title: 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.
authors: Unit of General Surgery, University of Bologna, Sant'Orsola-Malpighi Hospital, Bologna, Italy. lansaloni@aosp.bo.it
authors: Luca
authors: L
authors: Ansaloni
authors: Paolo
authors: P
authors: Cambrini
authors: Fausto
authors: F
authors: Catena
authors: Salomone
authors: S
authors: Di Saverio
authors: Stefano
authors: S
authors: Gagliardi
authors: Filippo
authors: F
authors: Gazzotti
authors: Jason P
authors: JP
authors: Hodde
authors: Dennis W
authors: DW
authors: Metzger
authors: Luigi
authors: L
authors: D'Alessandro
authors: Antonio Daniele
authors: AD
authors: Pinna
mesh_terms: D000328:Adult; D000368:Aged; D000818:Animals; D000906:Antibodies / Q000276:immunology / Q000378:metabolism*; D000917:Antibody Formation / Q000276:immunology*; D001672:Biocompatible Materials / Q000009:adverse effects*; D003094:Collagen / Q000276:immunology; D005690:Galactose / Q000276:immunology; D006552:Hernia, Inguinal / Q000601:surgery*; D006801:Humans; D020007:Implants, Experimental / Q000009:adverse effects*; D007413:Intestinal Mucosa / Q000276:immunology* / Q000601:surgery; D008297:Male; D008875:Middle Aged; D013552:Swine; D023001:Transplantation Tolerance / Q000276:immunology; D014183:Transplantation, Heterologous / Q000276:immunology
chemical_list: D000906:Antibodies; D001672:Biocompatible Materials; D003094:Collagen; D005690:Galactose