{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T20:39:32Z","timestamp":1792528772442,"version":"4.5.0"},"reference-count":61,"publisher":"Springer Science and Business Media LLC","license":[{"start":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T00:00:00Z","timestamp":1792454400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T00:00:00Z","timestamp":1792454400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Eur Spine J"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Regenerative medicine (RM) trials for intervertebral disc degeneration (IDD) are gaining increasing visibility and clinical relevance, yet reporting quality remains inconsistent and often incomplete. Critical details on trial methodology, biologic product specifications, imaging criteria, and outcome assessment are frequently insufficiently reported, limiting reproducibility and hindering the interpretation of available evidence. The aim of this study was to develop a spine-specific reporting guideline to support authors, reviewers, and readers in producing transparent and interpretable RM clinical trial reports.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A three-stage process was undertaken to establish a consensus-based reporting guideline. First, a systematic review of published RM trials employing intradiscal biologic treatments was conducted to identify recurring reporting deficiencies. Second, an expert focus group and subsequent international survey hosted by the International Society for the Study of the Lumbar Spine (ISSLS) generated and prioritized candidate reporting items. Third, the finalized VERTEBRA checklist was applied to an updated cohort of clinical trials to evaluate reporting completeness across predefined domains.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Across 36 eligible clinical trials, the mean VERTEBRA completeness score was 53.8%, with substantial variability among studies. Recurrent deficiencies were consistently observed in product characterization, methodological transparency, imaging acquisition and analysis, baseline reporting, and management of missing data. Only a minority of studies referenced established reporting guidelines. Reporting quality showed an association with journal impact factor, but not geographic region or funding disclosures. Expert polling demonstrated strong agreement on the need for a spine-specific reporting tool, resulting in the development of a 50-item checklist organized across five domains.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The VERTEBRA reporting guideline provides a structured, field-specific framework to elevate transparency, reproducibility, and interpretability in RM trials for IDD. Its adoption may enhance manuscript quality, strengthen peer review, and improve the reliability of evidence guiding the development and clinical translation of future regenerative therapies for IDD.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00586-026-10373-w","type":"journal-article","created":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T03:38:35Z","timestamp":1792467515000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["The ISSLS VERTEBRA initiative: establishing reporting standards for regenerative medicine trials in disc degeneration and low back 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He is also an inventor on multiple patents and patent applications assigned to Tokai University and\/or Nippon Zoki Pharmaceutical Co., Ltd., related to nucleus pulposus cell evaluation, intervertebral disc regeneration, and the culture of Tie2-positive stem\/progenitor cell-containing populations. Relevant granted patents include JP5863639B2, JP6712740B1, JP6779492B2, JP6905234B2, JP7421182B2, JP7554436B2, and JP7626993B2, as well as earlier foundational patents, including JP4036881B2 (expired). In addition, Jordy Schol and Daisuke Sakai are co-inventors on patents assigned to Tokai University and\/or Kyoto University related to transcription factor-based generation of nucleus pulposus and progenitor cells (JP7298858B2 and JP7388755B2). A full list of conflict of interest is listed in Supplemental data for members of the VERTEBRA Working Group (Supplemental Data 4).","order":1,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Ethics approval was not sought because the focus-group discussions and online survey were conducted as professional consultation activities for the development of a reporting guideline. The focus groups were held as voluntary workshops during the ISSLS Annual Meetings. CONSENT TO PARTICIPATE: Participation in the focus-group workshops and online survey was voluntary. Participants provided professional opinions on proposed checklist items, and findings were reported only in aggregate. CONSENT TO PUBLISH: All contributors were contacted by email and provided consent to be identified by name as members of the VERTEBRA Working Group in the manuscript.","order":2,"name":"Ethics","label":"Ethics approval and consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}}]}}