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

NCT ID: NCT06141811

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-25

Study Completion Date

2026-03-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Diabetic Foot Ulcer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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ALLO-ASC-DFU

Subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial of ALLO-ASC-DFU-302

ALLO-ASC-DFU

Intervention Type BIOLOGICAL

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

Vehicle sheet

Intervention Type PROCEDURE

Application of Vehicle sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.

Interventions

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ALLO-ASC-DFU

Application of ALLO-ASC-DFU sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.

Intervention Type BIOLOGICAL

Vehicle sheet

Application of Vehicle sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anterogen Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ChangSik Park, MD. Ph D

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

JiUng Bak, MD. Ph D

Role: PRINCIPAL_INVESTIGATOR

Borame Medical Center

DaeWon Jun, MD. Ph D

Role: PRINCIPAL_INVESTIGATOR

Bucheon St. Mary's Hospital

YoungKoo Lee, MD. Ph D

Role: PRINCIPAL_INVESTIGATOR

Soonchunhyang University Hospital

Locations

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Soonchunhyang University Hospital

Bucheon-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Bucheon ST. Mary's Hospital

Bucheon-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Borame Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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ChangSik Park, MD. Ph D

Role: CONTACT

Phone: +82 2 3010 3600

Email: [email protected]

Facility Contacts

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YoungKoo Lee, MD. Ph D.

Role: primary

DaeWon Jun, MD. Ph D

Role: primary

ChangSik Park, MD. Ph D

Role: primary

JiUng Bak, MD. Ph D

Role: primary

Other Identifiers

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ALLO-ASC-DFU-304

Identifier Type: -

Identifier Source: org_study_id