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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Biological: ALLO-ASC-SHEET

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yun Jung Choi, PM; Phone Number: 82 10 9199 0164; Email: yunjungchoi@anterogen.com
• Study Contact Backup: Name: Jessi Choi, PM; Phone Number: 82 10 9199 0164

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • University of Southern California
      • Contact: David Armstrong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female between 18 and 80 years of age.
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:

1. Ulcer is of non-diabetic pathophysiology.
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Anterogen Co., Ltd.
• Investigators: Study Director: Yun Jung Choi, PM, Anterogen Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: ALLO-ASC-SHEET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No