Table 2 Eligibility criteria for patients enrolled in the study

Written informed consent

Patients with CLI suitable for surgical or percutaneous revascularization

Male or female, age between 18 and 85 years

Patients with any acute/chronic inflammatory condition

Severe PAD (Rutherford class II-4, III-5, or III-6)

Major tissue loss in either leg or potential need for major amputation or revascularization within one month of study entry

Resting pain or ischemic ulcer/necrosis/gangrene

Severe heart failure, respiratory failure, liver failure, kidney failure, or poor general condition so that the patient cannot tolerate stem cell transplantation

None surgical nor endovascular option

Diabetes mellitus with HbA1c > 7%

Active malignancy or history of malignancy within five years prior to study entry

Evidence of active infection

Stroke or acute myocardial infarction

Chronic kidney disease (Stage 4 and 5)

Any condition that leads to the patient not being able to express pain and complain about the disease (such as mental retardation, alcohol consumption)