SBIR-STTR Award

The proposed study is designed to develop and evaluate a method of replacing the trachea with a compound prosthesis that will be epithelized at the time of implantation by tissue culture of buccal mucosa or a free graft of tracheal mucosa. Healing of the cervical trachea to two types of prostheses will be evaluated in dogs. Both types will have a rigid polyethylene outer layer and a middle layer of atelocollagen. The inner layer, or Type 1 prosthesis, will consist of buccal mucosal tissue cultured onto the collagen layer. The Type 2 prosthesis will have a free graft of tracheal mucosa. The prostheses will be evaluated at various postimplantation times of up to 60 days. Evaluation of the surgical sites for grafted and cultured mucosal healing, proliferation, connective tissue growth, scarring, infection, and rejection will be performed by gross examination and histopathological methods.National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

The Phase I study demonstrated that a compound tracheal prosthesis consisting of a rigid outer layer and an inner biodegradable layer can successfully replace 7.5 cm of cervical trachea in the dog without infection, rejection, or extrusion. The prothesis permitted intraluminal epithelization by growth and migration and by free operative buccal mucosal grafts. The Phase II study will continue to evaluate a rigid compound tracheal prosthesis as a replacement for 4-6 cm of cervical trachea. A second study will evaluate a rigid compound tracheal patch to widen the tracheal and sub-glottic lumen in lambs raised to maturity. A third study will develop and evaluate a flexible compound tracheal prosthesis to replace up to 10 cm of thoracic trachea. Methods to increase the rate of epithelization of the prosthetic lumen using incorporation of growth factors, extracellular basement membrane matrix on the inner layer, free operative buccal mucosal grafts, and in-vitro preoperative tissue culture grafting will be evaluated.

Thesaurus Terms:
Biomaterials, Biomaterials Evaluation, Oral-Pharyngeal, Mucosa, Prosthesis Implants And Compatibility, Respiratory System Prosthesis, Respiratory System, Epithelium, Respiratory System, Trachea Injuries, Wound Healing, Membrane, Basement Membrane, Tissue Compatibility-Transplant, Isoalloimmunity, Cell Growth Regulation Animals, Chordates, Mammals, Carnivores, Dogs, Tissue (Cell) Culture, Histopathology