Clinical Study of ALLO-ASC-SHEET in Subjects with Diabetic Foot Ulcers

• Active Group: ALLO-ASC-SHEET
• Control Group: Hydrogel SHEET (vehicle control)
• Study Type: Interventional
• Study Design: Randomized, Comparator-controlled, Double-blind, multi-center study.

Inclusion criteria

• Male or female subjects between 18 and 80 years of age.
• Diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit.
• Foot ulcer located in the instep, border or sole of the foot, with ulcer size between 1 cm2 and 15 cm2.
• Ulcer graded I by Wagner grade, and extended to skin, subcutaneous tissue, but without exposure of muscle, tendon, bone or joint capsule.
• Ulcer is free of necrotic debris, exhibits no signs of clinical infection.
• Ulcer area blood circulation meets one of the following criteria

• A. Blood vessels around the ulcer detected by Doppler Test
• B. range of Ankle Brachial Index(ABI) was > 0.7 to < 1.3
• C. Transcutaneous oxygen pressure, (TcPO2) > 30 mmHg.
• Is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion criteria

• Ulcer is of non-diabetic pathophysiology.
• The ulcer has increased or decreased in size by ≥ 30% during the week after the Screening Visit.
• Is Human Immunodeficiency Virus (HIV) positive?
• Have severe hepatic deficiencies.
• Have a glycated hemoglobin A1c (HbA1c) level of > 10%.
• Have allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
• Require intravenous (IV) antibiotics to treat the target wound infection.
• Have severe renal failure including subject on renal dialysis.
• Pregnant or breast-feeding.
• Is unwilling to use an "effective" method of contraception during the study.
• Have evidence of current infection including pus drainage from the wound site.
• Have a clinically relevant history of alcohol or drugs abuse.
• Have postprandial blood sugar > 350 mg/dl.
• Is not able to understand the objective of this study or to comply with the study requirements.
• Is considered by the investigator to have a significant disease which might have impacted the study.
• Is considered not suitable for the study by investigator.
• Have a history of malignancy within the last five years (except basal cell carcinoam in situ).
• Is currently or were enrolled in another clinical study within 60 days of screening.
• Have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
• Is receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening.
• Cannot maintain off-loading process
• Panel reactive antibody (PRA) levels ≥ 20%