A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial
- Conditions
- Diabetic Foot Ulcer
- Interventions
- Procedure: Vehicle sheet
- Registration Number
- NCT06141811
- Lead Sponsor
- Anterogen Co., Ltd.
- Brief 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
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 104
- 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.
- Subjects who are considered not suitable for the study by the principal investigator.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Vehicle sheet Vehicle sheet Subjects with Vehicle sheet treatment in phase 3 clinical trial of ALLO-ASC-DFU-302 ALLO-ASC-DFU ALLO-ASC-DFU Subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial of ALLO-ASC-DFU-302
- Primary Outcome Measures
Name Time Method Evaluation of incidence of adverse events Up to 24 months 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Soonchunhyang University Hospital
🇰🇷Bucheon, Gyeonggi-do, Korea, Republic of
Bucheon ST. Mary's Hospital
🇰🇷Bucheon, Gyeonggi-do, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Borame Medical Center
🇰🇷Seoul, Korea, Republic of