Actively Recruiting
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial
Led by Anterogen Co., Ltd. · Updated on 2024-12-13
104
Participants Needed
4
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the long-term safety of ALLO-ASC-DFU treatment in people who previously participated in a phase 3 clinical trial for Diabetic Foot Ulcer. ALLO-ASC-DFU is a hydrogel sheet containing stem cells from donated fat tissue that may help reduce inflammation and support wound healing. The study focuses on safety outcomes over a 24-month follow-up period. Participants in this open-label follow-up were previously treated with either the ALLO-ASC-DFU sheet or a Vehicle sheet during the earlier phase 3 trial. There is no new treatment given in this follow-up. The study observes the participants who received these treatments to monitor for any safety concerns over two years. During the study, researchers will monitor participants for abnormal lab test results up to 9 months, changes in physical exams and vital signs up to 18 months, and any local reactions at the treatment area up to 24 months. They will also track any adverse events throughout the 24 months. Participants will be involved in regular assessments to evaluate these safety outcomes under medical supervision.
CONDITIONS
Brief Title
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects who were treated with ALLO-ASC-DFU sheet or Vehicle sheet in the phase 3 clinical trial ALLO-ASC-DFU-302
- Able to provide written informed consent before starting the study
- Able to comply with all study requirements
You will not qualify if you...
- Subjects considered not suitable for the study by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants who received ALLO-ASC-DFU or Vehicle sheet treatment in a previous trial are observed for safety over time.
Regular visits for safety assessments up to 24 months
Trial Site Locations
Total: 4 locations
1
Soonchunhyang University Hospital
Bucheon-si, Gyeonggi-do, South Korea, 14584
Actively Recruiting
2
Bucheon ST. Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea, 14647
Actively Recruiting
3
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
4
Borame Medical Center
Seoul, South Korea, 07061
Actively Recruiting
Research Team
C
ChangSik Park, MD. Ph D
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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