A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-BI-201 Clinical Trial
- Conditions
- Burn
- Registration Number
- NCT03183648
- Lead Sponsor
- Anterogen Co., Ltd.
- Brief Summary
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-BI-201) for 23 months.
- Detailed Description
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-BI-201) for 23 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 burn.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- Subjects who are treated with ALLO-ASC-DFU sheet in phase 2 clinical trial of ALLO-ASC-BI-201.
- A subject who is willing to follow the protocol and provide informed consent on screening, given that the information with respect to the clinical trial is provided.
- Subjects who are considered not suitable for the study by the principal investigator.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events as a Measure of Safety and Tolerability up to 24 months Evaluation of AE
- Secondary Outcome Measures
Name Time Method Vancouver Burn Scar Scale Every time of visit for follow up to 24 weeks Evaluation of Vancouver Burn Scar Scale
Trial Locations
- Locations (1)
Hallym university Medical Center
🇰🇷Seoul, Korea, Republic of