A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-302.
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Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.
Exclusion Criteria:
- Subjects who are considered not suitable for the study by the principal investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Soonchunhyang University Hospital | Bucheon | Gyeonggi-do | Korea, Republic of | 14584 |
| 2 | Bucheon ST. Mary's Hospital | Bucheon | Gyeonggi-do | Korea, Republic of | 14647 |
| 3 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
| 4 | Borame Medical Center | Seoul | Korea, Republic of | 07061 |
Sponsors and Collaborators
- Anterogen Co., Ltd.
Investigators
- Principal Investigator: ChangSik Park, MD. Ph D, Asan Medical Center
- Principal Investigator: JiUng Bak, MD. Ph D, Borame 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- ALLO-ASC-DFU-304