Prognostic Factors After Bone Marrow-Derived Mononuclear Cell Implantation in No-Option Chronic Limb-Threatening Ischemia Patients with Atherosclerotic Lower Extremity Artery Disease.

Abstract

Previous studies have reported the efficacy and safety of therapeutic angiogenesis through bone marrow-derived mononuclear cell (BM-MNC) implantation in patients with no-option chronic limb-threatening ischemia (CLTI) from atherosclerotic lower extremity artery disease (LEAD). However, uncertain clinical prognostic factors impact treatment outcomes. This study aimed to elucidate the long-term outcomes of patients with atherosclerotic LEAD-derived no-option CLTI after BM-MNC implantation and to identify prognostic factors.In this retrospective, single-center, observational study, the primary endpoints included the long-term prognosis of BM-MNC implantation and factors influencing 1-year outcomes. A total of 92 limbs in 84 patients were analyzed in the final cohort (mean age: 67 years; male, 65%). The 5- and 10-year overall survival rates were 50.0% and 31.0%, respectively, while the 5- and 10-year amputation-free survival rates were 37.6% and 23.3%, respectively. Multivariate logistic analysis linked all-cause mortality to age ≥ 70 years, hemodialysis, smoking, and a controlling nutrition status score ≥ 5. Major amputation or mortality was associated with male sex, hemodialysis, and C-reactive protein levels ≥ 3.0 mg/dL. No adverse events were associated with therapeutic angiogenesis.These findings endorse the feasibility and safety of BM-MNC implantation for patients with no-option CLTI due to atherosclerotic LEAD. Moreover, the study highlights the significance of several prognostic factors, including advanced age, hemodialysis, smoking, and inflammatory markers, in influencing the long-term outcomes of this treatment.