Immune response to small intestinal submucosa (surgisis) implant in humans: preliminary observations.

Abstract

Surgisis IHM is an acellular biomaterial derived from porcine small intestinal submucosa (SIS) that induces site-specific remodeling in the organ or tissue into which it is placed. Previous animal studies have shown that the graft recipient mounts a helper T type 2-restricted immune response to the SIS xenograft without signs of rejection. The aims of this study were to evaluate the immune response to the SIS implant in a small series of humans and to examine the long-term clinical acceptance of the xenograft in these patients. Five consecutive male patients (mean age 56 years, range 34-68) who underwent inguinal hernioplasty with Surgisis IHM were assessed at 2 weeks, 6 weeks, and 6 months after implant for SIS-specific, alpha-1,3-galactose (alpha-gal) epitope and type I collagen specific antibodies. All five patients were also clinically assessed up to 2 years for signs of clinical rejection, hernia recurrence, and other complications. All 5 patients implanted with Surgisis IHM produced antibodies specific for SIS and alpha -gal with a peak between 2 and 6 weeks after implantation. By 6 months, all patients showed decreasing levels of anti-SIS antibodies. Two patients developed a transient, mild local seroma that resolved spontaneously. None of the patients showed any clinical signs of rejection, wound infection, hernia recurrence, or other complications in the follow-up out to 2 years. Thus, this study showed that in a small series of patients the SIS elicits an antibody response without clinical rejection of the xenograft and minimal postoperative complications.

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@article{Ansaloni2007ImmuneRT, title={Immune response to small intestinal submucosa (surgisis) implant in humans: preliminary observations.}, author={Luca Ansaloni and Paolo Cambrini and Fausto Catena and Salomone Di Saverio and Stefano Gagliardi and Filippo Gazzotti and Jason P. Hodde and Dennis W. Metzger and Luigi D'Alessandro and Antonio Daniele Pinna}, journal={Journal of investigative surgery : the official journal of the Academy of Surgical Research}, year={2007}, volume={20 4}, pages={237-41} }