{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,6]],"date-time":"2026-06-06T13:27:44Z","timestamp":1780752464912,"version":"3.54.1"},"reference-count":23,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2018,12,26]],"date-time":"2018-12-26T00:00:00Z","timestamp":1545782400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Laryngoscope"],"published-print":{"date-parts":[[2019,8]]},"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>Ideal long\u2010term vocal fold augmentation materials should be biocompatible, easily administered, allow tissue integration for long\u2010term effect, and remain at the site of injection. A novel silk protein particle suspended in hyaluronic acid (Silk\u2010HA) has been developed specifically for vocal fold augmentation to address this unmet need. This article presents the 6\u2010month, preclinical findings of a canine vocal fold injection trial for Silk\u2010HA.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Twelve beagle dogs were injected transorally in the lateral\/deep aspect of their right thyroarytenoid muscles with 0.3 cc of Silk\u2010HA or calcium hydroxylapatite in carboxymethyl cellulose (CaHA\u2010CMC). The Silk\u2010HA particle injectable was delivered via a custom catheter, whereas CaHA\u2010CMC was delivered through a commercially available malleable needle. The six dogs from each material group were sacrificed 6 months from the injection date for the evaluation of implant longevity, immune response, and material migration.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Silk\u2010HA provides immediate medialization of the right vocal fold, lasting for a minimum of 6 months in a canine model. Silk\u2010HA and CaHA\u2010CMC both demonstrate similar inflammatory responses. The Silk\u2010HA was shown to remain without migration at the site of injection in all six canine subjects, whereas CaHA\u2010CMC demonstrated migration in four of the six canines. In two canines implanted with CaHA\u2010CMC, material was discovered to migrate to the retropharyngeal lymph nodes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>In a canine subject model, the Silk\u2010HA material compares favorably in terms of longevity and immune response to CaHA\u2010CMC. The lack of migration of the Silk\u2010HA material demonstrates a promising potential for vocal fold injection in the clinic.<\/jats:p><\/jats:sec><jats:sec><jats:title>Level of Evidence<\/jats:title><jats:p>NA<\/jats:p><jats:p><jats:italic>Laryngoscope<\/jats:italic>, 129:1856\u20131862, 2019<\/jats:p><\/jats:sec>","DOI":"10.1002\/lary.27618","type":"journal-article","created":{"date-parts":[[2018,12,27]],"date-time":"2018-12-27T06:50:25Z","timestamp":1545893425000},"page":"1856-1862","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":33,"title":["A novel silk\u2010based vocal fold augmentation material: 6\u2010month evaluation in a canine model"],"prefix":"10.1002","volume":"129","author":[{"given":"Christopher P.","family":"Gulka","sequence":"first","affiliation":[{"name":"Sofregen Medical, Inc.  Medford"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9636-9480","authenticated-orcid":false,"given":"Joseph E.","family":"Brown","sequence":"additional","affiliation":[{"name":"Sofregen Medical, Inc.  Medford"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jodie E.M.","family":"Giordano","sequence":"additional","affiliation":[{"name":"Sofregen Medical, Inc.  Medford"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer E.","family":"Hickey","sequence":"additional","affiliation":[{"name":"Sofregen Medical, Inc.  Medford"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria P.","family":"Montero","sequence":"additional","affiliation":[{"name":"Sofregen Medical, Inc.  Medford"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anh","family":"Hoang","sequence":"additional","affiliation":[{"name":"Sofregen Medical, Inc.  Medford"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5666-2482","authenticated-orcid":false,"given":"Thomas L.","family":"Carroll","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology Brigham and Women's Hospital  Boston Massachusetts U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,12,26]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.3342\/ceo.2010.3.4.177"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.20712"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1177\/000348949510400702"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1177\/019459988709600111"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/hed.2880130516"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1097\/00005537-200303000-00027"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.21258"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvoice.2004.02.001"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvoice.2011.08.005"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.progpolymsci.2007.05.013"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12917-015-0379-8"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvoice.2018.01.017"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1177\/000348940411300402"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1177\/000348940411300114"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1177\/000348940010900219"},{"key":"e_1_2_6_17_1","first-page":"717","volume-title":"Miller's Anatomy of the Dog","author":"Evans HE","year":"1993"},{"key":"e_1_2_6_18_1","first-page":"405","volume-title":"Textbook of Veterinary Anatomy","author":"Dyce KM","year":"2010"},{"key":"e_1_2_6_19_1","first-page":"535","volume-title":"Miller's Anatomy of the Dog","author":"Evans HE","year":"2013"},{"key":"e_1_2_6_20_1","volume-title":"Ear, Nose and Throat Diseases of the Dog and Cat","author":"Harvey RG","year":"2017"},{"key":"e_1_2_6_21_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF00190068"},{"key":"e_1_2_6_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF00455154"},{"key":"e_1_2_6_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5347(01)67398-1"},{"key":"e_1_2_6_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/1097-4636(2000)53:6<646::AID-JBM5>3.0.CO;2-0"}],"container-title":["The Laryngoscope"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Flary.27618","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/lary.27618","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,10]],"date-time":"2023-09-10T04:58:24Z","timestamp":1694321904000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/lary.27618"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,12,26]]},"references-count":23,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2019,8]]}},"alternative-id":["10.1002\/lary.27618"],"URL":"https:\/\/doi.org\/10.1002\/lary.27618","archive":["Portico"],"relation":{},"ISSN":["0023-852X","1531-4995"],"issn-type":[{"value":"0023-852X","type":"print"},{"value":"1531-4995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,12,26]]},"assertion":[{"value":"2018-03-21","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-09-17","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-12-26","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}