{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T13:40:55Z","timestamp":1787665255674,"version":"build-2736575974"},"reference-count":25,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2021,5,14]],"date-time":"2021-05-14T00:00:00Z","timestamp":1620950400000},"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":[[2022,3]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives\/Hypothesis<\/jats:title>\n                    <jats:p>To evaluate the safety and potential efficacy of autologous muscle\u2010derived cells (AMDCs) for the treatment of swallowing impairment following treatment for oropharynx cancer.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Design<\/jats:title>\n                    <jats:p>Prospective, phase I, open label, clinical trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Oropharynx cancer survivors disease free \u22652\u2009years post chemoradiation were recruited. All patients had swallowing impairment but were not feeding tube dependent (Functional Oral Intake Scale [FOIS]\u2009\u2265\u20095). Muscle tissue (50\u2013250\u2009mg) was harvested from the vastus lateralis and 150\u2009\u00d7\u200910\n                      <jats:sup>6<\/jats:sup>\n                      AMDCs were prepared (Cook MyoSite Inc., Pittsburgh, PA). The cells were injected into four sites throughout the intrinsic tongue musculature. Participants were followed for 24\u2009months. The primary outcome measure was safety. Secondary endpoints included objective measures on swallowing fluoroscopy, oral and pharyngeal pressure, and changes in patient\u2010reported outcomes.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Ten individuals were enrolled. 100% (10\/10) were male. The mean age of the cohort was 65 (\u00b18.87) years. No serious adverse event occurred. Mean tongue pressure increased significantly from 26.3 (\u00b111.1) to 31.8 (\u00b19.5) kPa (\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a0.017). The mean penetration\u2010aspiration scale did not significantly change from 5.6 (\u00b12.1) to 6.8 (\u00b11.8), and the mean FOIS did not significantly change from 5.4 (\u00b10.5) to 4.6 (\u00b10.7). The incidence of pneumonia was 30% (3\/10) and only 10% (1\/10) experienced deterioration in swallowing function throughout 2\u2009years of follow\u2010up. The mean eating assessment tool (EAT\u201010) did not significantly change from 24.1 (\u00b15.57) to 21.3 (\u00b16.3) (\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a0.12).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      Results of this phase I clinical trial demonstrate that injection of 150\u2009\u00d7\u200910\n                      <jats:sup>6<\/jats:sup>\n                      AMDCs into the tongue is safe and may improve tongue strength, which is durable at 2\u2009years. A blinded placebo\u2010controlled trial is warranted.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Level of Evidence<\/jats:title>\n                    <jats:p>\n                      3\n                      <jats:italic>Laryngoscope<\/jats:italic>\n                      , 132:523\u2013527, 2022\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/lary.29606","type":"journal-article","created":{"date-parts":[[2021,5,14]],"date-time":"2021-05-14T07:54:27Z","timestamp":1620978867000},"page":"523-527","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Autologous Muscle\u2010Derived Cell Therapy for Swallowing Impairment in Patients Following Treatment for Head and Neck Cancer"],"prefix":"10.1002","volume":"132","author":[{"given":"Nogah","family":"Nativ\u2010Zeltzer","sequence":"first","affiliation":[{"name":"Department of Otolaryngology\u2010Head and Neck Surgery University of California, Davis Medical Center  Sacramento California U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maggie A.","family":"Kuhn","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2010Head and Neck Surgery University of California, Davis Medical Center  Sacramento California U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Evangelista","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2010Head and Neck Surgery University of California, Davis Medical Center  Sacramento California U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johnathon D.","family":"Anderson","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2010Head and Neck Surgery University of California, Davis Medical Center  Sacramento California U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan A.","family":"Nolta","sequence":"additional","affiliation":[{"name":"Institute for Regenerative Cures, Department of Internal Medicine University of California, Davis  Sacramento California U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D. Gregory","family":"Farwell","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2010Head and Neck Surgery University of California, Davis Medical Center  Sacramento California U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emanuele","family":"Canestrari","sequence":"additional","affiliation":[{"name":"Cook MyoSite, Inc.  Pittsburgh Pennsylvania U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ron J.","family":"Jankowski","sequence":"additional","affiliation":[{"name":"Cook MyoSite, Inc.  Pittsburgh Pennsylvania U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter C.","family":"Belafsky","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2010Head and Neck Surgery University of California, Davis Medical Center  Sacramento California U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,5,14]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00405-015-3680-z"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/archotol.126.3.384"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/hed.26059"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00455-013-9500-y"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/cam4.3599"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.27631"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1080\/2090598X.2020.1750864"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11255-018-2005-8"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13287-018-0978-y"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.12659\/AJCR.883903"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1097\/00005537-200310000-00025"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/archfaci.5.5.403"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.26666"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.24352"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00455-009-9258-4"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF00417897"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1242\/dev.069088"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/nan.12198"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/hed.20325"},{"key":"e_1_2_6_21_1","doi-asserted-by":"publisher","DOI":"10.1038\/mt.2013.155"},{"key":"e_1_2_6_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2017.03.006"},{"key":"e_1_2_6_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/hed.23275"},{"key":"e_1_2_6_24_1","doi-asserted-by":"publisher","DOI":"10.1001\/archotol.134.12.1299"},{"key":"e_1_2_6_25_1","doi-asserted-by":"publisher","DOI":"10.1093\/gerona\/50A.5.M257"},{"key":"e_1_2_6_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00345-019-03018-9"}],"container-title":["The Laryngoscope"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/lary.29606","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/lary.29606","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/lary.29606","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,27]],"date-time":"2023-08-27T02:28:50Z","timestamp":1693103330000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/lary.29606"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,5,14]]},"references-count":25,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2022,3]]}},"alternative-id":["10.1002\/lary.29606"],"URL":"https:\/\/doi.org\/10.1002\/lary.29606","archive":["Portico"],"relation":{},"ISSN":["0023-852X","1531-4995"],"issn-type":[{"value":"0023-852X","type":"print"},{"value":"1531-4995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,5,14]]},"assertion":[{"value":"2021-03-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-04-19","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-05-14","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}