A Follow-up Study to Evaluate the Efficacy and Safety of ALLO-ASC-DFU in ALLO-ASC-EB-101 Clinical Trial
- Conditions
- Dystrophic Epidermolysis Bullosa
- Registration Number
- NCT03183934
- 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 1/2 clinical trial(ALLO-ASC-EB-101) for 24 months.
- Detailed Description
This is an open-label follow up study to evaluate the efficacy and safety for the subjects with ALLO-ASC-DFU treatment in phase 1/2 clinical trial (ALLO-ASC-EB-101) for 24 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 Dystrophic Epidermolysis Bullosa.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2
- Subjects who are treated with ALLO-ASC-DFU sheet in phase 1/2 clinical trial of ALLO-ASC-EB-101.
- 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 Safety assessed by clinically measured abnormality of laboratory tests and adverse events Every time of visit for follow up to 24 months Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
- Secondary Outcome Measures
Name Time Method Area of re-epithelization Every time of visit for follow up to 24 months Time taken to re-epithelization
Trial Locations
- Locations (1)
Gangnam Severence Hospital
🇰🇷Seoul, Korea, Republic of