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Clinical Trials in South Korea / NCT06141811
Recruiting Observational

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

NCT06141811 · tracked via the Priya Life Science South Korea tracker
Sponsor
Anterogen Co., Ltd
Phase
Observational
Started
2023-04-25
Last updated
2024-12-13

Condition(s) studied

Diabetic Foot Ulcer

Investigational drug(s) / intervention(s)

ALLO-ASC-DFUVehicle sheet

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

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

Study 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

Sex
ALL
Min age
19 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (4)

FacilityCityRegionStatus
Soonchunhyang University Hospital Bucheon-si Gyeonggi-do Recruiting
Bucheon ST. Mary's Hospital Bucheon-si Gyeonggi-do Recruiting
Asan Medical Center Seoul South Korea Recruiting
Borame Medical Center Seoul South Korea Recruiting

More Anterogen Co., Ltd. trials in South Korea

A Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in ALLO-ASC-CD-101 Clinical Trial Recruiting
Clinical Study to Evaluate Efficacy and Safety of ASC and Fibringlue or Fibringlue in Patients With Crohn's Fistula Active, not recruiting
Clinical Study to Evaluate Efficacy and Safety of ANT-301 in Patients With Knee Osteoarthritis in Grade III/IV by K/L Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06141811 on ClinicalTrials.gov ↗ ← All trials in South Korea