RecruitingNCT06141811

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


Sponsor

Anterogen Co., Ltd.

Enrollment

104 participants

Start Date

Apr 25, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 19 YearsMax Age: 75 Years

Inclusion Criteria2

  • Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-302.
  • Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria1

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

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Interventions

BIOLOGICALALLO-ASC-DFU

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

PROCEDUREVehicle sheet

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


Locations(4)

Soonchunhyang University Hospital

Bucheon-si, Gyeonggi-do, South Korea

Bucheon ST. Mary's Hospital

Bucheon-si, Gyeonggi-do, South Korea

Asan Medical Center

Seoul, South Korea

Borame Medical Center

Seoul, South Korea

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NCT06141811


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