Follow-up evaluation of ALLO-ASC-DFU treatment for diabetic foot ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.