A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial

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-302) for 24 months

Study Overview

• Status: Recruiting
• 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-302) 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 (Estimated): 104

Contacts and Locations

• Study Contact: Name: ChangSik Park, MD. Ph D; Phone Number: +82 2 3010 3600; Email: iloveps.jcp@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Asan Medical Center
    • Contact: ChangSik Park, MD. Ph D; Phone Number: +82 2 3010 3600; Email: iloveps.jcp@gmail.com
  • Seoul, Korea, Republic of, 07061
    • Recruiting
    • Borame Medical Center
    • Contact: JiUng Bak, MD. Ph D; Phone Number: +82 2 870 2332; Email: alfbskan@gmail.com
  • Gyeonggi-do
    • Bucheon, Gyeonggi-do, Korea, Republic of, 14584
      • Recruiting
      • Soonchunhyang University Hospital
      • Contact: YoungKoo Lee, MD. Ph D.; Phone Number: +82 32 621 6705; Email: brain0808@hanmail.net
    • Bucheon, Gyeonggi-do, Korea, Republic of, 14647
      • Recruiting
      • Bucheon St. Mary's Hospital
      • Contact: DaeWon Jun, MD. Ph D; Phone Number: +82 10 9405 6543; Email: jundw430@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

ubjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-302.

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-302.
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?

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-302	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-302	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: JiUng Bak, MD. Ph D, Borame Medical Center; Principal Investigator: ChangSik Park, MD. Ph D, Asan Medical Center; Principal Investigator: DaeWon Jun, MD. Ph D, Bucheon St. Mary's Hospital; Principal Investigator: YoungKoo Lee, MD. Ph D, Soonchunhyang University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: ALLO-ASC-DFU-304

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