Abstract 40

PORCINE SMALL INTESTINE SUBMUCOSA IS NOT AN ACELLULAR COLLAGENOUS MATRIX AND CONTAINS PORCINE DNA: POSSIBLE IMPLICATIONS IN HUMAN IMPLANTATION.

Jimin Chen¹ ,Craig Willers¹ , Ming-Hao Zheng ¹

¹ School of Surgery and Pathology (Orthopaedics), University of Western Australia

Porcine small intestinal submucosa (SIS) has been recommended as a cell-free, biocompatible biomaterial for the repair of rotator cuff tendon tear. However, we have observed non-infectious oedema and severe pain in patients who have undergone SIS implantation for tendon repair. The aim of this study was to conduct an independent assessment of the safety and efficacy of Restore^™ SIS membrane. The Restore^™ orthobiologic implant was examined by histology and the Nested PCR technique using porcine immunoreceptor DAP122 gene to examine if SIS membrane contained porcine cells or DNA respectively. The material was also implanted into mice and rabbits for the evaluation of biological reaction and inflammatory response. Restore^™ SIS was found to contain multiple layers of porcine cells. Chloroacetate esterase staining showed that some of these cells were mast cells. Nested PCR of the DAP122 gene demonstrated that Restore^™ SIS contained porcine DNA material. Subcutaneous implantation of Restore^™ SIS membrane in mice, and in rabbits for rotator cuff tendon repair, showed that the membrane caused an inflammatory reaction characterized by massive lymphocyte infiltration. In conclusion, Restore^™ SIS is not an acellular collagenous matrix, and contains porcine DNA. Our results contradict the current view that Restore^™ SIS is a cell-free biomaterial, and that no inflammatory response is elicited by its implantation. We suggest that further studies should be conducted to evaluate the clinical safety and efficacy of SIS implant biomaterials.

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