Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers.
Study Details
Study Description
Brief Summary
This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to placebo therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Experimental: ALLO-ASC-DFU, Placebo Comparator: Vehicle Sheet, Study type: Interventional, Study design: Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center Study
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ALLO-ASC-DFU Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells |
Biological: ALLO-ASC-DFU
Application of ALLO-ASC-DFU sheet to diabetic foot ulcer
Other Names:
|
| Placebo Comparator: Vehicle Sheet Hydrogel sheet without Allogenic mesenchymal stem cell |
Procedure: Vehicle sheet
Application of Vehicle sheet to diabetic foot ulcer
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Proportions of subjects who achieved complete wound closure [During 12 weeks]
Secondary Outcome Measures
- Time taken to complete wound closure between the two groups [During 12 weeks]
- Proportions of subjects who achieved complete wound closure [Follow up to 12 weeks]
- Proportions of subjects who achieved complete wound closure by the classification of Wagner Grade between the two groups [Follow up to 12 weeks]
- Change rates in wound size and depth compared to baseline between the two groups [During 12 weeks]
cm^2
- Proportions of subjects who achieved complete wound closure at every visit by the classification of ulcer locations [Follow up to 12 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject is between 18 and 75 years of age.
-
Subject is diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit.
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Foot ulcer size is between 1 cm2 and 15 cm2
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Ulcer graded I or II by Wagner grade, and extended to skin, tendon, and subcutaneous tissue.
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Free of necrotic debris at target ulcer
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Around ulcer area blood circulation should be secured to meet one of below criteria;
-
Blood vessels around the ulcer detected by Doppler Test
-
0.7 < Ankle Brachial Index(ABI) < 1.3
-
Transcutaneous Oxygen Pressure, TcPO2 higher than 30 mmHg
- Subject is able to give written informed consent prior to study start and to comply with the study requirements during study.
Exclusion Criteria:
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Non-diabetic pathophysiologic ulcer.
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The ulcer has increased or decreased in size by 30% or more during one week after the screening visit.
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Subjects requiring intravenous (IV) antibiotics to treat infection.
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Current evidence of infection including pus drainage from the wound site.
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Subject has a glycated hemoglobin A1c (HbA1c) level of > 15%
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Subject's blood sugar is > 450 mg/dl at postprandial.
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Subjects with severe renal failure that cannot be managed by renal dialysis.
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Subjects with severe hepatic deficiencies.
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Subject is Human Immunodeficiency Virus (HIV) positive.
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Subject who has allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
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Subject who is pregnant or breast-feeding.
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Subjects who are unwilling to use an "effective" method of contraception during the study.
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Subjects who have a clinically relevant history of alcohol or drugs abuse.
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Subjects who are not able to understand the objective of this study or to comply with the study requirements.
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Subjects who are considered to have a significant disease which can impact the study by investigator.
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Subjects who are considered not suitable for the study by investigator.
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Subjects who had had a history of surgery for malignant tumor within the last five years (except carcinoma in situ).
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Subjects who are currently or are enrolled in another clinical study within 60 days of screening.
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Subjects who have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
-
Subjects who are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening.
-
Subjects not comply with off-loading procedure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Korea University Kuro Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Anterogen Co., Ltd.
Investigators
- Principal Investigator: Seung-Kyu Han, MD. Ph D., Korea University Guro Hospital
- Principal Investigator: Ki-Won Young, MD. Ph D., Eulji General Hospital
- Principal Investigator: Junpyo Hong, MD. Ph D., Asan Medical Center
- Principal Investigator: Donghyeok Shin, MD. Ph D., Konkuk University Medical Center
- Principal Investigator: Junhyeong Kim, MD. Ph D., Keimyung University Dongsan Medical Center
- Principal Investigator: Kang Chan, MD. Ph D., Chungnam National University Hospital
- Principal Investigator: Hyungmin Hahn, MD. Ph D., Ajou University Medical Center
- Principal Investigator: Changsik Park, MD. Ph D., Seoul National University Bundang Hospital
- Principal Investigator: Youngkoo Lee, MD. Ph D., Soonchunhyang University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ALLO-ASC-DFU-301