Patient-Specific Nanofiber Tissue Engineered Vascular Grafts Using 3D Printing

PI: Jed Johnson, PhD
AFFILIATION Nanofiber Solutions, Inc
Award: $50,000

In this project “Patient-Specific Nanofiber Tissue Engineered Vascular Grafts Using 3D Printing” we propose a new paradigm in vascular graft research and patient treatment with the development of a patient- specific tissue engineered vascular graft (TEVG). This unique interdisciplinary collaborative project combines the clinically proven expertise of synthetic nanofiber scaffolds from Dr. Jed Johnson at Nanofiber Solutions, Inc. (Columbus, OH), the tissue engineering and surgical experience of Dr. Narutoshi Hibino in the Cardiothoracic Surgery Department at Nationwide Children’s Hospital (Columbus, OH), and the advanced 3D printing technology using computer-aided design software from Dr. Axel Krieger at Children’s National Medical Center (Washington, DC). Through this innovative collaboration, we hypothesize that tailor-made nanofiber TEVGs created by utilizing pre-operative 3D imaging data combined with a computer aided design (CAD) model, 3D printing and nanofiber technology will result in dramatically improved patient care. The mandrel for the patient-specific nanofiber scaffolds will be printed from the pre-surgery 3D imaging data combined with a CAD model. The nanofiber scaffold implant will then be coated around this custom mandrel for the creation of a patient-specific TEVG

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 [3] 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
Award: $50,000

We seek funds to develop a novel non-invasive respiration monitor. This device is based on the diffusion of oxygen and carbon dioxide across the skin and is simple and painless to use. Preliminary tests in the NICU indicate good correlation with arterial blood gas measurements.

Imaging Through the Eardrum for Improved Diagnosis of Middle Ear Disease

PI: Ryan Shelton, PhD
AFFILIATION: PhotoniCare, Inc
Award: $50,000

Otolaryngologists and primary care physicians are responsible for diagnosing and treating the general population for ear disease, but they have limited tools with which to accomplish this. The current standard diagnostic tool for evaluating the middle ear, the otoscope, is a basic magnifier of tissue surfaces and has limited diagnostic ability and repeatability. The longterm goal of this work is to reduce healthcare costs and improve patient outcomes by giving physicians new imaging tools that, for the first time, allow them to see behind the eardrum in order to visualize an infection and take quantitative measurements of middle ear effusions and biofilms. Biofilms have been linked in literature to chronic ear infections that result in tube surgery. To date, the proposed technology is the only way by which biofilms in the middle ear can be identified and visualized non-invasively. This unprecedented view into the middle ear has the potential to fundamentally change the way middle ear disease is managed by providing quantitative indications for surgery and other advanced therapeutics. This project will focus on development of a commercial prototype and deployment of that prototype into Children’s National
Medical Center for an exploratory study.

A Modular and Adjustable Prosthetic Socket for Pediatric Patients

PI: Ranjit Steiner
AFFILIATION: LIM Innovations, Inc
Award: $50,000

Founded two years ago, LIM Innovations has brought a paradigm breaking adult above-knee prosthetic socket to the market. This product is new in terms of structure, use of thermoplastic- fiber composite materials, custom-fit, and adjustability. It delivers a highly individualized fit via a mass customization approach, with accompanying economies of scale. We now intend to leverage lessons learned in design, engineering, and patient needs toward the fast-track development of a pediatric socket. The socket portion of a prosthetic device is the most critical determinant of the clinical success of the device as a whole. Pediatric patients have been just as poorly served by inadequate prosthetic sockets as have their adult counterparts. We have given considerable thought toward development of a pediatric device. In addition to aspects of engineering and design that are directly transferable, we foresee particular areas of new development that are needed, as for example with regard to enhanced adjustability in order to accommodate growth.

GMP Production of Human Engineered Tissue Conduits for Pediatric RVOT Reconstruction

PI: Robert Tranquillo, PhD
AFFILIATION: University of Minnesota
Award: $50,000

Ongoing studies indicate the growth capacity of decellularized engineered tissue tubes made by entrapping sheep dermal fibroblasts in a
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.