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

Autor: Andrea Panunzi, Fabiana Madotto, Elena Sangalli, Federica Riccio, Adriana Barbara Sganzaroli, Paolo Galenda, Amelia Bertulessi, Maria Francesca Barmina, Ornella Ludovico, Orazio Fortunato, Francesco Setacci, Flavio Airoldi, Davide Tavano, Laura Giurato, Marco Meloni, Luigi Uccioli, Antonino Bruno, Gaia Spinetti, Carlo Maria Ferdinando Caravaggi
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Cardiovascular Diabetology, Vol 21, Iss 1, Pp 1-10 (2022)
Druh dokumentu: article
ISSN: 1475-2840
DOI: 10.1186/s12933-022-01629-y
Popis: Abstract 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
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