The Use Of Selective Filtration Of Monocytes From Peripheral Blood In Patients With Vascular Ulcers Promotes Healing. A Pilot Study In A High Volume Vascular Surgery Centre

Introduction: Monocytes have a documented action to promote the healing of trophic lesions through the regenerative action of the transformation of M1 macrophages into M2 macrophages, with multilineage potential comparable to that of mesenchymal stem cells (MSC). Patients affected by peripheral artery disease in Rutherford 5 and 6 stage may be considered suitable. The monocytes can be harvested from peripheral venous blood and injected both in peri-arterial leg areas and in ulcerative lesions. Methods: From 2015 to 2018, 200 procedures were performed in our centre for obstructive arterial disease of the lower limbs, causing PAD. Twelve (12) patients were considered non-revascularisable (5.5%). This was a first therapeutic approach in 7/12 (58.3%), while it was proposed as a therapeutic alternative in patients already subjected to previous operations and / or revascularisation attempts in 5 (41.6%). Demographic and clinical features are collected. An informed consent was obtained in all patients. In 72.5% three or four cycles were performed. All patients followed post-operative medical therapies and adjuvant medications during the months following treatment. Results: Comorbidities included hypertension in 91%, CRC in 63%, dyslipidaemia in 90%, cardiopathy in 72%, COPD in 63%, diabetes in 20%, smoking in 55% (of which 50% ex-smokers) at median follow up of 18 months DS (+/- 7 months) the survival rate was 81.8% (ES 0,11) the limbs savage was 51.1% (ES 0,15). Amputation rate was respectively: minor 45.5% and major 9%. Considering minor amputation as a limb salvage, this percentage increased to 83.4%. Four deaths unrelated to therapy were observed. The pain with VAS score measurement varied from reduction in 36.3% to disappearance in 27.2%. Data regarding TCp02 has increased : a post-operative median level in the examined patients was 24.8 mmHg T2. Conclusion: The filtration procedure with mononuclear cells is safe and must be applied selectively. In high volume centres it is possible to evaluate candidate patients for this type of intervention. Additional procedures must be associated to complete the therapeutic procedure. Due to the increasing complexity and comorbidity of patients, careful selection is required; a multidisciplinary approach and accurate patient follow up is needed. Multicentre studies with multiple cases are needed to validate the Results.