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
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Le résumé fourni par la source
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 < .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. Conclusions In no-option CLTI diabetic patients, PB-MNCs therapy led to an improvement in tissue perfusion, a high rate of healing, and back-to-walk. Coupling circulating cellular markers of angiogenesis could help in the identification of patients with a better clinical benefit over time.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- 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
- Date Crossref
- 28/09/2022
- Éditeur
- Springer Science and Business Media LLC
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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MultiMedica pays non établi dans la noticeÉtablissement de santé
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Istituti di Ricovero e Cura a Carattere Scientifico pays non établi dans la noticeÉtablissement de santé
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Casa Sollievo della Sofferenza Unit of Endocrinology pays non établi dans la noticeÉtablissement de santé
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Fondazione IRCCS Istituto Nazionale dei Tumori pays non établi dans la noticeÉtablissement de santé
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University of Rome Tor Vergata Diabetic Foot Unit pays non établi dans la noticeUniversité ou école supérieure
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CTO Andrea Alesini pays non établi dans la noticeÉtablissement de santé
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University of Insubria Laboratory of Immunology and General Pathology pays non établi dans la noticeUniversité ou école supérieure
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Diabetic Foot Dpt pays non établi dans la noticeInstitution
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Value-based Healthcare Unit pays non établi dans la noticeInstitution
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Laboratory of Cardiovascular Pathophysiology-Regenerative Medicine pays non établi dans la noticeStructure de recherche
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Vascular Surgery Unit pays non établi dans la noticeInstitution
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Interventional Cardiology Unit pays non établi dans la noticeInstitution
MultiMedica, Istituti di Ricovero e Cura a Carattere Scientifico et Unit of Endocrinology — Casa Sollievo della Sofferenza, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.