FRIDAY, April 24 (HealthDay News) -- Autologous tissue-engineered vascular grafts can help end-stage renal disease patients gain a better outcome from hemodialysis, according to a study published in the April 25 issue of The Lancet.
Todd N. McAllister, Ph.D., of Cytograft Tissue Engineering in Novato, Calif., and colleagues conducted a study of 10 patients in Argentina and Poland with end-stage renal disease, all of whom had been receiving hemodialysis via an access graft with a high probability of failure and at least one previous access failure. The patients received arteriovenous shunts comprising autologous tissue-engineered vascular grafts that had been grown in culture supplemented with bovine serum.
During the first three months, the grafts were assessed for mechanical stability, and subsequently for effectiveness after commencement of hemodialysis. In the safety phase, three grafts failed, one patient withdrew due to severe gastrointestinal bleeding before implantation, and a fifth died of unrelated causes, the investigators noted. The five remaining patients had functioning grafts six to 20 months after implantation and one required surgery to maintain secondary patency of the graft.
"Clearly with only 68 patient-months of graft patency, statistically meaningful comparisons with the standard of care would be premature, but results are encouraging," the authors write. "Even in view of the challenges associated with this patient population and our conservative protocol, this patency rate seems reasonable for this early clinical study."
The study was funded by Cytograft Tissue Engineering.
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