Ansaloni Luca, Cambrini Paolo, Catena Fausto, Di Saverio Salomone, Gagliardi Stefano, Gazzotti Filippo, Hodde Jason P, Metzger Dennis W, D'Alessandro Luigi, Pinna Antonio Daniele
Unit of General Surgery, University of Bologna, Sant'Orsola-Malpighi Hospital, Bologna, Italy.
J Invest Surg. 2007 Jul-Aug;20(4):237-41. doi: 10.1080/08941930701481296.
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.
Surgisis IHM是一种源自猪小肠黏膜下层（SIS）的无细胞生物材料，可在其植入的器官或组织中诱导位点特异性重塑。先前的动物研究表明，移植物接受者对SIS异种移植物产生辅助性T2型受限免疫反应，且无排斥迹象。本研究的目的是评估一小部分人类对SIS植入物的免疫反应，并检查这些患者对异种移植物的长期临床接受情况。对连续5例接受Surgisis IHM腹股沟疝修补术的男性患者（平均年龄56岁，范围34 - 68岁）在植入后2周、6周和6个月时进行评估，检测其针对SIS特异性、α-1,3-半乳糖（α-gal）表位和I型胶原的特异性抗体。所有5例患者还进行了长达2年的临床评估，以检查临床排斥、疝复发和其他并发症的迹象。所有5例植入Surgisis IHM的患者均产生了针对SIS和α-gal的特异性抗体，在植入后2至6周达到峰值。到6个月时，所有患者的抗SIS抗体水平均下降。2例患者出现短暂、轻度的局部血清肿，随后自行消退。在长达2年的随访中，没有患者出现任何排斥、伤口感染、疝复发或其他并发症的临床迹象。因此，本研究表明，在一小部分患者中，SIS引发了抗体反应，但异种移植物未出现临床排斥，术后并发症也很少。
