Bone Marrow Mononuclear Cells vs Mesenchymal Stem Cells in Diabetic Patients With Chronic Limb Ischemia

Patients in the severe stages of Chronic limb-threatening ischemia (CLTI) are prone to amputation and death, leading to poor quality of life and a great socioeconomic burden.There is an urgent need to develop an effective therapeutic strategy to treat this disease. In this context, autologous bone marrow mononuclear cells (BM-MNC) and allogeneic mesenchymal stem cells derived from different sources have emerged as promising therapeutic approaches for this condition.

Inclusion Criteria:Adult male or female, 40 years of age or over (until 85 years old)TcPO2 ≤ 30 mmHg.Diagnosis of diabetes.Patients with signs of critical ischemia such as (i) ulcer that does not heal, (ii) necrosis or loss of tissue, (iii) pain at rest, and (iv) intermittent claudication.Basal Rutherford classification stage 3 to 5.Non-revascularizable patients due to comorbidities and/or anatomy.Patients that despite revascularization (vascular surgery), have adequate distal beds to perfuse the limb.Ankle/brachial index less than 0.4.Stenosis or occlusion of the infrapatellar arteries.Exclusion Criteria:Participants that do not sign the informed consent.Presence of osteomyelitis.Hemodynamic instability (MAP<65 mmHg or vasopressor requirement).Any acute systemic infectious disease process.Severe sepsis.Uncontrolled coagulopathy.Condition of cancer.Use of immunosuppressive or cytotoxic drugsAlterations of the bone marrow that do not allow the adequate extraction of the components to be used as: acute leukemia, chronic leukemia, marrow aplasia, myelodysplastic syndrome, and myelophthisis.Contraindication of sedation for bone marrow aspirate.Patients who have suffered in a period < six months of myocardial infarction, disease cerebrovascular or coronary intervention.Patients with liver failure indicated by serum transaminases (aspartate aminotransferase and alanine aminotransferase), with values twice the normal limit.Any acute or chronic contagious disease including hepatitis B, hepatitis C, and HIV.Any other comorbidity that the treating vascular surgeon considers as a contraindication to cell treatments.