A New Biomaterial Derived From Small Intestine Submucosa
A New Biomaterial Derived From Small Intestine Submucosa
A biomaterial derived from porcine intestinal submucosa has been used in the development of a new biologic wound matrix. This review describes the origin of the wound matrix device, including the discovery of the biomaterial and its properties, to the development of the commercial product currently in clinical use. The composition and structure of this biomaterial are described and considered as mechanisms that contribute to its effectiveness in wound management. The wound matrix developed from this unique biomaterial was evaluated in a pilot study of human partial-thickness dermal wounds and was found to be beneficial, especially in its dehydrated form. Other applications of this biomaterial, as well as its limitations, are also discussed.
Biomaterials have become critical components in the development of effective new medical therapies for wound care. As limitations of previous generations of biologically derived materials are overcome, many new and impressive applications for biomaterials are being examined. A new biomaterial was first discovered in 1987 at Purdue University (West Lafayette, Indiana) when researchers were evaluating various biological materials as blood conduits. This biomaterial was derived from small intestine submucosa (SIS). The SIS biomaterial has since been developed into several medical products currently used by healthcare providers in the clinical setting.
Initial investigations leading to the evaluation of SIS as an implantable biomaterial began with the use of sections of whole small intestine. However, the sections of small intestine tissue proved to be too active enzymatically to retain sutures. Subsequent implantation studies used intestine with various layers removed. In the end, the most successful graft was composed solely of the thin, translucent, but resilient, submucosal layer that remained after removing the mucosal and muscular layers. The submucosal layer of the small intestine is approximately 0.15 to 0.25mm thick and consists primarily of a collagen-based extracellular matrix (ECM) containing relatively few resident connective tissue cells. This layer provides structural support, stability, and biochemical signals to the rapidly regenerating mucosal cell layer. The naturally cross-linked collagen network of the submucosal layer also gives strength to the whole intestine. For these reasons, SIS biomaterial was derived from this intestinal layer and used initially for vascular graft studies. Currently, SIS biomaterial is harvested from a porcine source and minimally processed to lyse all resident cells and remove cellular debris as described elsewhere. SIS biomaterial is sterilized using a proprietary method that includes treatment with ethylene oxide. This sequential processing method allows long-term storage of the acellular sheet of ECM without destroying its ability to support wound healing and tissue repair.
Following the initial discovery and evaluation, this naturally occurring ECM-based biomaterial was tested in a number of pre-clinical studies to evaluate its biocompatibility and persistence upon implantation. The SIS biomaterial is biocompatible in all host species tested. In addition, the biomaterial was remodeled gradually into new tissue by the host. This phenomenon was particularly remarkable because the new tissue generated by the host was specific to the site of implantation rather than a generalized fibrotic tissue. For example, when SIS was implanted in place of a blood vessel, within four months the biomaterial had been incorporated and replaced by new tissue, which appeared nearly identical to the original vessel. Even though the conduit had been formed from a single layer of the thin SIS biomaterial, a multilayered vessel was formed, which was several times thicker than the original SIS. The implanted graft supported the development of new artery tissue with an intimal lining of endothelial cells and a supporting outer layer of muscle tissue. This regeneration of tissue structures following implantation has been termed "smart remodeling" by researchers. A biomaterial with such properties was anticipated to provide a suitable covering for dermal wounds, and a pre-clinical animal study has specifically demonstrated the potential effectiveness of SIS as a biological-derived dressing in the clinical setting.
In this review, we report the results of a pilot study showing the initial clinical experiences with the wound matrix device (WMD) developed from the SIS biomaterial. A discussion of the need for and advantages associated with biological-derived dressings as compared to synthetic dressings is followed by a brief review of the discovery and development of the SIS biomaterial. The significant properties revealed in pre-clinical studies and the mechanisms behind the effective tissue restorative properties of the biomaterial are detailed. Finally, the initial clinical experiences with the WMD designed for dermal application and the development of other healthcare products from the SIS biomaterial are discussed.
A biomaterial derived from porcine intestinal submucosa has been used in the development of a new biologic wound matrix. This review describes the origin of the wound matrix device, including the discovery of the biomaterial and its properties, to the development of the commercial product currently in clinical use. The composition and structure of this biomaterial are described and considered as mechanisms that contribute to its effectiveness in wound management. The wound matrix developed from this unique biomaterial was evaluated in a pilot study of human partial-thickness dermal wounds and was found to be beneficial, especially in its dehydrated form. Other applications of this biomaterial, as well as its limitations, are also discussed.
Biomaterials have become critical components in the development of effective new medical therapies for wound care. As limitations of previous generations of biologically derived materials are overcome, many new and impressive applications for biomaterials are being examined. A new biomaterial was first discovered in 1987 at Purdue University (West Lafayette, Indiana) when researchers were evaluating various biological materials as blood conduits. This biomaterial was derived from small intestine submucosa (SIS). The SIS biomaterial has since been developed into several medical products currently used by healthcare providers in the clinical setting.
Initial investigations leading to the evaluation of SIS as an implantable biomaterial began with the use of sections of whole small intestine. However, the sections of small intestine tissue proved to be too active enzymatically to retain sutures. Subsequent implantation studies used intestine with various layers removed. In the end, the most successful graft was composed solely of the thin, translucent, but resilient, submucosal layer that remained after removing the mucosal and muscular layers. The submucosal layer of the small intestine is approximately 0.15 to 0.25mm thick and consists primarily of a collagen-based extracellular matrix (ECM) containing relatively few resident connective tissue cells. This layer provides structural support, stability, and biochemical signals to the rapidly regenerating mucosal cell layer. The naturally cross-linked collagen network of the submucosal layer also gives strength to the whole intestine. For these reasons, SIS biomaterial was derived from this intestinal layer and used initially for vascular graft studies. Currently, SIS biomaterial is harvested from a porcine source and minimally processed to lyse all resident cells and remove cellular debris as described elsewhere. SIS biomaterial is sterilized using a proprietary method that includes treatment with ethylene oxide. This sequential processing method allows long-term storage of the acellular sheet of ECM without destroying its ability to support wound healing and tissue repair.
Following the initial discovery and evaluation, this naturally occurring ECM-based biomaterial was tested in a number of pre-clinical studies to evaluate its biocompatibility and persistence upon implantation. The SIS biomaterial is biocompatible in all host species tested. In addition, the biomaterial was remodeled gradually into new tissue by the host. This phenomenon was particularly remarkable because the new tissue generated by the host was specific to the site of implantation rather than a generalized fibrotic tissue. For example, when SIS was implanted in place of a blood vessel, within four months the biomaterial had been incorporated and replaced by new tissue, which appeared nearly identical to the original vessel. Even though the conduit had been formed from a single layer of the thin SIS biomaterial, a multilayered vessel was formed, which was several times thicker than the original SIS. The implanted graft supported the development of new artery tissue with an intimal lining of endothelial cells and a supporting outer layer of muscle tissue. This regeneration of tissue structures following implantation has been termed "smart remodeling" by researchers. A biomaterial with such properties was anticipated to provide a suitable covering for dermal wounds, and a pre-clinical animal study has specifically demonstrated the potential effectiveness of SIS as a biological-derived dressing in the clinical setting.
In this review, we report the results of a pilot study showing the initial clinical experiences with the wound matrix device (WMD) developed from the SIS biomaterial. A discussion of the need for and advantages associated with biological-derived dressings as compared to synthetic dressings is followed by a brief review of the discovery and development of the SIS biomaterial. The significant properties revealed in pre-clinical studies and the mechanisms behind the effective tissue restorative properties of the biomaterial are detailed. Finally, the initial clinical experiences with the WMD designed for dermal application and the development of other healthcare products from the SIS biomaterial are discussed.
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