Peripheral Blood Mononuclear Cells Therapy for Treatment of Lower Limb Ischemia in Diabetic Patients: A Single-Center Experience

Background: The aim of this study is to analyze the effects of peripheral blood mononuclear cells (PBMNCs) therapy in diabetic patients with critical limb ischemia (CLI), with particular regard to its application, as adjuvant therapy in patients underwent endovascular revascularization. Methods: Fifty diabetic patients affected by CLI were enrolled. All patients underwent PBMNCs therapy. Thirty-two patients underwent PBMNCs therapy associated with endovascular revascularization (adjuvant therapy group). In 18 patients, who were considered nonrevascularizable or underwent unsuccessful revascularization, regenerative therapy with PBMNCs was performed as the therapeutic choice (PBMNCs therapy group). Results: The median follow-up period was 10 months. The baseline and end point results in adjuvant group were as follows. The mean transcutaneous partial pressure of oxygen (TcPO2) improved from 25 ± 9.2 mmHg to 45.6 ± 19.1 mmHg (P < 0.001), and visual analogue scale (VAS) score means decreased from 8.6 ± 2.1 to 3.8 ± 3.5 (P = 0.001). In PBMNCs therapy group, the mean TcPO2improved from 16.2 ± 7.2 mmHg to 23.5 ± 8.4 mmHg (P < 0.001), and VAS score means decreased from 9 ± 1.1 to 4.1 ± 3.3 (P = 0.001). Major amputation was observed in 3 cases (9.4%), both in adjuvant therapy group and in PBMNCs therapy one (16.7%) (P = 0.6). Conclusions: The role of cellular therapy with PBMNCs is decisive in the patients that are not susceptible to revascularization. In diabetic patients with CLI and healing resistant ulcers, the adjuvant PBMNCs therapy could represent a valid therapeutic option.