Application of Cell Regeneration Therapy With Mesenchymal Stem Cells From Adipose Tissue in Critical Chronic Ischemic Syndrome of Lower Limbs (CLI) in Nondiabetic Patients.

This is an interventional treatment trial for Critical Limb Ischemia Read More

Inclusion Criteria:

• Patients of both sexes aged ≥ 18 and ≤ 89 years.
• Nondiabetic.
• Infrapopliteal atherosclerotic vascular disease of severe grade with either severe claudication or Rutherford-Becker grade II-III-IV, of at least one lower limb. It is defined critical ischemia of the lower limb as persistent/recurrent pain requiring analgesia and / or non-healing present ulcers > 4 weeks, with no evidence of improvement with conventional therapies and / or walking test (stress test) between 1-6 minutes in two exercise tests separated by at least 2 weeks and / or ankle-brachial index at rest <0.8.
• Inability of surgical or endovascular revascularization as recommended by the TransAtlantic InterSociety Consensus (TASC).
• Failure in the revascularization surgery performed at least 30 days before, with persistence or entry in critical ischemia phase.
• Life expectancy> 2 years.
• Not expected major amputation in the limb to treat in the next 12 months after inclusion.

• Normal biochemical parameters defined by:

  1. Leukocytes ≥ 3000
  2. Neutrophils ≥ 1500
  3. Platelets ≥ 100,000
  4. Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) ≤ 2.5 standard range institution
  5. Creatinine ≤ 2.5 mg / dl.
• Patients give their written informed consent to participate in the study.
• Women of childbearing potential must have negative results on a pregnancy test done at the time of inclusion in the study and agree to use a medically approved method of contraception for the duration of the study.

Exclusion Criteria:

• History of malignancy or hematologic disease (myeloproliferative disease, myelodysplastic syndrome or leukemia) in the last two years.
• Patients with uncontrolled hypertension (defined as blood pressure> 180/110 on more than one occasion).
• Severe heart failure (New York Heart Association class IV) or ejection fraction of the left ventricle less than 30%.
• Patients with malignant ventricular arrhythmias or unstable angina at the time of infusion.
• Diagnosis of deep vein thrombosis in the previous 3 months.
• Active infection or wet gangrene at day of infusion of Mesenchymal Stem Cells from Adipose Tissue.
• Concomitant therapy including hyperbaric oxygen. It is allowed the use of antiplatelet agents.
• Body mass index>40 kg/m2.
• Patients with a diagnosis of alcoholism at the time of inclusion.
• Untreated proliferative retinopathy.
• Concomitant disease that reduces life expectancy to less than a year.
• Predicted impossibility to obtain a biopsy providing 10 g of adipose tissue.
• human immunodeficiency virus, hepatitis B virus or hepatitis C virus.
• Difficulty in monitoring.
• Stroke or myocardial infarction within the last 3 months.
• Anemia (hemoglobin <7.9 mg / dl).
• Leukopenia.
• Thrombocytopenia (<100,000 platelets / ul).
• Pregnant women or women of childbearing age who do not have adequate contraception.
• Patients who participated in a clinical trial within the last 3 months prior to inclusion in this clinical trial.