Results of a prospective observational study of autologous peripheral blood mononuclear cell therapy for no-option critical limb-threatening ischemia and severe diabetic foot ulcers

التفاصيل البيبلوغرافية
العنوان: Results of a prospective observational study of autologous peripheral blood mononuclear cell therapy for no-option critical limb-threatening ischemia and severe diabetic foot ulcers
المؤلفون: Panunzi, Andrea, Madotto, Fabiana, Sangalli, Elena, Riccio, Federica, Sganzaroli, Adriana Barbara, Galenda, Paolo, Bertulessi, Amelia, Barmina, Maria Francesca, Ludovico, Ornella, Fortunato, Orazio, Setacci, Francesco, Airoldi, Flavio, Tavano, Davide, Giurato, Laura, Meloni, Marco, Uccioli, Luigi, Bruno, Antonino, Spinetti, Gaia, Caravaggi, Carlo Maria Ferdinando
سنة النشر: 2022
المجموعة: Zenodo
الوصف: Background: Cell therapy with autologous peripheral blood mononuclear cells (PB-MNCs) may help restore limb perfusion in patients with diabetes mellitus and critical limb-threatening ischemia (CLTI) deemed not eligible for revascularization procedures and consequently at risk for major amputation (no-option). Fundamental is to establish its clinical value and to identify candidates with a greater benefit over time. Assessing the frequency of PB circulating angiogenic cells and extracellular vesicles (EVs) may help in guiding candidate selection. Methods: We conducted a prospective, non-controlled, observational study on no-option CLTI diabetic patients that underwent intramuscular PB-MNCs therapy, which consisted of more cell treatments repeated a maximum of three times. The primary endpoint was amputation rate at 1 year following the first treatment with PB-MNCs. We evaluated ulcer healing, walking capability, and mortality during the follow-up period. We assessed angiogenic cells and EVs at baseline and after each cell treatment, according to primary outcome and tissue perfusion at the last treatment [measured as transcutaneous oxygen pressure ( TcPO2)]. Results: 50 patients were consecutively enrolled and the primary endpoint was 16%. TcPO2 increased after PB-MNCs therapy (17.2 ± 11.6 vs 39.1 ± 21.8 mmHg, p < .0001), and ulcers healed with back-to-walk were observed in 60% of the study population (88% of survivors) during follow-up (median 1.5 years). Patients with a high level of TcPO2 (≥ 40 mmHg) after the last treatment showed a high frequency of small EVs at enrollment.
نوع الوثيقة: dataset
اللغة: unknown
العلاقة: https://zenodo.org/communities/multimedicaTest; https://zenodo.org/record/7603201Test; https://doi.org/10.1186/s12933-022-01629-yTest; oai:zenodo.org:7603201
DOI: 10.1186/s12933-022-01629-y
الإتاحة: https://doi.org/10.1186/s12933-022-01629-yTest
https://zenodo.org/record/7603201Test
حقوق: info:eu-repo/semantics/restrictedAccess
رقم الانضمام: edsbas.57C9690
قاعدة البيانات: BASE