A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-301 Clinical Trial

A Follow-up Study to Evaluate the Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 3 Clinical Trial of ALLO-ASC-DFU-301

This is a follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-301) for 24 months

Study Overview

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

Detailed Description

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-301) for 24 months. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a Diabetic Foot Ulcer.

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

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

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 01830
    • Nowon Eulji Medical Center, Eulji University
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital
  • Chungcheongnam-do
    • Daejeon, Chungcheongnam-do, Korea, Republic of
      • Chungnam National University Hospital
  • Gyeonggi-do
    • Bucheon, Gyeonggi-do, Korea, Republic of, 14584
      • Soonchunhyang University Hospital
    • Seongnam, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
    • Suwon, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University Medical Center
  • Gyeongsangnam-do
    • Daegu, Gyeongsangnam-do, Korea, Republic of, 42601
      • Keimyung University Dongsan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-301.

Description

Inclusion Criteria:

1. Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-301.
2. Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Subjects who are considered not suitable for the study by the principal investigator.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ALLO-ASC-DFU; Subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial of ALLO-ASC-DFU-301	Biological: ALLO-ASC-DFU; Application of ALLO-ASC-DFU sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.
Vehicle sheet; Subjects with Vehicle sheet treatment in phase 3 clinical trial of ALLO-ASC-DFU-301	Procedure: Vehicle sheet; Application of Vehicle sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of systemic tolerance through incidence of abnormal laboratory test results	Up to 9 months
Evaluation of incidence of clinically significant change in physical examination and vital signs	Up to 18 months
Evaluation of localized tolerance through incidence of clinically significant change about treatment area	Up to 24 months
Evaluation of incidence of adverse events	Up to 24 months

Collaborators and Investigators

• Sponsor: Anterogen Co., Ltd.
• Investigators: Principal Investigator: SeungKyu Han, MD. Ph D., Korea University Guro Hospital; Principal Investigator: KiWon Young, MD. Ph D., Nowon Eulji Medical Center, Eulji University; Principal Investigator: Junpyo Hong, MD. Ph D., Asan Medical Center; Principal Investigator: Junhyeong Kim, MD. Ph D., Keimyung University Dongsan Medical Center; Principal Investigator: Chan Kang, MD. Ph D., Chungnam National University Hospital; Principal Investigator: Hyungmin Hahn, MD. Ph D., Ajou University Medical Center; Principal Investigator: ChanYeong Heo, MD. Ph D., Seoul National University Bundang Hospital; Principal Investigator: Youngkoo Lee, MD. Ph D., Soonchunhyang University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): June 2, 2023

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 19, 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: 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
• Other Study ID Numbers: ALLO-ASC-DFU-303

Drug and device information, study documents

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