Clinical Trial: Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 1/2 Clinical Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa
Brief Summary: This is a phase I/II open-label study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Dystrophic Epidermolysis Bullosa.
Detailed Summary: 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 an new option in treating a Dystrophic Epidermolysis Bullosa.
Sponsor: Anterogen Co., Ltd.
Current Primary Outcome: Area of re-epithelization [ Time Frame: Follow up to 8 weeks ]
Original Primary Outcome: Safety assessed by clincally measured abnormality of laboratory tests and adverse events [ Time Frame: Follow up to 4 weeks ]
Current Secondary Outcome:
- Percentage of a target wound's re-epithelialization [ Time Frame: Every time of visit for follow up to 8 weeks ]
- Time taken to re-epithelization [ Time Frame: Over 8 weeks ]
- Safety assessed by clinically measured abnormality of laboratory tests and adverse events [ Time Frame: Over 8 weeks ]
Original Secondary Outcome:
- Percentage of a target wound's re-epithelialization [ Time Frame: Every time of visit for follow up to 4 weeks ]
- QoL questionnaire to assess subject's wound care satisfaction [ Time Frame: Week 4 ]
Information By: Anterogen Co., Ltd.
Dates:
Date Received: October 16, 2015
Date Started: October 2015
Date Completion: December 2017
Last Updated: January 1, 2017
Last Verified: January 2017
