Long-term safety follow-up of ALLO-ASC-DFU for diabetic foot ulcer
Watches safety over 24 months in people treated with ALLO-ASC-DFU for diabetic foot ulcer.
Key facts
- Who runs it
- Anterogen Co., Ltd.
- Where
- South Korea4 sites in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial
- Status
- Recruiting
- People taking part
- 104 people, planned
- Started
- 25 Apr 2023
- Planned end
- 31 Mar 2026
- Type of study
- Observational, 2 groups
- Treatments tested
- ALLO-ASC-DFU
- Vehicle sheet
- Record updated
- 13 December 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with a diabetic foot ulcer who were treated in the ALLO-ASC-DFU-302 phase 3 trial. It follows their safety for 24 months.
- Age
- 19 Years to 75 Years
- Sex
- All
- Disease stage
- Diabetic foot ulcer
- Earlier treatment
- Must have been treated with the ALLO-ASC-DFU sheet or the Vehicle sheet (a sheet without the active cells) in the ALLO-ASC-DFU-302 trial.
Main reasons for not taking part
- People the lead study doctor judges should not take part cannot join.
- People unable to give written consent or follow the study rules cannot join.
The registry criteria, word for word
Show all 3 criteriaShow less
Who can take part
- 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
Who cannot take part
- Subjects who are considered not suitable for the study by the principal investigator
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 19 and 75 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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
The 2 groups in the trial
- ALLO-ASC-DFU
Subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial of ALLO-ASC-DFU-302
- Vehicle sheet
Subjects with Vehicle sheet treatment in phase 3 clinical trial of ALLO-ASC-DFU-302
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial
- Plain-language title
- Long-term safety follow-up of ALLO-ASC-DFU for diabetic foot ulcerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Fit questions
- Built from NCT06141811, who can take part
- Record updated
- 13 December 2024