Non-Immunogenic Structurally and Biologically Intact Tissue Matrix Grafts for the Immediate Repair of Ballistic-Induced Vascular and Nerve Tissue Injury in Combat Casualty Care
Abstract
In the first year of this graft processes were developed that provided a decellularized, cryopreserved, and freeze-dried human umbilical artery and vein for use as off-the-shelf vascular grafts. Short term animal studies indicated that the vein graft had potential as a hemodialysis graft. However, close evaluation of those tissues indicated that there were defects that may have clinical impact. This past year the source of he defects was determined to be the freeze-drying process. Ongoing efforts toward process optimization and design modifications that will provide undamaged tissue grafts are presented in this report. Essential processing modifications, procurement systems and a total quality plan were also developed and implemented. Biocompatibility testing was performed and when it was appropriate biomechanical verification testing was completed. In addition, the umbilical artery was evaluated for the first time in large animals. Graft related adverse events led to further tissue processing optimization. That work is presented in this report but artery process development is still ongoing.
Document Details
- Document Type
- Technical Report
- Publication Date
- Dec 01, 2003
- Accession Number
- ADA420129
Entities
People
- Nathaniel Bachrach