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

A Phase 2 Clinical Study to Evaluate the Efficacy and Safety of ALLO-ASC-SHEET in Subjects With Diabetic 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 Foot Ulcers, compared to placebo therapy.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Biological: ALLO-ASC-DFU; Procedure: Hydrogel SHEET(Vehicle control)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: David G. Armstrong, MD.Ph D.; Phone Number: (+1)5203059393; Email: armstrong@usa.net

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90089
      • University of Southern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female subjects between 18 and 80 years of age.
2. Diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit.
3. Foot ulcer located in the instep, border or sole of the foot, with ulcer size between 1 cm2 and 15 cm2.
4. Ulcer graded I by Wagner grade, and extended to skin, subcutaneous tissue, but without exposure of muscle, tendon, bone or joint capsule.
5. Ulcer is free of necrotic debris, exhibits no signs of clinical infection.

6. 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.
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 the week after the Screening Visit.
3. Is Human Immunodeficiency Virus (HIV) positive?
4. Have severe hepatic deficiencies.
5. Have a glycated hemoglobin A1c (HbA1c) level of > 10%.
6. Have allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
7. Require intravenous (IV) antibiotics to treat the target wound infection.
8. Have severe renal failure including subject on renal dialysis.
9. Pregnant or breast-feeding.
10. Is unwilling to use an "effective" method of contraception during the study.
11. Have evidence of current infection including pus drainage from the wound site.
12. Have a clinically relevant history of alcohol or drugs abuse.
13. Have postprandial blood sugar > 350 mg/dl.
14. Is not able to understand the objective of this study or to comply with the study requirements.
15. Is considered by the investigator to have a significant disease which might have impacted the study.
16. Is considered not suitable for the study by investigator.
17. Have a history of malignancy within the last five years (except basal cell carcinoam in situ).
18. Is currently or were enrolled in another clinical study within 60 days of screening.
19. Have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
20. Is receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening.
21. Cannot maintain off-loading process
22. Panel reactive antibody (PRA) levels ≥ 20%

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALLO-ASC-DFU; 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: Hydrogel sheet containing Allogenic Mesenchymal Stem Cells
Placebo Comparator: Hydrogel SHEET(Vehicle control); Placebo Comparator: Vehicle Control Hydrogel sheet without allogenic adipose-derived mesenchymal stem cells	Procedure: Hydrogel SHEET(Vehicle control); Application of Hydrogel SHEET to diabetic foot ulcer; Other Names: Hydrogel sheet without 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 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.

Collaborators and Investigators

• Sponsor: Anterogen Co., Ltd.
• Investigators: Principal Investigator: David G. Armstrong, MD.Ph D., University of Southern California; Principal Investigator: Alexander M. Reyzelman, DPM, Center for Clinical Research; Principal Investigator: Young Nathan, DPM, Martinsville Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2019
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: November 25, 2018
• First Posted (Actual): November 27, 2018

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-102

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