Follow-up evaluation of ALLO-ASC-DFU treatment for diabetic foot ulcers
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial
This study is testing a special hydrogel treatment with stem cells to see if it can help heal diabetic foot ulcers safely over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 104 (estimated) |
| Ages | 19 Years to 75 Years |
| Sex | All |
| Sponsor | Anterogen Co., Ltd. Industry-sponsored |
| Locations | 4 sites (Bucheon-si, Gyeonggi-do and 3 other locations) |
| Trial ID | NCT06141811 on ClinicalTrials.gov |
What this trial studies
This follow-up study assesses the safety of ALLO-ASC-DFU, a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells, in patients who participated in the phase 3 clinical trial ALLO-ASC-DFU-302. The study will monitor subjects for 24 months to evaluate the treatment's effects on wound healing and tissue regeneration. The adipose-derived stem cells are known for their anti-inflammatory properties and ability to release growth factors that may enhance healing in diabetic foot ulcers.
Who should consider this trial
Good fit: Ideal candidates are individuals who participated in the ALLO-ASC-DFU-302 trial and received either the ALLO-ASC-DFU or vehicle sheet.
Not a fit: Patients who were not suitable for the original trial or those excluded by the principal investigator may not benefit from this follow-up study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for improving healing in patients with diabetic foot ulcers.
How similar studies have performed: Other studies involving adipose-derived stem cells have shown promise in enhancing wound healing, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bucheon-si, Gyeonggi-do and 3 other locations
- Soonchunhyang University Hospital — Bucheon-si, Gyeonggi-do, South Korea (Recruiting)
- Bucheon ST. Mary's Hospital — Bucheon-si, Gyeonggi-do, South Korea (Recruiting)
- Asan Medical Center — Seoul, South Korea (Recruiting)
- Borame Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: ChangSik Park, MD. Ph D — Asan Medical Center
- Study coordinator: ChangSik Park, MD. Ph D
- Email: iloveps.jcp@gmail.com
- Phone: +82 2 3010 3600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.