Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers

Study Overview
=================
Brief Summary
-----------------
This is a phase II single-blinded study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to standard therapy.

Detailed Description
-----------------
ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a Diabetic Foot Ulcer.

Official Title
-----------------
Phase 2 Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers: A Randomized, Comparator-controlled, Single-blind, Parallel-group, Multi-center Study

Conditions
-----------------
Diabetic Foot Ulcer

Intervention / Treatment
-----------------
* Biological: ALLO-ASC-DFU
* Other: Standard therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is between 18 years and 80 years of age. Subject is diagnosed with Type I or Type II diabetes, and had defined as diabetic foot ulcers presence of wound for more than 4 weeks at the screening visit. Ulcer located the foot, and ulcer size is between 1 cm^2 and 25 cm^2. Ulcer extends into the dermis, subcutaneous tissue, tendon or joint capsule (Wagner grade 1 or 2). Ulcer is free of necrotic debris. Subjects had adequate circulation to ulcer as documented by one of the methods below: Palpation of pulses around ulcer using Doppler exam Ankle Brachial index (ABI) values ranging between 0.7 and 1.3, or Transcutaneous Oxygen Pressure (TcPO2) > 30 mmHg. Subject 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% or more during one week after the screening visit. Subject is Human Immunodeficiency Virus (HIV) positive. Subjects with severe hepatic deficiencies. Subjects with a glycated hemoglobin A1c (HbA1c) level of > 15%. Subject who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue. Subjects requiring intravenous (IV) antibiotics to treat the index wound infection. Subjects with severe renal deficiencies that is uncontrolled by dialysis Subjects who are pregnant or breast-feeding. Subjects who are unwilling to use an effective method of contraception during the study. Current evidence of severe infection including pus drainage from the wound site. Subjects who have a clinically relevant history of alcohol or drugs abuse. Subject's blood sugar is > 450 mg/dL at postprandial. Subjects who are not able to understand the objective of this study or to comply with the study requirements. Subjects who are considered to have a significant disease which can impact the study by the investigator. Subjects who are considered not suitable for the study by the investigator. Subjects who have a history of surgery for malignant tumor within the last five years (except carcinoma in situ). Subjects who are currently or were enrolled in another clinical study within 60 days of screening. Subjects who have undergone wound treatments with cell therapy, dermal substitutes, or other biological therapies within the last 30 days. Subjects who are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents to unstable dosage.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALLO-ASC-DFU<br>Allogeneic mesenchymal stem cells | Biological: ALLO-ASC-DFU<br>* Application of ALLO-ASC-DFU sheet to diabetic foot ulcer<br>* Other names: Allogeneic mesenchymal stem cells;|
| Active Comparator: Standard therapy<br>Standard therapy for patients with diabetic foot ulcer | Other: Standard therapy<br>* Standard therapy conducted for patients with diabetic foot ulcer<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of re-epithelialization |  | During 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of re-epithelialization |  | During 12 weeks | 
| Time to re-epithelialization |  | During 12 weeks | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | Follow up to 12 weeks |