Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine

Safety of Autologous Adipose Derived Stroma/Stem Cells to Treat Critical Leg Ischemia.

The main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with expanded adipose derived stroma/stem cells sue, administered intramuscularly in patients with critical leg ischemia.

Inclusion Criteria:

• Severe peripheral vascular disease not amenable to bypass or angioplasty
• Age >40 years old
• Normal renal function (creatinine < 1.6)
• Non pregnant female
• Lifespan > 6 months

Exclusion Criteria:

• Age <40 years old
• Refusal to give informed consent and/orCognitively disabled
• Congestive heart failure or stroke in the last 3 months
• History of cancer or myeloproliferative disorders
• Proliferative retinopathy
• Pregnancy
• Positive screening test for HIV, Hepatitis B or Hepatitis C
• Buerger patient
• Cachexia or predicted impossibility for a biopsy of at least 30 grams of fat tissue
• Pregnancy or lactation
• Having been non controlled severe pathology