Immune response to small intestinal submucosa (Surgisis) implant in humans: Preliminary observations
Immune response to small intestinal submucosa (Surgisis) implant in humans: Preliminary observations
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DOI：
10.1080/08941930701481296
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发表时间：
2007-01-01
影响因子：
1.9
通讯作者：
Pinna, Antonio Daniele
中科院分区：
文献类型：
--
作者：
Ansaloni, Luca;Cambrini, Paolo;Pinna, Antonio Daniele
Surgisis IHM是一种从猪小肠黏膜下层(SIS)中提取的无细胞生物材料，可诱导其所在器官或组织的部位特异性重塑。先前的动物研究表明，移植物受体对SIS异种移植物产生辅助T-2型限制性免疫反应，没有排斥迹象。这项研究的目的是评估一小部分人对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性。连续5例接受外科腹股沟疝修补术的男性患者(平均年龄56岁，范围34~68岁)分别在植入后2周、6周和6个月检测SIS特异性、α-1，3-半乳糖(α-GAL)表位和I型胶原特异性抗体。所有5名患者都进行了长达2年的临床评估，以了解临床排斥反应、腹股沟复发和其他并发症的迹象。所有5例植入Surgisis IHM的患者都产生了针对SIS和α-GAL的抗体，高峰出现在植入后2-6周。6个月后，所有患者的抗SIS抗体水平均下降。两名患者出现一过性、轻微的局部血清肿块，并自行消退。随访2年，无1例患者出现排斥反应、伤口感染、腹股沟复发或其他并发症。因此，这项研究表明，在一小部分患者中，SIS在没有异种移植物临床排斥反应和最小的术后并发症的情况下产生了抗体反应。
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 a-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.