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

ABSTRACT Background 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 critical limb-threatening ischemia (CLTI) from atherosclerotic lower extremity artery disease (LEAD). However, uncertain clinical prognostic factors impact treatment outcomes. Methods In this retrospective, single-center, observational study, we assessed the long-term prognosis post-treatment. Primary endpoints included the long-term prognosis of BM-MNC implantation and factors influencing 1-year outcomes. Results A total of 92 limbs in 84 patients were analyzed in the final cohort. The mean age was 67 years, and 65% were male. 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 an age ≥70 years, hemodialysis, smoking, and a controlling nutrition status score ≥5. Major amputation or mortality was associated with male gender, hemodialysis, and C-reactive protein levels ≥3.0 mg/dL. No adverse events were associated with therapeutic angiogenesis. Conclusions 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. Clinical Perspective What is new? This study shows a new scoring model of therapeutic angiogenesis using autologous bone marrow-derived mononuclear cell implantation in patients or their limbs with no-option chronic limb-threatening ischemia (CLTI) attributed to atherosclerotic lower extremity artery disease (LEAD). High age, hemodialysis, smoking, malnutrition, ambulatory, and inflammatory response are identified as prognostic factors. A scoring formula, developed through these factors, effectively identifies a group with a favorable long-term prognosis in both patients and limbs. The counts of bone marrow-derived mononuclear cells and CD34 surface antigen-positive cells are found to have a significant relationship with a 1-year prognosis in both patients and limbs. What are the clinical implications? This study demonstrates the feasibility and safety of bone marrow-derived mononuclear cell implantation among patients with no-option CLTI patients resulting from LEAD. This scoring model will help us predict the long-term prognosis of patients and their affected limbs treated by bone marrow-derived mononuclear cell implantation. These results also provide valuable information for choosing a personalized treatment plan for each patient.