Table 1 Inclusion and exclusion criteria

Adult male or female, 40 years of age or over (until 86 years old)

Participants that do not sign the informed consent

TcPO₂ ≤ 30 mmHg

Presence of osteomyelitis

Diagnosis of diabetes

Hemodynamic instability (MAP < 65 mmHg or vasopressor requirement)

Patients with signs of critical ischemia such as:

Any acute systemic infectious disease process

 Ulcer that does not heal

 Necrosis or loss of tissue

 Pain at rest

Intermittent claudication

Basal Rutherford classification stage 3 to 5

Severe sepsis

Non-revascularized patients due to comorbidities and/or anatomy

Uncontrolled coagulopathy

Patients that despite revascularization (vascular surgery) have adequate distal beds to perfuse the limb

Condition of cancer

Ankle/brachial index less than 0.4

Use of immunosuppressive or cytotoxic drugs

Stenosis or occlusion of the infrapatellar arteries

Alterations 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