A Follow-up Study to Evaluate the Efficacy and Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 1/2 Clinical Trial of ALLO-ASC-EB-101
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Safety assessed by clinically measured abnormality of laboratory tests and adverse events
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 2 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects who are treated with ALLO-ASC-DFU sheet in phase 1/2 clinical trial of ALLO-ASC-EB-
- •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.
Exclusion Criteria
- •Subjects who are considered not suitable for the study by the principal investigator.
Outcomes
Primary Outcomes
Safety assessed by clinically measured abnormality of laboratory tests and adverse events
Time Frame: Every time of visit for follow up to 24 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Secondary Outcomes
- Area of re-epithelization(Every time of visit for follow up to 24 months)