Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers

Exclusion Criteria

• •1. Ulcer is of non-diabetic pathophysiology.
• •2. The ulcer has increased or decreased in size by ≥30% during 2 weeks screening period.
• •3. Patient is currently on higher dose antibiotic therapy as defined by increased dose or change in therapy from the initial treatment regimen at screening to treat index wound infection or patient is on suppressive antibiotic therapy for diabetic foot wound infection.
• •4. The longest dimension of the index wound exceeds 15 cm at the baseline visit.
• •5. Patient with skin lesion confirmed by biopsy (when Investigator deems suspicious) and then judged by Investigator to be an etiology other than diabetic foot ulcer (i.e.,example skin cancer in situ, pyoderma).
• •6. Current evidence of active charcot, osteomyelitis, cellulitis, or evidence of other infection including fever or purulentdrainage from wound site.
• •7. Is Human Immunodeficiency Virus (HIV) positive
• •8. Havesevere hepatic deficiencies.
• •9. Have a glycated hemoglobin A1c (HbA1c) level of \>10%.
• •10. Have an allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
• •11. Have severe renal function insufficiency documented with creatinine greater than 3.0 mg/dL.
• •12. Pregnant or breast-feeding.
• •13. Is unwilling to use an "effective" method of contraception during the study.
• •14. Have evidence of current infection including purulent drainage from the wound site.
• •15. Have a clinically relevant history of alcohol or drugs abuse.
• •16. Have postprandialblood sugar \>350 mg/dL at screening.
• •17. Is not able to comply with the study requirements.
• •18. Is considered by the Investigator to have a significant disease which might impact the study.
• •19. Is considered not suitable for the study by Investigator.
• •20. Have a history of malignancy within the last 5 years (except basal cell carcinoma in situ).
• •21. Is currently or were enrolled in another clinical study within 60 days of screening.
• •22. Have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
• •23. Is receiving oral or parenteral corticosteroids (In doses greater than 10 mg per day), any immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening.
• •24. Cannot maintain off-loading process.
• •25. Panel reactive antibody (PRA) levels ≥ 20% at screening.
• •26. Venereal Disease Research Laboratory test (VDRL) or RPR positive