Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Wagner Grade 2 Foot Ulcers.

Phase 3 Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Wagner Grade 2 Foot Ulcers: A Randomized, Comparator-controlled, Double-blind, Parallel-group, Multi-center Study

This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Wagner grade 2 Foot Ulcer, compared to placebo therapy.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Biological: ALLO-ASC-DFU; Procedure: Vehicle Sheet

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 Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: SeungKyu Han, MD. Ph D; Phone Number: +82-02-2626-3333; Email: pshan@kumc.or.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 08308
    • Recruiting
    • Korea University Guro Hospital
    • Contact: SeungKyu Han, MD. Ph D.; Phone Number: +82-02-2626-3333; Email: pshan@kumc.or.kr
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Asan Medical Center
    • Contact: JunPio Hong, MD. Ph D; Email: joonphong@amc.seoul.kr
  • Seoul, Korea, Republic of, 07061
    • Recruiting
    • Borame Medical Center
    • Contact: JiUng Bak, MD. Ph D; Phone Number: +82-02-870-2332; Email: alfbskan@gmail.com
  • Bucheon
    • Gyeonggi-do, Bucheon, Korea, Republic of, 14647
      • Recruiting
      • Bucheon St. Mary's Hospital
      • Contact: YeongCheol Seo, MD. Ph D; Email: ycsuh@catholic.ac.kr
  • Seongnam-si
    • Gyeonggi-do, Seongnam-si, Korea, Republic of, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: BaekKyu Kim, MD. Ph D; Phone Number: +82-031-787-7224; Email: 65683@snubh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject is between 19 and 75 years of age.
2. Subject is diagnosed with Type I or Type II diabetics.
3. Diabetic foot ulcer has been more than 4 weeks but less than 52 weeks at the screening visit.
4. Ulcer located in the foot and ulcer size is between 1.5~15 cm2.
5. Ulcer graded 2 by Wagner grade.
6. Foot ulcer extended to ligament, tendon, joint capsule, fascia, muscle and periosteum.
7. Ulcer is free of necrotic debris.

8. Ulcer area blood circulation meets one of the following criteria;

   • Blood vessels around the ulcer detected by Doppler Test
   • Range of Ankle Brachial Index (ABI) is > 0.7 to < 1.3
   • Transcutaneous Oxygen Pressure (TcPO2) > 30mmHg or Toe Blood Pressure (TBP) > 40mmHg.
   • Skin Perfusion Pressure (SPP) > 30mmHg
9. Subject is able to give written informed consent prior to study start and willing to comply with the study requirements.

Exclusion Criteria:

1. Ulcer is of non-diabetic pathophysiology.
2. There is gangrene in any part of the target foot ulcer.
3. The longest dimension of the target foot ulcer exceeds 15 cm at the enrollment visit.
4. Other wounds within 2cm of the target foot ulcer.
5. The ulcer has increased or decreased in size by ≥ 30% during two weeks after the screening visit.
6. Patient requiring intravenous (IV) antibiotics to treat foot wound infection at the screening and enrollment visit.
7. Current evidence of active charcot on the study foot, osteomyelitis, cellulitis, or evidence of other infection including fever or purulent drainage from wound site.
8. 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.
9. An active malignant tumor(malignant melanoma, squamous cell carcinoma, basal cell carcinoma) on the body or skin.
10. Have a glycated hemoglobin A1c (HbA1c) level of > 14%
11. Have random blood sugar > 450mg/dL
12. Have severe renal failure with creatinine > 3.0mg/dL.

13. Have severe hepatic deficiencies

    • Total bilirubin ≥ 1.5×upper normal limit(UNL)
    • AST, ALT ≥ 2.0×UNL
    • Serum albumin < 2.0mg/dL
14. Is Human Immunodeficiency Virus (HIV) positive
15. Have a known history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue
16. Pregnant or breast-feeding.
17. Is unwilling to use an acceptable method of birth control during the whole study.
18. Have a clinically relevant history of alcohol or drugs abuse at the screening visit.
19. Is not able to understand the objective of the study or to comply with the study requirements
20. Is considered by the Investigator to have a significant disease which might impact the study
21. Is considered not suitable for the study by Investigator
22. Have a history of malignancy within the last 5 years (except carcinoma in situ)
23. Is currently or were enrolled in another clinical study within 60 days of screening
24. Have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
25. Is receiving oral or parenteral corticosteroids, any immunosuppressive, or cytotoxic agents with unstable dose within the last 30 days
26. Cannot maintain off-loading process and device.

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; Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells	Biological: ALLO-ASC-DFU; Application of ALLO-ASC-DFU sheet to Diabetic Wagner grade 2 Foot Ulcer
Placebo Comparator: Vehicle sheet; Hydrogel sheet without allogenic mesenchymal stem cell	Procedure: Vehicle Sheet; Application of Vehicle sheet to Diabetic Wagner grade 2 Foot Ulcer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportions of subjects who achieved complete wound closure	During 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Time taken to complete wound closure	During 12 weeks
Proportions of subjects who achieved complete wound closure at every visit	During 12 weeks
Change rates in wound size and depth compared to baseline groups	During 12 weeks

Collaborators and Investigators

• Sponsor: Anterogen Co., Ltd.
• Investigators: Principal Investigator: SeungKyu Han, MD. Ph D, Korea University Guro Hospital; Principal Investigator: BaekKyu Kim, MD. Ph D, Seoul National University Bundang Hospital; Principal Investigator: JunPio Hong, MD. Ph D, Asan Medical Center; Principal Investigator: JiUng Bak, MD. Ph D, Borame Medical Center; Principal Investigator: YeongCheol Seo, MD. Ph D, Bucheon St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 24, 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-DFU-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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