ALLO-ASC-SHEET for Epidermolysis Bullosa
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you require antibiotics for a bacterial infection on the target skin ulcer area, you may be excluded from the trial.
What data supports the effectiveness of the treatment ALLO-ASC-SHEET for Epidermolysis Bullosa?
Is ALLO-ASC-SHEET safe for use in humans?
What makes the ALLO-ASC-SHEET treatment unique for Epidermolysis Bullosa?
ALLO-ASC-SHEET uses adipose-derived stem cells, which are unique because they can transform into different types of cells and help repair damaged skin. This treatment is novel as it leverages the regenerative potential of these stem cells to promote healing in conditions like Epidermolysis Bullosa, where traditional treatments are limited.125610
What is the purpose of this trial?
After confirming eligibility, a single subject with four selected target lesions will receive both ALLO-ASC-SHEET and Vehicle control, three target lesions for ALLO-ASC-SHEET and the other target for Vehicle control, and which lesion to apply which IP treatment will be determined randomly at the time of enrollment using pre-designed block randomization scheme.
Eligibility Criteria
This trial is for individuals with dystrophic epidermolysis bullosa, confirmed by specific tests. Participants must have skin ulcers between 5-20 cm2 in size that are stable and not infected. Women who are pregnant, breastfeeding, or not using contraception if of childbearing potential cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ALLO-ASC-SHEET and Vehicle control treatments for target lesions
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ALLO-ASC-SHEET
- Vehicle Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Anterogen Co., Ltd.
Lead Sponsor