Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic 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 Foot Ulcers, compared to placebo therapy.

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

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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Biological: ALLO-ASC-DFU
* Procedure: Hydrogel SHEET(Vehicle control)


Participation Criteria
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Eligibility Criteria
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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%

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALLO-ASC-DFU<br>Experimental: ALLO-ASC-DFU Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells | Biological: ALLO-ASC-DFU<br>* Application of ALLO-ASC-DFU Sheet to diabetic foot ulcer<br>* Other names: Hydrogel sheet containing Allogenic Mesenchymal Stem Cells;|
| Placebo Comparator: Hydrogel SHEET(Vehicle control)<br>Placebo Comparator: Vehicle Control Hydrogel sheet without allogenic adipose-derived mesenchymal stem cells | Procedure: Hydrogel SHEET(Vehicle control)<br>* Application of Hydrogel SHEET to diabetic foot ulcer<br>* Other names: Hydrogel sheet without 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 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to initial complete wound closure between the two groups | Time to initial complete wound closure between the two groups | During 12 weeks | 
| Changes in wound size compared to baseline between the two 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 by the classification of location of diabetic foot ulcer, Plantar and the other location between the two groups | Proportions of subjects who achieved complete wound closure | During 12 weeks(at every visit during treatment period) | 
| Durability of complete wound closure | Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices) | Follow up to 24 weeks from the initial complete wound closure. |