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

Study Overview
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Brief Summary
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This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Wagner Grade II Foot Ulcers, compared to placebo therapy.

Official Title
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A Phase 2 Clinical Study to Evaluate The Efficacy and Safety of ALLO-ASC-SHEET in the Subjects With Diabetic Wagner Grade II Foot Ulcers

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Biological: ALLO-ASC-SHEET


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female between 18 and 80 years of age. Diagnosed with Type I or Type II diabetes and has Wagner Grade II diabetic foot ulcers for longer than 4 weeks at the time of screening. Foot ulcer located in the plantar or dorsal, with ulcer size between1.5 cm2 and 15 cm2. Ulcer, Graded II by Wagner grade, and extended to muscle periosteum, muscle, tendon, or joint capsule, but not to bone. Ulcer is free of necrotic debris,exhibits no signs of clinical infection. Ulcer area blood circulation meets 1 of the following criteria: A. Blood vessels around the ulcer detected by Doppler Test to have biphasic or triphasic flow B. Range of Ankle Brachial Index(ABI) is>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 2 weeks screening period. 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. The longest dimension of the index wound exceeds 15 cm at the baseline visit. 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). Current evidence of active charcot, osteomyelitis, cellulitis, or evidence of other infection including fever or purulentdrainage from wound site. Is Human Immunodeficiency Virus (HIV) positive Havesevere hepatic deficiencies. Have a glycated hemoglobin A1c (HbA1c) level of >10%. Have an allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue. Have severe renal function insufficiency documented with creatinine greater than 3.0 mg/dL. Pregnant or breast-feeding. Is unwilling to use an effective method of contraception during the study. Have evidence of current infection including purulent drainage from the wound site. Have a clinically relevant history of alcohol or drugs abuse. Have postprandialblood sugar >350 mg/dL at screening. Is not able to comply with the study requirements. Is considered by the Investigator to have a significant disease which might impact the study. Is considered not suitable for the study by Investigator. Have a history of malignancy within the last 5 years (except basal cell carcinoma 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 (In doses greater than 10 mg per day), any immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening. Cannot maintain off-loading process. Panel reactive antibody (PRA) levels ≥ 20% at screening. Venereal Disease Research Laboratory test (VDRL) or RPR positive

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALLO-ASC-SHEET<br>ALLO-ASC-SHEET Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells | Biological: ALLO-ASC-SHEET<br>* Hydrogel sheet containing Allogenic Mesenchymal Stem Cells<br>* Other names: Hydrogel sheet containing Allogenic Mesenchymal Stem Cells;|
| Placebo Comparator: Hydrogel SHEET(Vehicle control)<br>Vehicle Control Hydrogel sheet without allogenic adipose-derived mesenchymal stem cells | Biological: ALLO-ASC-SHEET<br>* Hydrogel sheet containing Allogenic Mesenchymal Stem Cells<br>* Other names: Hydrogel sheet containing Allogenic Mesenchymal Stem Cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportions of subjects who achieved complete wound closure. | Proportions of subjects who achieved complete wound closure during the 12 weeks. | During 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to initial complete wound closure between the 2 groups. | Measure the time to initial complete wound closure between the 2 groups. | During 12 weeks | 
| Changes in wound size compared to baseline between the 2 groups. | Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices). | During 12 weeks | 
| Proportions of subjects who achieved complete wound closure between the 2 groups by the classification of wound size. | Proportions of subjects who achieved complete wound closure by the classification of wound size, 1.5 7 cm2 and 7.1 15 cm2 between the 2 groups at every visit. | During 12 weeks | 
| Proportions of subjects who achieved complete wound closure between the 2 groups by the classification of location of diabetic foot ulcer. | Proportions of subjects who achieved complete wound closure by the classification of location of diabetic foot ulcer, plantar and dorsal between the 2 groups at every visit by post-hoc analysis. | During 12 weeks | 
| Durability of complete wound closure for the additional 24 weeks. | Durability of complete wound closure for the additional 24 weeks from the initial complete wound closure. Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices). | During 36 weeks |