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.

Tissue Engineering for Total Meniscal Substitution: Animal Study in Sheep Model

“…Although this may suggest a lack of an immunological response, it is becoming clear that SIS graft recipients do amount a helper T type 2-restricted immune response. 46 Nevertheless, this is not associated with graft rejection. In the case of SIS, the most likely cause of Results are given as mean AE SD.…”

Scaffolding in tissue engineering: general approaches and tissue-specific considerations

“…Decellularized ECM can also be used for non-homologous functions when it is used for a purpose different from which it fulfills in its native state, or in a location of the body where such structural function does not normally occur. Examples are to use small intestinal submucosa (SIS) for vascular graft, tendon, dura mater, skin and other tissues [7,8,38,49,101] and to use amnion membrane for peripheral nerve regeneration [77]. The major advantage of this scaffolding approach is the most close-to-nature mechanical and biological properties of the decellularized ECM.…”

Experiência inicial no tratamento endoscópico de fístulas gastrocutâneas pós-gastroplastia vertical redutora através da aplicação de matriz acelular fibrogênica

“…Em todos, foram detectados anticorpos específicos cujos títulos foram diminuindo a partir dos 6 meses da operação. Em nenhum deles, houve sinais imunológicos ou clínicos de rejeição do implante (2) .…”