First-in-Man Clinical Evaluation of a Novel Tissue Engineered Vascular Graft
Preliminary results of a first-in-man pilot study of a novel bioengineered vascular graft in 28 dialysis patients with end-stage renal disease showed the graft could be used successfully for venous access and was not associated with infections, immune responses or aneurysms in the first six months of the study. The results were presented Nov. 20 as part of AHA 2013.
The open-label, single-arm study was initiated in December 2012, and involved monthly clinical and ultrasound monitoring of the patients for the first six months. Initial data of the investigational bioengineered vessels showed one hundred percent were patent, although eight of the 28 patients required 10 graft patency interventions – eight thrombectomies and two venous anastomosis angioplasties – after losing graft patency in December 2012.
The vascular flow rates in the vessels were >500 ml/min, making them suitable for dialysis. Twenty-two of the patients in the study have used the bioengineered vessel for dialysis three times a week.
Jeffrey H. Lawson, MD, PhD, professor of surgery and of pathology at Duke University School of Medicine, Durham, NC, who presented the study, noted that the grafts were easy to cannulate using standard techniques, and delayed hemostasis requiring intervention occurred only once in more than 800 dialysis access procedures performed in up to nine months. Venous stenosis has occurred in three of the 28 patients.
Further, the novel graft was compared with polytetrafluoroethylene (PTFE) grafts, since current PTFE grafts have less than a 50 percent primary patency rate and less than a 77 percent secondary patency rate when used for dialysis access, with stenosis causing loss of patency in two-thirds of PTFE grafts. In addition, current grafts are associated with a 7 percent to 11 percent risk of infection.
The authors note that the vessel "may one day offer the growing end stage renal disease patient population an alternative option for dialysis access."
The patients will be followed for two years, and additional clinical studies will be required to confirm preliminary and final results of this study. The vessel hasn't been submitted for regulatory approval by the U.S. Food and Drug Administration or any other regulatory authority.
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