered tissue tubes with similar physiological strength and compliance can be made from human dermal fibroblasts. These tubes are thus suitable for RVOT reconstruction in pediatric patients for a potential humanitarian device exemption clinical trial. Available grafts for these patients (approx. 1,000 per year) have zero growth capacity, often requiring 5-7 open-heart surgical procedures until adulthood. Our decellularized engineered tissue tubes,
which have the feature of being allografts, could provide a one-time surgery option for these patients because they appear to exhibit growth capacity. GMP production of these tubes is necessary for a clinical trial. This project is to establish GMP production at the University of Minnesota’s Molecular and Cellular Therapeutics facility. Two batches of 3 human decellularized engineered tissue tubes will be produced according to GMP and subjected to GLP testing.