{"id":3253,"date":"2026-02-02T13:45:00","date_gmt":"2026-02-02T05:45:00","guid":{"rendered":"https:\/\/www.cytopeutics.com\/?p=3253"},"modified":"2026-02-02T20:10:36","modified_gmt":"2026-02-02T12:10:36","slug":"combination-bm-msc-with-bm-mnc-is-better-than-bm-mnc-alone-in-resolution-of-large-ischemic-ulcers-a-phase-ll-lll-clinical-randomized-study","status":"publish","type":"post","link":"https:\/\/www.cytopeutics.com\/zh-hans\/abstracts-publication\/foot-ulcer-poor-healing-wound\/combination-bm-msc-with-bm-mnc-is-better-than-bm-mnc-alone-in-resolution-of-large-ischemic-ulcers-a-phase-ll-lll-clinical-randomized-study\/\u00a0","title":{"rendered":"Combination BM-MSC with BM-MNC is better than BM-MNC alone in resolution of large ischemic ulcers: A phase ll\/lll clinical randomized study."},"content":{"rendered":"\t\t
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Affiliation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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  1. Department of Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia<\/span><\/li>
  2. Cytopeutics, Selangor, Malaysia<\/span><\/li>
  3. Tunku Abdul Rahman University, Selangor, Malaysia<\/span><\/li>
  4. Cell Therapy Centre, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia<\/span><\/li><\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Background<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    We previously demonstrated that combination bone marrow derived cultured mesenchymal stromal cell (BM-MSC) with bone marrow derived unselected mononuclear cell (BM-MNC) may help induce angiogenesis in diabetic patients with critical limb ischemia. In this new randomized Phase II\/III clinical trial, we compared autologous BM-MSC with BM-MNC (Group A) versus BM-MNC alone (Group B) in severe lower limb ulcers secondary to critical limb ischemia with the aim of avoiding amputations.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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    Methods<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Seven consecutive patients were randomized and underwent bone marrow aspiration (BMA) to collect 500mls that was then centrifuged and separated to obtain the unselected BM-MNC fraction. Group A (N = 3) patients underwent intra-muscular injection of the BM-MNC 1 hour after BMA on the affected limb, followed by intra-muscular injection of in-vitro expanded BM-MSC. Group B (N = 4) patients underwent injection of BM-MNC after BMA only. One patient in Group B had ulcers on each leg.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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    Results <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    All patients tolerated the BMA and injection well. The ulcer size at baseline, 1 month, 2 months and 5 months were as follows: Group A (22.5\u00b114.2 vs. 6.3\u00b110.1, 2.5\u00b13.5, 0.0\u00b10.0cm\u00b2; p = 0.07) Group B (25.4\u00b112.0 vs. 29.1\u00b122.8, 45.2\u00b141.7, 54.8\u00b152.7cm\u00b2; p = 0.84). All ulcers in Group A were completely healed by 5 months irrespective of baseline size (10-38cm\u00b2). In Group B, 2 ulcers (both smaller than 20 cm\u00b2) resolved while 3 ulcers (all greater than 20cm\u00b2) enlarged in size. Digital subtraction angiography (DSA) showed restoration of peripheral blood flow in all Group A patients. However, there were no difference in ankle brachial index at baseline to end of follow-up within both groups.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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    Conclusion<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    We have demonstrated that BM-MSC with BM-MNC is superior to BM-MNC alone in the resolution of severe foot ulcer secondary to critical limb ischemia, particularly for large ulcers.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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    \n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tFull paper link<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

    Affiliation Department of Surgery, Faculty of Medicine, […]<\/p>\n","protected":false},"author":1,"featured_media":3256,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35,44],"tags":[],"class_list":["post-3253","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-diabetes-complications","category-foot-ulcer-poor-healing-wound"],"acf":[],"yoast_head":"\nCombination BM-MSC with BM-MNC is better than BM-MNC alone in resolution of large ischemic ulcers: A phase ll\/lll clinical randomized study. - Cytopeutics<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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