{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T15:34:38Z","timestamp":1792510478674,"version":"4.5.0"},"reference-count":31,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,6,2]],"date-time":"2025-06-02T00:00:00Z","timestamp":1748822400000},"content-version":"vor","delay-in-days":1,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003196","name":"Ministero della Salute","doi-asserted-by":"publisher","award":["F84I20000170001"],"award-info":[{"award-number":["F84I20000170001"]}],"id":[{"id":"10.13039\/501100003196","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100003196","name":"Ministero della Salute","doi-asserted-by":"publisher","award":["project CUP code F84I20000170001"],"award-info":[{"award-number":["project CUP code F84I20000170001"]}],"id":[{"id":"10.13039\/501100003196","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["JOR Spine"],"published-print":{"date-parts":[[2025,6]]},"abstract":"ABSTRACT<\/jats:title>Background<\/jats:title>Low back pain (LBP) is a leading cause of disability worldwide, often associated with intervertebral disc degeneration (IDD). Mesenchymal stromal cells (MSCs) have emerged as a promising regenerative therapy for IDD due to their ability to promote tissue repair. This phase IIB randomized controlled trial aimed to evaluate the safety and efficacy of autologous bone marrow\u2010derived MSC (BM\u2010MSC) intradiscal injections in patients with chronic LBP due to moderate\u2010to\u2010advanced multilevel IDD.<\/jats:p><\/jats:sec>Methods<\/jats:title>Fifty\u2010two patients with chronic LBP unresponsive to conservative treatments with moderate\u2010to\u2010advanced IDD at up to three lumbar levels were included. Participants were randomized to receive either BM\u2010MSCs or a sham procedure. Clinical outcomes, including pain intensity (VAS), disability (ODI), and quality of life (SF\u201036), were assessed at baseline, 1\u2010, 3\u2010, and 6\u2010months postinjection. Structural changes were evaluated via MRI using Pfirrmann grading, disc height index (DHI), and T2 mapping at baseline, 3 and 6\u2009months.<\/jats:p><\/jats:sec>Results<\/jats:title>Of the 52 enrolled patients, 46 completed the 6\u2010month follow\u2010up (BM\u2010MSC group: n<\/jats:italic>\u2009=\u200921; sham group: n<\/jats:italic>\u2009=\u200925). BM\u2010MSC injections were well\u2010tolerated, with no major adverse events\u00a0reported. Structural improvements were observed in the BM\u2010MSC group, including significant increases in DHI and nonsignificant improvements in T2 relaxation times at 3 and 6\u2009months. Modified Pfirrmann grades showed transient improvement at 3\u2009months but returned to baseline at 6\u2009months. Despite these radiological changes, clinical outcomes such as VAS, ODI, and SF\u201036 scores improved similarly in both groups without significant intergroup differences at any timepoint. The sham group demonstrated slightly greater improvements in disability (ODI) and physical quality\u2010of\u2010life scores (SF\u201036 PCS).<\/jats:p><\/jats:sec>Conclusions<\/jats:title>Autologous BM\u2010MSC intradiscal injection is a safe and promising approach in patients with chronic LBP due to moderate\u2010to\u2010advanced multilevel IDD. However, despite these regenerative effects, no significant clinical advantages over the sham procedure were observed within 6\u2009months of follow\u2010up.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jsp2.70086","type":"journal-article","created":{"date-parts":[[2025,6,3]],"date-time":"2025-06-03T03:44:01Z","timestamp":1748922241000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Intradiscal Mesenchymal Stromal Cell Therapy for the Treatment of Low Back Pain Due to Moderate\u2010to\u2010Advanced Multilevel Disc Degeneration: A Preliminary Report of a Double\u2010Blind, Phase IIB<\/scp> Randomized Clinical Trial (DREAM<\/scp> Study)"],"prefix":"10.1002","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7142-1660","authenticated-orcid":false,"given":"Gianluca","family":"Vadal\u00e0","sequence":"first","affiliation":[{"name":"Operative Research Unit of Orthopaedic and Trauma Surgery Fondazione Policlinico Universitario Campus Bio\u2010Medico Rome Italy"},{"name":"Laboratory for Regenerative Orthopaedics, Research Unit of Orthopaedic and Trauma Surgery Department of Medicine and Surgery, Universit\u00e0 Campus Bio\u2010Medico di Roma Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabrizio","family":"Russo","sequence":"additional","affiliation":[{"name":"Operative Research Unit of Orthopaedic and Trauma Surgery Fondazione Policlinico Universitario Campus Bio\u2010Medico Rome Italy"},{"name":"Laboratory for Regenerative Orthopaedics, Research Unit of Orthopaedic and Trauma Surgery Department of Medicine and Surgery, Universit\u00e0 Campus Bio\u2010Medico di Roma Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristiana","family":"Lavazza","sequence":"additional","affiliation":[{"name":"Unit of Cell and Gene Therapies Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milano Milan 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