Presentation Abstract

Session: CS.04-Advanced Cardiovascular Disease: Complications and Challenges
Presentation: First-in-Man Clinical Evaluation of a Novel Tissue Engineered Vascular Graft
Pres Time: Wednesday, Nov 20, 2013, 11:07 AM -11:17 AM
Location: Ballrooms C1&C2
Pres. Time: Wednesday, Nov 20, 2013, 11:07 AM -11:17 AM
Keywords: Vascular surgery; Tissue engineering; Extracellular matrix; Clinical trials
Presenter: Jeffrey H Lawson, Duke Univ, Durham, NC
Abstract: Introduction:
End stage renal disease patients who require hemodialysis access would benefit from an alternative to synthetic grafts, which have high rates of thrombosis and intimal hyperplasia. A graft with success rates that are similar to those of fistulas would be clinically advantageous. Our tissue-engineered vascular graft is comprised of human extracellular matrix and is similar in strength to native human vein and artery. This acellular graft may be stored in a regular refrigerator, making it readily available for off-the-shelf surgical use. This graft is currently in clinical studies for evaluation of safety and efficacy in hemodialysis vascular access in patients with end stage renal disease.
Methods:
Banked human aortic smooth muscle cells were cultured in bioreactors in vitro to produce vascular tissue grafts, and a decellularization process was subsequently employed to remove cellular antigens and render grafts non-immunogenic. Arteriovenous grafts were implanted into non-human primates for up to 6 months, and were evaluated for patency, durability, cannulation, rejection, and cellular repopulation. Directional guidance for the definitive primate study was provided by implantation of canine-derived grafts into canines.
Results:
Graft mechanical integrity was retained throughout 1-year of refrigeration in these acellular grafts. In all studies, implanted grafts were safe, well tolerated, and functioned as intended. No significant intimal hyperplasia was observed in any graft. Histologic analysis demonstrated evidence of host vascular cell migration into the graft. Canine studies demonstrated safety and function of engineered tissues in long-term (1-year) studies. These preclinical studies supported initiation of clinical trials.
Conclusions:
These novel non-immunogenic grafts demonstrated excellent patency, tolerance of cannulation, absence of infection, absence of significant intimal hyperplasia, and low rates of intervention. Based on these successful pre-clinical studies, a Phase I clinical study of the safety and efficacy of Humacyte’s human acellular vascular grafts in patients with end stage renal disease is currently underway.
Disclosures:   J.H. Lawson: Research Grant; Modest; Department of Defense via Humacyte. Consultant/Advisory Board; Significant; Humacyte, Inc.. M. Iłżecki: None. T. Jakimowicz: None. A.J. Pilgrim: Employment; Significant; Humacyte, Inc.: Chief Medical Officer. S. Przywara: None. J. Szmidt: None. J. Turek: None. W. Witkiewicz: None. N. Zapotoczny: None. T. Zubilewicz: None. L.E. Niklason: Ownership Interest; Significant; Humacyte, Inc..



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