The DOI matches its Crossref record.
Porcine small intestine submucosa (SIS) is not an acellular collagenous matrix and contains porcine DNA: Possible implications in human implantation
Abstract
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 noninfectious edema 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 DAP12 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 DAP12 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. © 2005 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 73B: 61–67, 2005
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
No references could be resolved yet.
Research works printed but not linked: 18
- 10.1002/jbm.a.10144 · DOI
- 10.1016/0022-4804(89)90050-4 · DOI
- 10.1002/jbm.820290809 · DOI
- 10.1016/S0090-3019(97)00475-8 · DOI
- 10.1177/03635465010290021001 · DOI · Paper page
- Gu Y, 2002, Substitution of porcine small intestinal submucosa for rabbit Achilles tendon, an experimental study, Zhonghua Yi Xue Za Zhi, 82, 1279
- 10.1007/s003450050064 · DOI
- 10.3109/08941939009140351 · DOI
- 10.1080/089419399272395 · DOI
- John BD, 1990, Theory and practice of histological techniques, 407
- 10.1136/mp.49.3.M176 · DOI
- 10.1007/s002510050642 · DOI
- 10.3109/17453679709004002 · DOI
- 10.1034/j.1600-0455.2002.430221.x · DOI
- Timpl R, 1984, Extracellular matrix biochemistry, 118
- Wallace DG, 1988, Collagen biotechnology, 118
- Woo SL‐Y, 1988, Injury and repair of musculoskeletal soft tissues, 133
- 10.1097/01.ju.0000083802.87337.af · DOI
Cited by
An overview of tissue and whole organ decellularization processes
Crapo, P. M., Gilbert, T. W., & Badylak, S. F. (2011) · Biomaterials · doi:10.1016/j.biomaterials.2011.01.057 · Cited by 3,591
Scaffolding in tissue engineering: general approaches and tissue-specific considerations
Chan, B. P., & Leong, K. W. (2008) · European Spine Journal · doi:10.1007/s00586-008-0745-3 · Cited by 1,708
Immune response to biologic scaffold materials
Badylak, S. F., & Gilbert, T. W. (2008) · Seminars in Immunology · doi:10.1016/j.smim.2007.11.003 · Cited by 857
Consequences of ineffective decellularization of biologic scaffolds on the host response
Keane, T. J., Londono, R., Turner, N. J., & Badylak, S. F. (2012) · Biomaterials · doi:10.1016/j.biomaterials.2011.10.054 · Cited by 613
Processing of collagen based biomaterials and the resulting materials properties
Meyer, M. (2019) · BioMedical Engineering OnLine · doi:10.1186/s12938-019-0647-0 · Cited by 539
Extracellular matrix-based biomaterial scaffolds and the host response
Aamodt, J. M., & Grainger, D. W. (2016) · Biomaterials · doi:10.1016/j.biomaterials.2016.02.003 · Cited by 509
Macrophage Participation in the Degradation and Remodeling of Extracellular Matrix Scaffolds
Valentin, J. E., Stewart-Akers, A. M., Gilbert, T. W., & Badylak, S. F. (2009) · Tissue Engineering Part A · doi:10.1089/ten.tea.2008.0419 · Cited by 356
Strategies for tissue and organ decellularization
Gilbert, T. W. (2012) · Journal of Cellular Biochemistry · doi:10.1002/jcb.24130 · Cited by 267
Golebiowska, A. A., Intravaia, J. T., Sathe, V. M., Kumbar, S. G., & Nukavarapu, S. P. (2024) · Bioactive Materials · doi:10.1016/j.bioactmat.2023.09.017 · Cited by 236
Decellularization for whole organ bioengineering
Arenas-Herrera, J. E., Ko, I. K., Atala, A., & Yoo, J. J. (2013) · Biomedical Materials · doi:10.1088/1748-6041/8/1/014106 · Cited by 221
Biocompatibility evaluation of tissue-engineered decellularized scaffolds for biomedical application
Hussein, K. H., Park, K.-M., Kang, K.-S., & Woo, H.-M. (2016) · Materials Science and Engineering: C · doi:10.1016/j.msec.2016.05.068 · Cited by 218
Yang, B., Zhang, Y., Zhou, L., Sun, Z., Zheng, J., Chen, Y., & Dai, Y. (2010) · Tissue Engineering Part C: Methods · doi:10.1089/ten.tec.2009.0311 · Cited by 206
Sabetkish, S., Kajbafzadeh, A.-M., Sabetkish, N., Khorramirouz, R., Akbarzadeh, A., Seyedian, S. L., Pasalar, P., Orangian, S., Beigi, R. S. H., Aryan, Z., et al. (2015) · Journal of Biomedical Materials Research Part A · doi:10.1002/jbm.a.35291 · Cited by 152
Regulation of decellularized matrix mediated immune response
Chakraborty, J., Roy, S., & Ghosh, S. (2020) · Biomaterials Science · doi:10.1039/c9bm01780a · Cited by 130
Böer, U., Lohrenz, A., Klingenberg, M., Pich, A., Haverich, A., & Wilhelmi, M. (2011) · Biomaterials · doi:10.1016/j.biomaterials.2011.09.015 · Cited by 107
Keeping an Eye on Decellularized Corneas: A Review of Methods, Characterization and Applications
Wilson, S., Sidney, L., Dunphy, S., Rose, J., & Hopkinson, A. (2013) · Journal of Functional Biomaterials · doi:10.3390/jfb4030114 · Cited by 100
Capella-Monsonís, H., Crum, R. J., Hussey, G. S., & Badylak, S. F. (2024) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2024.115347 · Cited by 84
Struecker, B., Butter, A., Hillebrandt, K., Polenz, D., Reutzel-Selke, A., Tang, P., Lippert, S., Leder, A., Rohn, S., Geisel, D., et al. (2017) · Journal of Tissue Engineering and Regenerative Medicine · doi:10.1002/term.1948 · Cited by 65
Wu, L.-C., Kuo, Y.-J., Sun, F.-W., Chen, C.-H., Chiang, C.-J., Weng, P.-W., Tsuang, Y.-H., & Huang, Y.-Y. (2017) · Cell and Tissue Banking · doi:10.1007/s10561-017-9619-4 · Cited by 59
Casarin, M., Fortunato, T. M., Imran, S., Todesco, M., Sandrin, D., Borile, G., Toniolo, I., Marchesan, M., Gerosa, G., Bagno, A., et al. (2022) · International Journal of Molecular Sciences · doi:10.3390/ijms23052826 · Cited by 58
Zhang, X., Yang, J., Li, Y., Liu, S., Long, K., Zhao, Q., Zhang, Y., Deng, Z., & Jin, Y. (2011) · Tissue Engineering Part C: Methods · doi:10.1089/ten.tec.2010.0466 · Cited by 56
Hussein, K. H., Ahmadzada, B., Correa, J. C., Sultan, A., Wilken, S., Amiot, B., & Nyberg, S. L. (2024) · Bioactive Materials · doi:10.1016/j.bioactmat.2024.06.001 · Cited by 28
“Several researchers have emphasized the importance of residual DNA within scaffolds derived from porcine sources and its implications for immune responses post-implantation [60 – 62].”
BackgroundFazel Anvari Yazdi, A., Tahermanesh, K., Ejlali, M., Babaei-Ghazvini, A., Acharya, B., Badea, I., MacPhee, D. J., & Chen, X. (2024) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2024.1418034 · Cited by 13
Metadata
- Authors
- Zheng, M. H., Chen, J., Kirilak, Y., Willers, C., Xu, J., & Wood, D.
- Venue
- Journal of Biomedical Materials Research Part B: Applied Biomaterials
- Publisher
- Wiley
- Published
- 2005-02-25
- Volume
- 73B
- Issue
- 1
- Pages
- 61-67
- ISSN
- 1552-4973 (ISSN-L)
- 1552-4981
- OpenAlex
- W1983772892
- Cited by
- 441
- References
- 0
- FWCI
- 12.35
- Type
- journal article
- Language
- en
- Open access
- closed
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
Data sources
Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
