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Peripheral blood mononuclear cell (PB-MNCs) therapy has emerged as a promising adjunctive strategy, but long-term data remain limited. The study aimed to evaluate the long-term outcomes of PB-MNC therapy in patients with DFUs and NO-CLTI.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This prospective, single-centre, observational, controlled study included patients with ischaemic DFUs and no-option CLTI enrolled between January 2017 and September 2023. No-option CLTI was defined by a technical failure of lower limb revascularization with the absence of any below-the-ankle vessel and\/or indirect revascularization with TcPO\u2082 values\u2009&lt;\u200930 mmHg in the wound angiosome area. Patients were divided into two groups: those receiving PB-MNCs therapy plus standard of care (SoC) and those treated only with SOC based on conventional guidelines. PB-MNCs were administered by intramuscular injections along the anatomical area of the wound-related artery (2 or 3 cycles, 21\u201342 days apart). At 24 months of follow-up, outcomes assessed were healing, major amputation, and mortality. In the PB-MNC group, hospital readmission for recurrent CLTI requiring repeat revascularization was also recorded.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Overall, 78 patients were included: 48 in the PB-MNCs group and 30 in the conventional therapy group. The mean age was 73.7 years, 84.6% were male, and most had type 2 diabetes (92.3%). At the baseline assessment, 71.8% of DFUs were infected, 83.3% were &gt;\u20095\u00a0cm\u00b2, and 88.5% had gangrene. At 24 months, the PB-MNCs group showed a higher rate of healing (60.4 vs. 20%,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.0001), lower rate of major amputation (12.5 vs. 26.7%,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.0004), and mortality (27.1 vs. 46.7%,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.0002) than the control group. CLTI recurrence requiring readmission occurred in 3\/48 (6.2%) among patients in the PB-MNC group.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In patients with ischaemic DFUs and NO-CLTI, adjunctive PB-MNCs therapy was associated with better long-term outcomes in comparison to conventional therapy.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00592-026-02721-5","type":"journal-article","created":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T06:55:42Z","timestamp":1782111342000},"page":"1447-1457","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Long-term outcomes of autologous cell therapy in patients with ischaemic diabetic foot ulcers and no-option chronic limb threatening ischaemia"],"prefix":"10.1007","volume":"63","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3789-9622","authenticated-orcid":false,"given":"Meloni","family":"Marco","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bellizzi","family":"Ermanno","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Uccioli","family":"Luigi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Morosetti","family":"Daniele","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giurato","family":"Laura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bonanni Federico","family":"Rolando","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruotolo","family":"Valeria","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreadi","family":"Aikaterini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bellia","family":"Alfonso","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lauro","family":"Davide","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,6,22]]},"reference":[{"issue":"3","key":"2721_CR1","doi-asserted-by":"publisher","first-page":"e3747","DOI":"10.1002\/dmrr.3747","volume":"40","author":"PA Lazzarini","year":"2024","unstructured":"Lazzarini PA, Raspovic KM, Meloni M, van Netten JJ (2024) A new declaration for feet\u2019s sake: Halving the global diabetic foot disease burden from 2% to 1% with next generation care. 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