Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers
NCT ID: NCT04497805
Last Updated: 2023-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
64 participants
INTERVENTIONAL
2020-09-08
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ALLO-ASC-SHEET
ALLO-ASC-SHEET Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells
ALLO-ASC-SHEET
Hydrogel sheet containing Allogenic Mesenchymal Stem Cells
Hydrogel SHEET(Vehicle control)
Vehicle Control Hydrogel sheet without allogenic adipose-derived mesenchymal stem cells
ALLO-ASC-SHEET
Hydrogel sheet containing Allogenic Mesenchymal Stem Cells
Interventions
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ALLO-ASC-SHEET
Hydrogel sheet containing Allogenic Mesenchymal Stem Cells
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Foot ulcer located in the plantar or dorsal, with ulcer size between1.5 cm2 and 15 cm2.
4. Ulcer, Graded II by Wagner grade, and extended to muscle periosteum, muscle, tendon, or joint capsule, but not to bone.
5. Ulcer is free of necrotic debris,exhibits no signs of clinical infection.
6. 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.
7. Is able to give written informed consent prior to study start and to comply with the study requirements.
Exclusion Criteria
2. The ulcer has increased or decreased in size by ≥30% during 2 weeks screening period.
3. 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.
4. The longest dimension of the index wound exceeds 15 cm at the baseline visit.
5. 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).
6. Current evidence of active charcot, osteomyelitis, cellulitis, or evidence of other infection including fever or purulentdrainage from wound site.
7. Is Human Immunodeficiency Virus (HIV) positive
8. Havesevere hepatic deficiencies.
9. Have a glycated hemoglobin A1c (HbA1c) level of \>10%.
10. Have an allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
11. Have severe renal function insufficiency documented with creatinine greater than 3.0 mg/dL.
12. Pregnant or breast-feeding.
13. Is unwilling to use an "effective" method of contraception during the study.
14. Have evidence of current infection including purulent drainage from the wound site.
15. Have a clinically relevant history of alcohol or drugs abuse.
16. Have postprandialblood sugar \>350 mg/dL at screening.
17. Is not able to comply with the study requirements.
18. Is considered by the Investigator to have a significant disease which might impact the study.
19. Is considered not suitable for the study by Investigator.
20. Have a history of malignancy within the last 5 years (except basal cell carcinoma in situ).
21. Is currently or were enrolled in another clinical study within 60 days of screening.
22. Have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
23. 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.
24. Cannot maintain off-loading process.
25. Panel reactive antibody (PRA) levels ≥ 20% at screening.
26. Venereal Disease Research Laboratory test (VDRL) or RPR positive
18 Years
80 Years
ALL
No
Sponsors
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Anterogen Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yun Jung Choi, PM
Role: STUDY_DIRECTOR
Anterogen Co., Ltd.
Locations
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University of Southern California
Los Angeles, California, United States
Countries
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Central Contacts
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Jessi Choi, PM
Role: CONTACT
Facility Contacts
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David Armstrong, MD
Role: primary
Other Identifiers
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ALLO-ASC-SHEET
Identifier Type: -
Identifier Source: org_study_id
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