Safety of Adipose-Derived Stem Cell Stromal Vascular Fraction

Exclusion Criteria

• •1. The subject is a woman of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year as documented in medical history), but is not using a highly effective method of contraception \[oral, injected or implanted hormonal methods of contraception; intrauterine device (IUD) or intrauterine system (IUS); condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; or male sterilization (vasectomy)\].
• •2. Subject has a history of cancer and/or any known conditions/diseases prone to malignancy.
• •3. Subject has significant cardiac, renal, or hepatic failure or any other disease that may interfere with the ability to interpret the results of the study.
• •4. Subject has an infection, cellulitis, or osteomyelitis diagnosed by MRI and microbiologic culture results.
• •5. Subject has an autoimmune disorder.
• •6. Subject has a connective, metabolic or atrophic skin disease.
• •7. Subject is under chronic anticoagulant therapy.
• •8. Subject has a Body Mass Index (BMI) \>30.
• •9. Subject is positive for HBs antigen, HCV antibody, or HIV antibody.
• •10. Subject has received other investigational drug/drugs or unapproved medication within 3 months before registration in this study.
• •11. Subject has a history of hematopoietic stem cell transplantation or radio immunotherapy.
• •12. Subject has a recent and significant weight loss, the cause of which has not been determined.
• •13. Subject has a history of hereditary linked malignancy in a first-degree relative (parent, child, sibling).
• •14. Subject is participating in another clinical trial within 6 weeks prior to registration in this study.
• •15. Subject has a psychiatric disorder that in the judgment of the investigator could interfere with provision of informed consent, completion of tests, therapy, or follow-up.