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Twenty orthopaedic surgeons, sports medicine physicians, or basic scientists participated. Each participant was a Biologic Association member organization representative and asked to participate because of their active interest in the field of orthobiologics. Levels of consensus were delineated according to the number of votes for each statement: no consensus, &lt;80%; consensus, 80% to 89%; strong consensus, 90% to 99%; unanimous, 100%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The 26 consensus statements on orthobiologics resulted in 14 achieving unanimous consensus, 8 achieving strong consensus, 3 achieving consensus, and 1 did not achieve consensus. Overall, 85% of the statements reached either a unanimous or strong consensus. Of the statements regarding communication and transparency, 9 reached unanimous consensus, including information to convey and helpful tools to describe current orthobiologics, persistent misinformation, use of the word \u201cstem cells,\u201d \u201coff\u2010label\u201d use, and problems with the present regulatory environment. Five statements discussing the regulation of novel orthobiologics achieved unanimous consensus. These statements highlighted research regulation, safety, and suggested improvements to regulatory issues. The statement that did not achieve any consensus was on the regulatory processes that should be in place by an institution providing novel orthobiologic treatments. No statement reached a unanimous agreement on cost or ethical considerations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This study successfully identified key consensus statements emphasizing the importance of ethics, transparency, and regulation in the use of orthobiologics, with 85% of statements reaching unanimous or strong consensus. These findings underscore the need for standardized communication, improved regulatory frameworks, and enhanced safety measures while highlighting persistent challenges in addressing cost and ethical considerations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Level of Evidence<\/jats:title>\n                    <jats:p>Level V, expert opinion.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1016\/j.arthro.2025.01.062","type":"journal-article","created":{"date-parts":[[2025,2,10]],"date-time":"2025-02-10T19:14:31Z","timestamp":1739214871000},"page":"3611-3621","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":8,"title":["Experts Achieve Consensus on a Majority of Statements Regarding Ethics, Transparency, Regulation, and Best Practices for the Use of Orthobiologics"],"prefix":"10.1002","volume":"41","author":[{"given":"Ron","family":"Gilat","sequence":"first","affiliation":[{"name":"Midwest Orthopaedics at Rush University Medical Center Chicago Illinois U.S.A."},{"name":"Faculty of Medical and Health Sciences Tel Aviv University Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah A.","family":"Muth","sequence":"additional","affiliation":[{"name":"Midwest Orthopaedics at Rush University Medical Center Chicago Illinois U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eoghan T.","family":"Hurley","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery Duke University Durham North Carolina U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allen A.","family":"Yazdi","sequence":"additional","affiliation":[{"name":"Midwest Orthopaedics at Rush University Medical Center Chicago Illinois U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chloe H.","family":"Franzia","sequence":"additional","affiliation":[{"name":"Midwest Orthopaedics at Rush University Medical Center Chicago Illinois U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott A.","family":"Rodeo","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery Hospital for Special Surgery Sports Medicine Institute New York New York U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shane A.","family":"Shapiro","sequence":"additional","affiliation":[{"name":"Mayo Clinic College of Medicine and Science Mayo Clinic Department of Orthopedic Surgery Jacksonville Florida U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachel M.","family":"Frank","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery University of Colorado School of Medicine Denver Colorado U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian J.","family":"Cole","sequence":"additional","affiliation":[{"name":"Midwest Orthopaedics at Rush University Medical Center Chicago Illinois U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"Biologic Association Member Organization Representatives","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,2,10]]},"reference":[{"key":"e_1_2_4_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)32340-0"},{"key":"e_1_2_4_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.otsm.2020.150753"},{"key":"e_1_2_4_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00167-023-07423-x"},{"key":"e_1_2_4_5_1","doi-asserted-by":"publisher","DOI":"10.1177\/0363546517743746"},{"key":"e_1_2_4_6_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0090538"},{"key":"e_1_2_4_7_1","doi-asserted-by":"publisher","DOI":"10.1177\/03635465211018837"},{"key":"e_1_2_4_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.arthro.2017.11.036"},{"key":"e_1_2_4_9_1","doi-asserted-by":"publisher","DOI":"10.2106\/JBJS.18.00915"},{"key":"e_1_2_4_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.stem.2016.06.007"},{"key":"e_1_2_4_11_1","doi-asserted-by":"publisher","DOI":"10.5435\/JAAOS-D-16-00086"},{"key":"e_1_2_4_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.stem.2021.10.008"},{"key":"e_1_2_4_13_1","volume-title":"United States v Regenerative Sciences LLC. 878F, 248","author":"Civil Action No. 10\u20101327 (RMC)","year":"2012"},{"key":"e_1_2_4_14_1","doi-asserted-by":"publisher","DOI":"10.1097\/JSM.0000000000000973"},{"key":"e_1_2_4_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.arthro.2022.12.033"},{"key":"e_1_2_4_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.arthro.2023.08.020"},{"key":"e_1_2_4_17_1","unstructured":"CFR \u2010 Code of Federal Regulations Title 21https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=1271&showFR=1. 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