Clinically, arterial revascularization is commonly used to treat a number of arterial diseases. Prosthetic grafts are not utilized in coronary or in infrageniculate bypass procedures. In addition, prosthetic graft infections are associated with tremendous morbidity and mortality. Autologous grafts are utilized but there use is limited. Currently, the conduit of choice is the autologous vein. However, many patients do not have suitable veins for these procedures. Human cryopreserved veins are another option; however, vein arterialization may be related to graft failures. Cryopreserved arteries have been used in the past as vascular conduits being more suitable physiologically. However, early grafts underwent significant immune-mediated degradation with subsequent aneurysm formation. This Phase I study will test the performance of uniquely cryopreserved donor artery as an arterial bypass graft in an in vivo system, utilizing modern cryopreservation technology. Using a model system, the utility of cryopreserved artery will be tested in the presence and absence of an immulogical challenge. If successful in determining parameters important in maintaining graft integrity and patency it may be possible, in a subsequent Phase II submission, to test graft modifications which may ultimately lead to a product which could represent a substantial proportion of the universal vascular prosthesis market.
Estimates of the size of the vascular graft market in the USA range between 200,000 and 450,000 per annum. Approximately 15% of patients will not have suitable autologous vessels due to preexisting vascular disease or use in prior vascular procedures. Development of arterial conduit suitable for use as vascular graft would represent a product with significant market potential.
| Giglia, Joseph S; Ollerenshaw, Jeremy D; Dawson, Patti E et al. (2002) Cryopreservation prevents arterial allograft dilation. Ann Vasc Surg 16:762-7 |
